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SDTM Terminology

This document provides definitions and metadata for various controlled terminology codes used in CDISC SDTM. It includes the NCI code, CDISC submission value, codelist name, definition, and whether the codelist is extensible for over 50 terms. Some example terms included are action taken with study treatment, acute coronary syndrome presentation category, adverse event severity scale, age span, and anatomical location.

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Suri Vijay
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2K views

SDTM Terminology

This document provides definitions and metadata for various controlled terminology codes used in CDISC SDTM. It includes the NCI code, CDISC submission value, codelist name, definition, and whether the codelist is extensible for over 50 terms. Some example terms included are action taken with study treatment, acute coronary syndrome presentation category, adverse event severity scale, age span, and anatomical location.

Uploaded by

Suri Vijay
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF, TXT or read online on Scribd
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CDISC SDTM Controlled Terminology, 2012-06-29

NCI Code C66767 C101832 CDISC Submission Value ACN ACSPCAT Codelist Extensible No No

Codelist Name Action Taken with Study Treatment Acute Coronary Syndrome Presentation Category Severity/Intensity Scale for Adverse Events Age Span Age Unit Canadian Cardiovascular Society Classification Coronary Artery Disease Presentation Coronary Artery Disease Risk Coronary Artery Disease Symptoms Coronary Artery Dominance Consensus Cardiac Classification System Test Name Consensus Cardiac Classification System Test Code Country

CDISC Definition Action Taken with Study Treatment A classification of the presentation of acute coronary syndrome.

C66769 C66780 C66781 C101833 C101834 C101835 C101836 C101837 C101838

AESEV AGESPAN AGEU CACRDSC CADPRSN CADRISK CADSYMP CARTDOM CCRCLS

A scale that defines the degree or state of disease existing in a patient as a result of the occurrence of an adverse event. (NCI) Subgroups of populations based on age. (NCI) Those units of time that are routinely used to express the age of a subject. The anginal classifications as measured by the Canadian Cardiovascular Society grading scale. A terminology codelist associated with coronary artery disease presentation. A terminology codelist to describe the relative risk of coronary artery disease. A terminology codelist that contains symptoms associated with coronary artery disease. A codelist to describe whether the posterior descending artery comes from the right or left vessel system. Classification system test name for cardiac parameters that are authored or endorsed by organizations. Classification system test code for cardiac parameters that are authored or endorsed by organizations. A collective generic term that refers here to a wide variety of dependencies, areas of special sovereignty, uninhabited islands, and other entities in addition to the traditional countries or independent states. (NCI) The effect that a cardiac rhythm device malfunction had on the ability to stimulate the heart. The reason that a Coronary Sinus Access or Left Ventricular (CS/LV) lead was not implanted. A terminology codelist to describe the findings test name from a cardiac examination. A terminology codelist to describe the findings test code from a cardiac examination. A terminology codelist to describe the severity of cardiac valvular stenosis. A terminology codelist to describe the severity of cardiac valvular regurgitation. The reason that a subject had a cardiac procedure. A terminology codelist to describe the extent of coronary artery disease. The name of the test for the drug accountability assessment.

No Yes No No No No No No Yes

C101839

CCRCLSCD

Yes

C66786

COUNTRY

No

C101840 C101841 C101842 C101843 C101844 C101845 C101846 C101847 C78731

CRYDFMAN CSLVLNIM CVEXAM CVEXAMCD CVLSTSEV CVLVRSEV CVPRCIND CVSLDEXT DATEST

Cardiac Rhythm Device Failure Manifestation Reason CS/LV Lead Not Implanted Cardiovascular Test Name Cardiovascular Test Code Cardiac Valvular Stenosis Severity Cardiac Valvular Regurgitation Severity Cardiac Procedure Indication Coronary Vessel Disease Extent Drug Accountability Test Name

Yes No Yes Yes No No Yes No Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 1 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


NCI Code C78732 C101848 C66788 C99074 C101849 C66734 CDISC Submission Value DATESTCD DIABTHPY DICTNAM DIR DISCHDX DOMAIN Codelist Extensible Yes Yes Yes Yes Yes Yes

Codelist Name Drug Accountability Test Code Diabetes Therapy Dictionary Name Directionality Discharge Disposition Domain Abbreviation

CDISC Definition The short name, or code, of the test for the drug accountability assessment. A terminology codelist that describes the treatment method for diabetes. A name given to a reference source that lists words and gives their meaning. (NCI) CDISC terminology for anatomical location or specimen further detailing directionality. The destination or circumstance at the time of discharge. A unique, 2-character domain code used in the regulatory submission process. The domain abbreviation is used consistently throughout the submission, i.e. in the dataset name, as the value of the domain variable within the dataset, and as a prefix for most variable names in the dataset. (CDISC Glossary) Classifications that describe and group pertinent events that occur throughout the conduct of a clinical trial. Terminology related to electrocardiogram lead names. Terminology codelist used with ECG Test Methods within CDISC. Terminology codelist used with ECG Findings and Abnormalities within CDISC. Terminology codelist used with ECG Test Names within CDISC. Terminology codelist used with ECG Tests within CDISC. The name of the EPOCH. A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. (NCI) The role that the individual or entity plays with respect to a specific situation or person. The terminology that includes terms pertaining to frequency within CDISC. The form of the completed pharmaceutical product, e.g. tablet, capsule, injection, elixir, suppository. Dosage form can have a significant effect on the onset, duration and intensity of the pharmacological action of a drug. A pharmaceutical dosage form controls the rate at which the drug is released into the biological fluids. This release rate affects its intrinsic absorption pattern and therefore, the bioavailability of the drug. Terminology used to describe the part of the graft that is most severely stenotic.

C74558 C90013 C71151 C71150 C71152 C71153 C99079 C66790

DSCAT EGLEAD EGMETHOD EGSTRESC EGTEST EGTESTCD EPOCH ETHNIC

Category for Disposition Event ECG Lead ECG Test Method ECG Result ECG Test Name ECG Test Code Epoch Ethnic Group

Yes Yes Yes Yes Yes Yes Yes Yes

C78735 C71113 C66726

EVAL FREQ FRM

Evaluator Frequency Pharmaceutical Dosage Form

Yes Yes Yes

C101853

GRSTNLOC

Location of Most Severe Stenosis Within a Graft Category for Inclusion/Exclusion Intervention Model Intervention Type Killip Class Responses

No

C66797 C99076 C99078 C101854

IECAT INTMODEL INTTYPE KILLIPC

A collection of criteria on which subjects are evaluated and that must be met by all study subjects. (NCI) The trial design developed to compare treatment groups. The kind of product or procedure studied in a trial. A terminology codelist based on the classification developed by Killip and Kimball, which classifies patients with myocardial infarction based on routine physical examination parameters, such as the presence or absence of rales, or a decreased systolic blood pressure. CDISC terminology for anatomical location or specimen further detailing the side(s) of interest. Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model.

No Yes No No

C99073 C67154

LAT LBTEST

Laterality Laboratory Test Name

Yes Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 2 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


NCI Code C65047 C101855 C101856 C74456 C101857 C101858 CDISC Submission Value LBTESTCD LEADABN LEADSTAT LOC LSNCMPX LVEFMRE Codelist Extensible Yes Yes Yes Yes No Yes

Codelist Name Laboratory Test Code Lead Abnormality Lead Status Anatomical Location Lesion Complexity Left Ventricular Ejection Fraction Measurement Result Marital Status Mechanical Circulatory Support Placement Timing Medical Evaluator Method Microorganism Microbiology Susceptibility Testing Result Category Never/Current/Former Classification Completion/Reason for Non-Completion Not Done Neoplasm Type

CDISC Definition Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. Terminology related to the complications of cardiac lead systems. The status of the lead. Terminology codelist used for anatomical location within CDISC. Terminology related to the risk of percutaneous coronary intervention for a particular lesion. Terminology for results of left ventricular ejection fraction assessments.

C76348 C101859

MARISTAT MCRCSPTM

A demographic parameter indicating a person's current conjugal status. A terminology codelist to describe the timing of mechanical circulatory support placement. The individual responsible for the medical assessment. Method is any technique or procedure (an action) that determines how an observation or clinical finding was made. Microorganisms, bacteria, fungi and other organisms. Used to categorize the result of a finding in a standard format.

Yes No

C96777 C85492 C85491 C85495

MEDEVAL METHOD MICROORG MSRESCAT

Yes Yes Yes No

C78738 C66727 C66789 C88025 C101860 C78736 C101861 C66742 C101862

NCF NCOMPLT ND NEOPLASM

A classification of usage or experience that falls into three categories; never, current, or former. The status of the subject's completion of the study or a segment of the study, or the reason the subject discontinued the study or segment of the study. Indicates a task, process or examination that has either not been initiated or completed. (NCI) The terminology that includes concepts relevant to benign or malignant tissue growth. A terminology codelist to describe a normal or abnormal response. A description of the results relative to the normal or expected range of values. A terminology codelist that contains reasons for non-system PCI delay. A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable. A terminology codelist based on the functional classification developed by the New York Heart Association (NYHA), for categorizing patients with defined or presumed cardiac disease. A condition or event that is attributed to the adverse event and is the result or conclusion of the adverse event. (NCI) Terminology relevant to the test names that describe the physical characteristics of an entity. Terminology relevant to the test codes that describe the physical characteristics of an entity.

Yes Yes No Yes No Yes No No No

NORMABNM Normal Abnormal Response NRIND NSYSPCID NY NYHAC Reference Range Indicator Non-system Reason for PCI Delay No Yes Response New York Heart Association Class Responses Outcome of Event Physical Properties Test Name Physical Properties Test Code

C66768 C95120 C95121

OUT PHSPRP PHSPRPCD

No Yes Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 3 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


NCI Code C85493 C85839 C85494 C99075 C71148 C101863 C101864 C74457 C100130 C78737 C66729 C101865 C96785 C96781 C96782 C74559 C101866 C66731 CDISC Submission Value PKPARM PKPARMCD PKUNIT PORTOT POSITION PROCEDUR PRURGNCY RACE RELSUB RELTYPE ROUTE RSKASMT RSSTRESC RSTEST RSTESTCD SCCD SDTHSDTP SEX Codelist Extensible Yes Yes Yes Yes Yes Yes No Yes Yes No Yes No Yes Yes Yes Yes No No

Codelist Name PK Parameters PK Parameters Code PK Parameter Units of Measure Portion/Totality Position Procedure Procedure Urgency Status Race Relationship to Subject Relationship Type Route of Administration Risk Assessment Tumor Response Result Tumor Response Assessment Test Name Tumor Response Assessment Test Code Subject Characteristic Code Sudden Death Syndrome Type Sex

CDISC Definition Parameters used to describe the time-concentration curve. Parameter codes used to describe the time-concentration curve. Units of measure needed for pharmacokinetic parameters. Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of an entity. Terminology codelist used with Body Position within CDISC. A terminology codelist to describe an activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. A terminology codelist that describes the degree of urgency for a procedure. Terminology codelist used to identify the race of an individual within the Clinical Data Interchange Standards Consortium Study Data Tabulation Model. The relationship of a person to a study subject. The description of relationship types between a record or set of records. The course by which a substance was administered in order to reach the site of action in the body. A terminology codelist to describe the risk of a disease, disorder or abnormal condition. The result of an assessment of tumor response to treatment or therapy. Terminology relevant to the test names that describe an assessment of tumor response to treatment or therapy. Terminology relevant to the test codes that describe an assessment of tumor response to treatment or therapy. A unique code representing each Subject Characteristic. A terminology codelist that describes syndromes or conditions that put a subject at risk for sudden death. The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI) The specific sex, either male, female, or mixed of the subject group being studied. (NCI) The physical magnitude of something. (NCI) A classification system used to categorize the sensitivity of a subject's skin to sunlight. A distinctive characteristic of the skin marked by the amount of sebum secreted by sebaceous glands. The physical state or quality of a biological specimen. The name and description of a biological specimen. The relative relationship of a timepoint to a reference timepoint. Describes the role the study plays in determining the interventions a subject receives. The name of a code list that contains terms to define the type of blinding for the trial. (NCI)

C66732 C66733 C76351 C74561 C78733 C78734 C66728 C99077 C66735

SEXPOP SIZE SKINCLAS SKINTYP SPECCOND SPECTYPE STENRF STYPE TBLIND

Sex of Participants Size Skin Classification Skin Type Specimen Condition Specimen Type Relation to Reference Period Study Type Trial Blinding Schema

No Yes Yes Yes Yes Yes No No Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 4 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


NCI Code C66785 C66787 CDISC Submission Value TCNTRL TDIGRP Codelist Extensible Yes Yes

Codelist Name Control Type Diagnosis Group

CDISC Definition Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) Acceptable values to describe TIMI Flow. The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) A standard terminology developed to report adverse events occurring in cancer clinical trials. Common terminology criteria for adverse events (CTCAE) are used in study adverse event summaries and Investigational New Drug reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI) The version 4.0 standard terminology developed to report adverse events occurring in cancer clinical trials. Common terminology criteria for adverse events (CTCAE) are used to study adverse event summaries and Investigational New Drug reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI) Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI) Terminology relevant to the test names that describe the measurement of a tumor. Terminology relevant to the test codes that describe the measurement of a tumor. Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema, and primary objective of trial. (NCI) Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema, and primary objective of trial. (NCI) The type of clinical trial performed e.g. efficacy, safety. (NCI) Terminology relevant to tumor identification results. Terminology relevant to the test names that describe tumor assessments for identification purposes. Terminology relevant to the test codes that describe tumor assessments for identification purposes. Terminology codelist used for units within CDISC. The unit used to record and describe the result of a test investigating a vital sign. (NCI) The name given to the test that analyzes a particular set of vital signs including temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI) The name given to the test that analyzes a particular set of vital signs including temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI)

C101867 C66736 C66784

TIMIFLOW TINDTP TOXGR

TIMI Flow Responses Trial Indication Type Common Terminology Criteria for Adverse Events

No Yes No

C87162

TOXGR

Common Terminology Criteria for Adverse Events V4.0

No

C66737

TPHASE

Trial Phase

Yes

C96778 C96779 C67152 C66738 C66739 C96780 C96783 C96784 C71620 C66770 C67153 C66741

TRTEST TRTESTCD TSPARM TSPARMCD TTYPE TUMIDENT TUTEST TUTESTCD UNIT VSRESU VSTEST VSTESTCD

Oncology Tumor Properties Test Name Oncology Tumor Properties Test Code Trial Summary Parameter Test Name Trial Summary Parameter Test Code Trial Type Tumor Identification Results Tumor Identification Test Name Tumor Identification Test Code Unit Units for Vital Signs Results Vital Signs Test Name Vital Signs Test Code

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 5 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66767 - ACN - Action Taken with Study Treatment Codelist extensible: No
CDISC Synonym

NCI Code C49503

CDISC Submission Value DOSE INCREASED

CDISC Definition An indication that a medication schedule was modified by addition; either by changing the frequency, strength or amount. (NCI) An indication that a medication schedule was maintained. (NCI) An indication that a medication schedule was modified by subtraction, either by changing the frequency, strength or amount. (NCI) An indication that a medication schedule was modified by temporarily terminating a prescribed regimen of medication. (NCI) An indication that a medication schedule was modified through termination of a prescribed regimen of medication. (NCI)

NCI Preferred Term Dose Increased

C49504 C49505

DOSE NOT CHANGED DOSE REDUCED

Dose Not Changed Dose Reduced

C49501

DRUG INTERRUPTED

Drug Interrupted

C49502

DRUG WITHDRAWN

Drug Withdrawn

C48660 C17998

NOT APPLICABLE UNKNOWN

NA; Not Applicable U; Unknown

Determination of a value is not relevant in the current context. (NCI) Not known, not observed, not recorded, or refused. (NCI)

Not Applicable Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 6 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101832 - ACSPCAT - Acute Coronary Syndrome Presentation Category Codelist extensible: No
CDISC Synonym NSTEMI; NON-STEMI Other STEMI

NCI Code C80383

CDISC Submission Value NON-ST ELEVATION MYOCARDIAL INFARCTION OTHER ST ELEVATION MYOCARDIAL INFARCTION STABLE ANGINA

CDISC Definition A myocardial infarction that does not produce elevation in the ST segments of the ECG. Different than the one(s) previously specified or mentioned. (NCI) A myocardial infarction that produces elevation in the ST segments of the ECG. Angina pectoris which has not recently changed in frequency, duration or intensity. Stable angina pectoris is relieved by rest or administration of oral, sublingual or transdermal antianginal medications. Angina pectoris (or equivalent type of ischemic discomfort) which has recently changed in frequency, duration, intensity, or occurs at rest.

NCI Preferred Term Non-ST Elevation Myocardial Infarction Other ST Elevation Myocardial Infarction by ECG Finding Stable Angina

C17649 C101888

C66914

C66911

UNSTABLE ANGINA

Unstable Angina

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 7 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66769 - AESEV - Severity/Intensity Scale for Adverse Events Codelist extensible: No
CDISC Synonym Grade 1; 1

NCI Code C41338

CDISC Submission Value MILD

CDISC Definition A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.

NCI Preferred Term Mild Adverse Event

C41339

MODERATE

Grade 2; 2

Moderate Adverse Event

C41340

SEVERE

Grade 3; 3

Severe Adverse Event

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 8 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66780 - AGESPAN - Age Span Codelist extensible: Yes
CDISC Synonym

NCI Code C27954

CDISC Submission Value ADOLESCENT (12-17 YEARS) ADULT (18-65) CHILDREN (2-11 YEARS) ELDERLY (> 65) IN UTERO

CDISC Definition A juvenile between the onset of puberty and maturity; in the state of development between puberty and maturity. (NCI) A person from 18 years to 65 years of age. (NCI) A person from 2 years to 11 years of age. (NCI) An age group comprised by people 65 years of age and older. (NCI) The period of time during which the embryo or fetus is present in the uterus of the female. Also describes the location of the embryo or fetus as being in the uterus in contrast to outside the uterus (ex utero). (NCI) A person from 28 days to 23 months of age. (NCI) An infant during the first month after birth. (NCI) An infant born prior to completion of the normal gestation period. (NCI)

NCI Preferred Term Adolescent

C49685 C49683 C16268 C49641

Adult 18-65 Years Old Children 2-11 Years Old Elderly In Utero

C49643 C16731 C49642

INFANT AND TODDLER (28 DAYS - 23 MONTHS) NEWBORN (0-27 DAYS) PRETERM NEWBORN INFANTS

Infant And Toddler Newborn Preterm Newborn Infant

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 9 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66781 - AGEU - Age Unit Codelist extensible: No
CDISC Synonym

NCI Code C25301

CDISC Submission Value DAYS

CDISC Definition The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours. This also refers to a specific day. (NCI) Day

NCI Preferred Term

C25529

HOURS

Hour; hr

A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI) Any period of seven consecutive days. (NCI) The period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period. (NCI)

Hour

C29846

MONTHS

Month

C29844 C29848

WEEKS YEARS

Week Year

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 10 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101833 - CACRDSC - Canadian Cardiovascular Society Classification Codelist extensible: No
CDISC Synonym Canadian Cardiovascular Society Classification 1 Canadian Cardiovascular Society Classification 2

NCI Code C77265

CDISC Submission Value CCS CLASS 1

CDISC Definition Ordinary physical activity, such as walking or climbing stairs, does not cause angina. Angina occurs with strenuous, rapid, or prolonged exertion at work or recreation. Slight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or climbing stairs after meals, or in cold, in wind, or under emotional stress, or only during the few hours after awakening. Angina occurs on walking more than 2 blocks on the level and climbing more than 1 flight of ordinary stairs at a normal pace and in normal conditions. Marked limitations of ordinary physical activity. Angina occurs on walking 1 to 2 blocks on the level and climbing 1 flight of stairs in normal conditions and at a normal pace. Inability to perform any physical activity without discomfort - anginal symptoms may be present at rest.

NCI Preferred Term Canadian Cardiovascular Society Grading Scale Class I

C77266

CCS CLASS 2

Canadian Cardiovascular Society Grading Scale Class II

C77267

CCS CLASS 3

Canadian Cardiovascular Society Classification 3 Canadian Cardiovascular Society Classification 4

Canadian Cardiovascular Society Grading Scale Class III

C77268

CCS CLASS 4

Canadian Cardiovascular Society Grading Scale Class IV

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 11 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101834 - CADPRSN - Coronary Artery Disease Presentation Codelist extensible: No
CDISC Synonym NSTEMI; NON-STEMI STEMI

NCI Code C80383

CDISC Submission Value NON-ST ELEVATION MYOCARDIAL INFARCTION ST ELEVATION MYOCARDIAL INFARCTION STABLE ANGINA

CDISC Definition A myocardial infarction that does not produce elevation in the ST segments of the ECG. A myocardial infarction that produces elevation in the ST segments of the ECG. Angina pectoris which has not recently changed in frequency, duration or intensity. Stable angina pectoris is relieved by rest or administration of oral, sublingual or transdermal antianginal medications. Angina pectoris (or equivalent type of ischemic discomfort) which has recently changed in frequency, duration, intensity, or occurs at rest. A variant form of angina pectoris caused by coronary artery vasospasm, usually occurring spontaneously and frequently associated with ST segment elevation.

NCI Preferred Term Non-ST Elevation Myocardial Infarction ST Elevation Myocardial Infarction by ECG Finding Stable Angina

C101888

C66914

C66911

UNSTABLE ANGINA

Unstable Angina

C66915

VARIANT ANGINA

Variant Angina

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 12 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101835 - CADRISK - Coronary Artery Disease Risk Codelist extensible: No
CDISC Synonym High Coronary Artery Disease Risk

NCI Code C99955

CDISC Submission Value HIGH CAD RISK

CDISC Definition The likelihood an individual will develop coronary artery disease is almost certain or greater than90%. (Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex. htm.) The likelihood an individual will develop coronary artery disease (CAD) is moderate or between 10% and 90%. (Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex. htm.) The individual has coronary artery disease (CAD). (Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex. htm.) The likelihood an individual will develop coronary artery disease (CAD) is minimal or less than10%.(Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL Jr. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). 2002. American College of Cardiology Web site. Available at: www.acc.org/clinical/guidelines/exercise/dirIndex. htm.)

NCI Preferred Term High Coronary Artery Disease Risk

C99966

INTERMEDIATE CAD RISK

Intermediate Coronary Artery Disease Risk

Intermediate Coronary Artery Disease Risk

C99968

KNOWN CAD

Known Coronary Artery Disease

Known Coronary Artery Disease

C99978

LOW CAD RISK

Low Coronary Artery Disease Risk

Low Coronary Artery Disease Risk

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 13 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101836 - CADSYMP - Coronary Artery Disease Symptoms Codelist extensible: No
CDISC Synonym

NCI Code C99917

CDISC Submission Value ATYPICAL CORONARY ARTERY DISEASE SYMPTOMS

CDISC Definition Sharp stabbing chest pain or reproduction of pain on palpation. Less common isolated presentations, primarily in older adults, include nausea and vomiting, diaphoresis, and unexplained fatigue. J Am Coll Cardiol, 2007; 50:1-157, doi:10.1016/j.jacc.2007.02.013 (Published online 6 August 2007). The finding of no indications of a particular disease or injury. A discomfort in the chest area that is not related to the heart. Deep, poorly localized chest or arm discomfort that is reproducibly associated with physical exertion or emotional stress and is relieved promptly (ie, in less than 5 minutes) with rest and/or the use of sublingual nitroglycerin. Some patients may have no chest discomfort but present solely with jaw, neck, ear, arm, shoulder, back, or epigastric discomfort or with unexplained dyspnea without discomfort. If these symptoms have a clear relationship to exertion or stress or are relieved promptly with nitrates, they should be considered equivalent to angina. J Am Coll Cardiol, 2007; 50:1-157, doi:10.1016/j.jacc.2007.02.013 (Published online 6 August 2007).

NCI Preferred Term Atypical Coronary Artery Disease Symptom

C3833 C78504 C100024

NO SYMPTOMS NON-CARDIAC CHEST PAIN TYPICAL CORONARY ARTERY DISEASE SYMPTOMS

Asymptomatic Non-Cardiac Chest Pain Typical Coronary Artery Disease Symptom

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 14 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101837 - CARTDOM - Coronary Artery Dominance Codelist extensible: No
CDISC Synonym

NCI Code C99941

CDISC Submission Value CO-DOMINANT

CDISC Definition The right coronary artery supplies the posterior descending artery (PDA) and the circumflex supplies the posterolateral artery (PLA). Thus, there is approximately equal contribution to the inferior surface of the left ventricle from both the left circumflex and right coronary arteries. The posterior descending artery (PDA) and posterolateral artery (PLA) arises from the left circumflex artery. The posterior descending artery (PDA) and posterolateral artery (PLA) arises from the right coronary artery.

NCI Preferred Term Co-Dominant Artery

C99971

LEFT DOMINANCE

Left Cardiac Artery Dominance

C99942

RIGHT DOMINANCE

Coronary Artery Right Dominance

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 15 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101838 - CCRCLS - Consensus Cardiac Classification System Test Name Codelist extensible: Yes
CDISC Synonym ACC/AHA Lesion Complexity Class Canadian CV Society Grading Scale

NCI Code C100032

CDISC Submission Value ACC/AHA Lesion Complexity Class

CDISC Definition A classification system for coronary stenosis based upon characteristics that influence the difficulty of percutaneous coronary revascularization. A finding associated with a patient based on the functional classification developed by the Canadian Cardiovascular Society (CCS), for categorizing patients with angina. The classification system comprises four classes, which are defined in terms of the level of physical activity associated with the subject's anginal symptoms. A finding associated with a patient based on the classification developed by Killip and Kimball, which classifies patients with myocardial infarction based on routine physical examination parameters, such as the presence or absence of rales, or a decreased systolic blood pressure. A finding associated with a patient based on the functional classification developed by the New York Heart Association (NYHA), for categorizing patients with defined or presumed cardiac disease. The classification system is based on the ability to engage in physical activity. The classification system comprises four classes, though NYHA Class III and Class IV are often aggregated for the purpose of outcomes analysis. A grading system for coronary blood flow based on the classification developed by the Thrombolysis in Myocardial Infarction Group. It classifies coronary blood flow into four classes based upon the angiographic appearance of the blood vessels.

NCI Preferred Term American College of Cardiology American Heart Association Lesion Complexity Class Canadian Cardiovascular Society Grading Scale

C66910

Canadian CV Society Grading Scale

C66916

Killip Class

Killip Class

Killip Class

C66909

New York Heart Association Class

New York Heart Association Class

New York Heart Association Class

C100021

TIMI Flow

TIMI Flow

Thrombolysis in Myocardial Infarction Flow

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 16 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101839 - CCRCLSCD - Consensus Cardiac Classification System Test Code Codelist extensible: Yes
CDISC Synonym Canadian CV Society Grading Scale

NCI Code C66910

CDISC Submission Value CCSGRDS

CDISC Definition A finding associated with a patient based on the functional classification developed by the Canadian Cardiovascular Society (CCS), for categorizing patients with angina. The classification system comprises four classes, which are defined in terms of the level of physical activity associated with the subject's anginal symptoms. A finding associated with a patient based on the classification developed by Killip and Kimball, which classifies patients with myocardial infarction based on routine physical examination parameters, such as the presence or absence of rales, or a decreased systolic blood pressure. A classification system for coronary stenosis based upon characteristics that influence the difficulty of percutaneous coronary revascularization. A finding associated with a patient based on the functional classification developed by the New York Heart Association (NYHA), for categorizing patients with defined or presumed cardiac disease. The classification system is based on the ability to engage in physical activity. The classification system comprises four classes, though NYHA Class III and Class IV are often aggregated for the purpose of outcomes analysis. A grading system for coronary blood flow based on the classification developed by the Thrombolysis in Myocardial Infarction Group. It classifies coronary blood flow into four classes based upon the angiographic appearance of the blood vessels.

NCI Preferred Term Canadian Cardiovascular Society Grading Scale

C66916

KILLIPCL

Killip Class

Killip Class

C100032

LSNCPCLS

ACC/AHA Lesion Complexity Class New York Heart Association Class

American College of Cardiology American Heart Association Lesion Complexity Class New York Heart Association Class

C66909

NYHACLS

C100021

TIMIFLOW

TIMI Flow

Thrombolysis in Myocardial Infarction Flow

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 17 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym ARUBA AFGHANISTAN ANGOLA

NCI Code C17884 C16267 C16292

CDISC Submission Value ABW AFG AGO

CDISC Definition Island in the Caribbean Sea, north of Venezuela. (NCI) A country in Southern Asia, north and west of Pakistan, east of Iran. (NCI) A country in Southern Africa, bordering the South Atlantic Ocean, between Namibia and Democratic Republic of the Congo. (NCI) An island in the Caribbean Sea, east of Puerto Rico. (NCI) An archipelago in the Baltic Sea at the entrance to the Gulf of Bothnia between Sweden and Finland. (NCI) A country in Southeastern Europe, bordering the Adriatic Sea and Ionian Sea, between Greece and Serbia and Montenegro. (NCI) A country in Southwestern Europe, between France and Spain. (NCI) A country in the Middle East, bordering the Gulf of Oman and the Persian Gulf, between Oman and Saudi Arabia. (NCI) A country in Southern South America, bordering the South Atlantic Ocean, between Chile and Uruguay. (NCI) A country in Southwestern Asia, east of Turkey. (NCI) A group of islands in the South Pacific Ocean, about half way between Hawaii and New Zealand. (NCI) The continent lying mostly south of the Antarctic Circle. (NCI) Islands in the southern Indian Ocean, south of Africa, about equidistant between Africa, Antarctica, and Australia. (NCI) Islands between the Caribbean Sea and the North Atlantic Ocean, east-southeast of Puerto Rico. (NCI) The continent between the Indian Ocean and the South Pacific Ocean. (NCI) A country in Central Europe, north of Italy and Slovenia. (NCI) A country in Southwestern Asia, bordering the Caspian Sea, between Iran and Russia. (NCI) A country in Central Africa, east of Democratic Republic of the Congo. (NCI) A country in Western Europe, bordering the North Sea, between France and the Netherlands. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Nigeria and Togo. (NCI) Aruba

NCI Preferred Term

Afghanistan Angola

C20133 C44481 C16271

AIA ALA ALB

ANGUILLA ALAND ISLANDS ALBANIA

Anguilla Aland Islands Albania

C16289 C17232

AND ARE

ANDORRA UNITED ARAB EMIRATES ARGENTINA

Andorra United Arab Emirates

C16305

ARG

Argentina

C16306 C17739 C18007 C20105

ARM ASM ATA ATF

ARMENIA AMERICAN SAMOA ANTARCTICA FRENCH SOUTHERN TERRITORIES ANTIGUA AND BARBUDA AUSTRALIA AUSTRIA AZERBAIJAN BURUNDI BELGIUM BENIN REPUBLIC

Armenia American Samoa Antarctica French Southern Territories

C16303 C16311 C16312 C16316 C16371 C16329 C16333

ATG AUS AUT AZE BDI BEL BEN

Antigua and Barbuda Australia Austria Azerbaijan Burundi Belgium Benin

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 18 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym Bonaire, Sint Eustatius and Saba

NCI Code C101224

CDISC Submission Value BES

CDISC Definition Three Caribbean islands that are part of the Lesser Antilles; Bonaire is east of Aruba and Curacao off the coast of Venezuela, Sint Eustatius and Saba are located south of Sint Maarten and northeast of Saint Kitts and Nevis. (NCI)

NCI Preferred Term Bonaire, Sint Eustatius and Saba

C16369 C16323 C16368 C16322 C16321 C16361 C83609 C16372 C16331 C16334 C16359 C16364 C16324 C16367 C16336 C20104 C16363 C16409

BFA BGD BGR BHR BHS BIH BLM BLR BLZ BMU BOL BRA BRB BRN BTN BVT BWA CAF

BURKINA FASO A country in Western Africa, north of Ghana. (NCI) BANGLADESH BULGARIA BAHRAIN BAHAMAS A country in Southern Asia, bordering the Bay of Bengal, between Burma and India. (NCI) A country in Southeastern Europe, bordering the Black Sea, between Romania and Turkey. (NCI) An archipelago in the Persian Gulf, east of Saudi Arabia. (NCI) A chain of islands in the North Atlantic Ocean, southeast of Florida. (NCI)

Burkina Faso Bangladesh Bulgaria Bahrain Bahamas Bosnia and Herzegovina Saint Barthelemy Belarus Belize Bermuda Bolivia Brazil Barbados Brunei Darussalam Bhutan Bouvet Island Botswana Central African Republic

BOSNIA-HERZE A country in Southeastern Europe, bordering the GOVINA Adriatic Sea and Croatia. (NCI) SAINT BARTHELEMY BELARUS BELIZE BERMUDA BOLIVIA BRAZIL BARBADOS BRUNEI BHUTAN BOUVET ISLAND BOTSWANA CENTRAL AFRICAN REPUBLIC CANADA An island in the Caribbean sea, between Saint Martin and Saint Kitts and Nevis. (NCI) A country in Eastern Europe, east of Poland. (NCI) A country in Central America, bordering the Caribbean Sea, between Guatemala and Mexico. (NCI) A group of islands in the North Atlantic Ocean, east of South Carolina. (NCI) A country in Central South America, southwest of Brazil. (NCI) A country in Eastern South America, bordering the Atlantic Ocean. (NCI) An island between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela. (NCI) A country in Southeastern Asia, bordering the South China Sea and Malaysia. (NCI) A country in Southern Asia, between China and India. (NCI) An island in the South Atlantic Ocean, south-southwest of the Cape of Good Hope (South Africa). (NCI) A country in Southern Africa, north of South Africa. (NCI) A country in Central Africa, north of Democratic Republic of the Congo. (NCI) A country in Northern North America, bordering the North Atlantic Ocean on the east, North Pacific Ocean on the west, and the Arctic Ocean on the north, north of the conterminous US. (NCI)

C16380

CAN

Canada

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 19 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym COCOS (KEELING) ISLANDS SWITZERLAND CHILE

NCI Code C16445

CDISC Submission Value CCK

CDISC Definition A group of islands in the Indian Ocean, south of Indonesia, about halfway from Australia to Sri Lanka. (NCI) A country in Central Europe, east of France, north of Italy. (NCI) A country in Southern South America, bordering the South Atlantic Ocean and South Pacific Ocean, between Argentina and Peru. (NCI) A country in Eastern Asia, bordering the East China Sea, Korea Bay, Yellow Sea, and South China Sea, between North Korea and Vietnam. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Ghana and Liberia. (NCI) A country in Western Africa, bordering the Bight of Biafra, between Equatorial Guinea and Nigeria. (NCI) A country in Central Africa, northeast of Angola. (NCI) A country in Western Africa, bordering the South Atlantic Ocean, between Angola and Gabon. (NCI)

NCI Preferred Term Cocos (Keeling) Islands

C17181 C16427

CHE CHL

Switzerland Chile

C16428

CHN

CHINA

China

C16762 C16379 C17266

CIV CMR COD

COTE D'IVOIRE CAMEROON DEMOCRATIC REPUBLIC OF THE CONGO CONGO

Cote d'Ivoire Cameroon Congo, the Democratic Republic of the Congo Cook Islands

C16467 C16469

COG COK

COOK ISLANDS A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. (NCI) COLOMBIA A country in Northern South America, bordering the Caribbean Sea, between Panama and Venezuela, and bordering the North Pacific Ocean, between Ecuador and Panama. (NCI) A group of islands in the Mozambique Channel, about two-thirds of the way between northern Madagascar and northern Mozambique. (NCI) A group of islands in the North Atlantic Ocean, west of Senegal. (NCI) A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Nicaragua and Panama. (NCI) An island between the Caribbean Sea and the North Atlantic Ocean, 150 km south of Key West, Florida. (NCI) An island nation located in the Caribbean Sea off the coast of Venezuela. (NCI) An Australian-administered island in the eastern Indian Ocean south of Java, Indonesia. (NCI) An island group in the Caribbean Sea, nearly one-half of the way from Cuba to Honduras. (NCI) An island in the Mediterranean Sea, south of Turkey. (NCI)

C16449

COL

Colombia

C16458

COM

COMOROS

Comoros

C16382 C16470

CPV CRI

CAPE VERDE COSTA RICA

Cape Verde Costa Rica

C16477

CUB

CUBA

Cuba

C101225 C44482 C16391 C16480

CUW CXR CYM CYP

Curacao CHRISTMAS ISLAND CAYMAN ISLANDS CYPRUS

Curacao Christmas Island Cayman Islands Cyprus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 20 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym CZECH REPUBLIC GERMANY

NCI Code C17668 C16636

CDISC Submission Value CZE DEU

CDISC Definition A country in Central Europe, southeast of Germany. (NCI) A country in Central Europe, bordering the Baltic Sea and the North Sea, between the Netherlands and Poland, south of Denmark. (NCI) A country in Eastern Africa, bordering the Gulf of Aden and the Red Sea, between Eritrea and Somalia. (NCI) An island between the Caribbean Sea and the North Atlantic Ocean, about one-half of the way from Puerto Rico to Trinidad and Tobago. (NCI) A country in Northern Europe, bordering the Baltic Sea and the North Sea, on a peninsula north of Germany (Jutland); also includes two major islands (Sjaelland and Fyn). (NCI) A country comprising the eastern two-thirds of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, east of Haiti. (NCI) A country in Northern Africa, bordering the Mediterranean Sea, between Morocco and Tunisia. (NCI) A country in Western South America, bordering the Pacific Ocean at the Equator, between Colombia and Peru. (NCI) A country in Northern Africa, bordering the Mediterranean Sea, between Libya and the Gaza Strip. (NCI) A country in Eastern Africa, bordering the Red Sea, between Djibouti and Sudan. (NCI) A country in Northern Africa, bordering the North Atlantic Ocean, between Mauritania and Morocco. (NCI) A country in Southwestern Europe, bordering the Bay of Biscay, Mediterranean Sea, North Atlantic Ocean, and Pyrenees Mountains, southwest of France. (NCI) A country in Eastern Europe, bordering the Baltic Sea and Gulf of Finland, between Latvia and Russia. (NCI) A country in Eastern Africa, west of Somalia. (NCI) A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, and Gulf of Finland, between Sweden and Russia. (NCI) An island group in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. (NCI) Islands in the South Atlantic Ocean, east of southern Argentina. (NCI)

NCI Preferred Term Czech Republic Germany

C16506

DJI

DJIBOUTI

Djibouti

C16519

DMA

DOMINICA

Dominica

C16496

DNK

DENMARK

Denmark

C16520

DOM

DOMINICAN REPUBLIC ALGERIA

Dominican Republic

C16274

DZA

Algeria

C16528

ECU

ECUADOR

Ecuador

C16530

EGY

EGYPT

Egypt

C16558 C20113

ERI ESH

ERITREA WESTERN SAHARA SPAIN

Eritrea Western Sahara

C17152

ESP

Spain

C16562 C16563 C16584

EST ETH FIN

ESTONIA ETHIOPIA FINLAND

Estonia Ethiopia Finland

C16582

FJI

FIJI

Fiji

C17954

FLK

FALKLAND ISLANDS

Falkland Islands (Malvinas)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 21 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym FRANCE

NCI Code C16592

CDISC Submission Value FRA

CDISC Definition A country in Western Europe, bordering the Bay of Biscay and English Channel, between Belgium and Spain, southeast of the UK; bordering the Mediterranean Sea, between Italy and Spain. (NCI) An island group between the Norwegian Sea and the North Atlantic Ocean, about one-half of the way from Iceland to Norway. (NCI) An island group in the North Pacific Ocean, about three-quarters of the way from Hawaii to Indonesia. (NCI) A country in Western Africa, bordering the Atlantic Ocean at the Equator, between Republic of the Congo and Equatorial Guinea. (NCI) A country in Western Europe, comprising islands, including the northern one-sixth of the island of Ireland, between the North Atlantic Ocean and the North Sea, northwest of France. (NCI) A country in Southwestern Asia, bordering the Black Sea, between Turkey and Russia. (NCI) The island of Guernsey and the other Channel Islands represent the last remnants of the medieval Dukedom of Normandy, which held sway in both France and England. Guernsey is a British crown dependency, but is not part of the UK. (NCI) A country in Western Africa, bordering the Gulf of Guinea, between Cote d'Ivoire and Togo. (NCI) A dependency in Southwestern Europe, bordering the Strait of Gibraltar, on the southern coast of Spain. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Sierra Leone. (NCI) Islands in the eastern Caribbean Sea, southeast of Puerto Rico. (NCI) A country in Western Africa, bordering the North Atlantic Ocean and Senegal. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Senegal. (NCI) A country in Western Africa, bordering the Bight of Biafra, between Cameroon and Gabon; composed of a mainland portion and five inhabited islands. (NCI) A country in Southern Europe, bordering the Aegean Sea, Ionian Sea, and the Mediterranean Sea, between Albania and Turkey. (NCI) An island between the Caribbean Sea and Atlantic Ocean, north of Trinidad and Tobago. (NCI) An island between the Arctic Ocean and the North Atlantic Ocean, northeast of Canada. (NCI) France

NCI Preferred Term

C16573

FRO

FAROE ISLANDS MICRONESIA, FEDERATED STATES OF GABON

Faroe Islands

C17881

FSM

Micronesia, Federated States of

C16596

GAB

Gabon

C17233

GBR

UNITED KINGDOM

United Kingdom

C16634 C64375

GEO GGY

GEORGIA GUERNSEY

Georgia Guernsey

C26330 C16638

GHA GIB

GHANA GIBRALTAR

Ghana Gibraltar

C16655

GIN

GUINEA

Guinea

C16651 C16598 C16656 C16557

GLP GMB GNB GNQ

GUADELOUPE GAMBIA GUINEA-BISSA U EQUATORIAL GUINEA GREECE

Guadeloupe Gambia Guinea-Bissau Equatorial Guinea

C16645

GRC

Greece

C16647 C16646

GRD GRL

GRENADA GREENLAND

Grenada Greenland

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 22 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym GUATEMALA

NCI Code C16654

CDISC Submission Value GTM

CDISC Definition A country in Central America, bordering the Caribbean Sea, between Honduras and Belize and bordering the North Pacific Ocean, between El Salvador and Mexico. (NCI) A country in Northern South America, bordering the North Atlantic Ocean, between Brazil and Suriname. (NCI) Island in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines. (NCI) A country in Northern South America, bordering the North Atlantic Ocean, between Suriname and Venezuela. (NCI) A special administrative region of China, bordering the South China Sea and China. (NCI)

NCI Preferred Term Guatemala

C16593

GUF

FRENCH GUIANA GUAM GUYANA

French Guiana

C16652 C16657

GUM GUY

Guam Guyana

C16695 C20106

HKG HMD

HONG KONG

Hong Kong

HEARD ISLAND Islands in the Indian Ocean, about two-thirds of the way Heard Island and McDonald Islands AND from Madagascar to Antarctica. (NCI) MCDONALD ISLANDS HONDURAS A country in Central America, bordering the Caribbean Sea, between Guatemala and Nicaragua and bordering the North Pacific Ocean, between El Salvador and Nicaragua. (NCI) A country in Southeastern Europe, bordering the Adriatic Sea, between Bosnia and Herzegovina and Slovenia. (NCI) A country comprising the western one-third of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, west of the Dominican Republic. (NCI) A country in Central Europe, northwest of Romania. (NCI) A country in Southeastern Asia, comprising the archipelago between the Indian Ocean and the Pacific Ocean. (NCI) An island in the Irish Sea, between Great Britain and Ireland. (NCI) A country in Southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Burma and Pakistan. (NCI) Honduras

C16694

HND

C16474

HRV

CROATIA

Croatia

C16660

HTI

HAITI

Haiti

C16699 C16728

HUN IDN

HUNGARY INDONESIA

Hungary Indonesia

C44480 C16727

IMN IND

ISLE OF MAN INDIA

Isle of Man India

C16365

IOT

BRITISH An archipelago in the Indian Ocean, about one-half the INDIAN OCEAN way from Africa to Indonesia. (NCI) TERRITORY IRELAND A country in Western Europe, occupying five-sixths of the island of Ireland in the North Atlantic Ocean, west of Great Britain. (NCI) A country in the Middle East, bordering the Gulf of Oman, the Persian Gulf, and the Caspian Sea, between Iraq and Pakistan. (NCI)

British Indian Ocean Territory

C16757

IRL

Ireland

C16755

IRN

IRAN

Iran, Islamic Republic of

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 23 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym IRAQ ICELAND

NCI Code C16756 C16704

CDISC Submission Value IRQ ISL

CDISC Definition A country in the Middle East, bordering the Persian Gulf, between Iran and Kuwait. (NCI) A country in Northern Europe, island between the Greenland Sea and the North Atlantic Ocean, northwest of the UK. (NCI) A country in the Middle East, bordering the Mediterranean Sea, between Egypt and Lebanon. (NCI) A country in Southern Europe, occupying a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. (NCI) An island in the Caribbean Sea, south of Cuba. (NCI) Jersey and the other Channel Islands represent the last remnants of the medieval Dukedom of Normandy that held sway in both France and England. Jersey is a British crown dependency, but is not part of the UK. (NCI) A country in the Middle East, northwest of Saudi Arabia. (NCI) A country in Eastern Asia, occupying an island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. (NCI) A country in Central Asia, northwest of China. (NCI) A country in Eastern Africa, bordering the Indian Ocean, between Somalia and Tanzania. (NCI) A country in Central Asia, west of China. (NCI) A country in Southeastern Asia, bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. (NCI) A group of 33 coral atolls in the Pacific Ocean, straddling the equator; the capital Tarawa is about one-half of the way from Hawaii to Australia. (NCI) Islands in the Caribbean Sea, about one-third of the way from Puerto Rico to Trinidad and Tobago. (NCI) A country in Eastern Asia, occupying the southern half of the Korean Peninsula, bordering the Sea of Japan and the Yellow Sea. (NCI) A country in the Middle East, bordering the Persian Gulf, between Iraq and Saudi Arabia. (NCI) A country in Southeastern Asia, northeast of Thailand, west of Vietnam. (NCI) A country in the Middle East, bordering the Mediterranean Sea, between Israel and Syria. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Cote d'Ivoire and Sierra Leone. (NCI) Iraq Iceland

NCI Preferred Term

C16760 C16761

ISR ITA

ISRAEL ITALY

Israel Italy

C16763 C64374

JAM JEY

JAMAICA JERSEY

Jamaica Jersey

C16765 C16764

JOR JPN

JORDAN JAPAN

Jordan Japan

C20107 C16769 C16771 C16378 C16639

KAZ KEN KGZ KHM KIR

KAZAKHSTAN KENYA KYRGYZSTAN CAMBODIA KIRIBATI

Kazakhstan Kenya Kyrgyzstan Cambodia Kiribati

C17885 C16774

KNA KOR

SAINT KITTS AND NEVIS SOUTH KOREA

Saint Kitts and Nevis Korea, Republic of

C16775 C16780

KWT LAO

KUWAIT LAO PEOPLE'S DEMOCRATIC REPUBLIC LEBANON LIBERIA

Kuwait Lao People's Democratic Republic

C16784 C16791

LBN LBR

Lebanon Liberia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 24 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym LIBYAN ARAB JAMAHIRIYA SAINT LUCIA

NCI Code C16793 C17113

CDISC Submission Value LBY LCA

CDISC Definition A country in Northern Africa, bordering the Mediterranean Sea, between Egypt and Tunisia. (NCI) A country in the Caribbean, occupying an island between the Caribbean Sea and North Atlantic Ocean, north of Trinidad and Tobago. (NCI) A country in Central Europe, between Austria and Switzerland. (NCI) A country in Southern Asia, occupying an island in the Indian Ocean, south of India. (NCI) A country in Southern Africa, an enclave of South Africa. (NCI) A country in Eastern Europe, bordering the Baltic Sea, between Latvia and Russia. (NCI) A country in Western Europe, between France, Belgium, and Germany. (NCI) A country in Eastern Europe, bordering the Baltic Sea, between Estonia and Lithuania. (NCI) A country in Eastern Asia, bordering the South China Sea and China. (NCI)

NCI Preferred Term Libyan Arab Jamahiriya Saint Lucia

C16794 C17163 C16787 C16799 C16803 C16783 C16807 C83610 C16878

LIE LKA LSO LTU LUX LVA MAC MAF MAR

LIECHTENSTEI N SRI LANKA LESOTHO LITHUANIA LUXEMBOURG LATVIA MACAO

Liechtenstein Sri Lanka Lesotho Lithuania Luxembourg Latvia Macao Saint Martin, French Morocco

SAINT MARTIN, An island in the Caribbean sea, between Anguilla and FRENCH Saint Barthelemy. (NCI) MOROCCO A country in Northern Africa, bordering the North Atlantic Ocean and the Mediterranean Sea, between Algeria and Western Sahara. (NCI) A country in Western Europe, bordering the Mediterranean Sea on the southern coast of France, near the border with Italy. (NCI) A country in Eastern Europe, northeast of Romania. (NCI) A country in Southern Africa, occupying an island in the Indian Ocean, east of Mozambique. (NCI) A country in Southern Asia, occupying a group of atolls in the Indian Ocean, south-southwest of India. (NCI) A country in Central America, bordering the Caribbean Sea and the Gulf of Mexico, between Belize and the US and bordering the North Pacific Ocean, between Guatemala and the US. (NCI) A group of atolls and reefs in the North Pacific Ocean, about one-half of the way from Hawaii to Australia. (NCI) A country in Southeastern Europe, north of Greece. (NCI) A country in Western Africa, southwest of Algeria. (NCI)

C16874

MCO

MONACO

Monaco

C16871 C16808 C16815

MDA MDG MDV

MOLDOVA, REPUBLIC OF MADAGASCAR MALDIVES

Moldova, Republic of Madagascar Maldives

C16850

MEX

MEXICO

Mexico

C16822

MHL

MARSHALL ISLANDS REPUBLIC OF MACEDONIA MALI

Marshall Islands

C17654 C16816

MKD MLI

Macedonia, the Former Yugoslav Republic of Mali

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 25 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym MALTA MYANMAR

NCI Code C16817 C16370

CDISC Submission Value MLT MMR

CDISC Definition A country in Southern Europe, occupying islands in the Mediterranean Sea, south of Sicily (Italy). (NCI) A country in Southeastern Asia, bordering the Andaman Sea and the Bay of Bengal, between Bangladesh and Thailand. (NCI) A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of Yugoslavia). (NCI) A country in Northern Asia, between China and Russia. (NCI) A country in the Pacific, comprising islands in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines. (NCI) A country in Southern Africa, bordering the Mozambique Channel, between South Africa and Tanzania. (NCI) A country in Northern Africa, bordering the North Atlantic Ocean, between Senegal and Western Sahara. (NCI) A country in the Caribbean, occupying an island in the Caribbean Sea, southeast of Puerto Rico. (NCI) An island in the Caribbean Sea, north of Trinidad and Tobago. (NCI) A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. (NCI) A country in Southern Africa, east of Zambia. (NCI) A country in Southeastern Asia, occupying a peninsula and the northern one-third of the island of Borneo, bordering Indonesia and the South China Sea, south of Vietnam. (NCI) A country in Southern Africa, occupying an island in the Mozambique Channel, about one-half of the way from northern Madagascar to northern Mozambique. (NCI) A country in Southern Africa, bordering the South Atlantic Ocean, between Angola and South Africa. (NCI) A country in the Pacific, comprised of islands in the South Pacific Ocean, east of Australia. (NCI) A country in Western Africa, southeast of Algeria. (NCI) A country in the Pacific, occupying an island in the South Pacific Ocean, east of Australia. (NCI) A country in Western Africa, bordering the Gulf of Guinea, between Benin and Cameroon. (NCI) Malta

NCI Preferred Term

Myanmar

C64378

MNE

MONTENEGRO

Montenegro

C16875 C17882

MNG MNP

MONGOLIA NORTHERN MARIANA ISLANDS MOZAMBIQUE

Mongolia Northern Mariana Islands

C16882

MOZ

Mozambique

C16826

MRT

MAURITANIA

Mauritania

C16876 C16823 C16827 C16813 C16814

MSR MTQ MUS MWI MYS

MONTSERRAT MARTINIQUE MAURITIUS MALAWI MALAYSIA

Montserrat Martinique Mauritius Malawi Malaysia

C16828

MYT

MAYOTTE

Mayotte

C16891

NAM

NAMIBIA

Namibia

C16913 C16916 C16919 C16917

NCL NER NFK NGA

NEW CALEDONIA NIGER NORFOLK ISLAND NIGERIA

New Caledonia Niger Norfolk Island Nigeria

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 26 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym NICARAGUA

NCI Code C16915

CDISC Submission Value NIC

CDISC Definition A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Costa Rica and Honduras. (NCI) A country in the Pacific, occupying an island in the South Pacific Ocean, east of Tonga. (NCI)

NCI Preferred Term Nicaragua

C16918 C16903 C16920 C16901 C16896 C16914 C16933

NIU NLD NOR NPL NRU NZL OMN

NIUE

Niue Netherlands Norway Nepal Nauru New Zealand Oman

NETHERLANDS A country in Western Europe, bordering the North Sea, between Belgium and Germany. (NCI) NORWAY NEPAL NAURU A country in Northern Europe, bordering the North Sea and the North Atlantic Ocean, west of Sweden. (NCI) A country in Southern Asia, between China and India. (NCI) A country in Oceania, occupying an island in the South Pacific Ocean, south of the Marshall Islands. (NCI)

NEW ZEALAND A country in the Pacific, comprised of islands in the South Pacific Ocean, southeast of Australia. (NCI) OMAN A country in the Middle East, bordering the Arabian Sea, Gulf of Oman, and Persian Gulf, between Yemen and the United Arab Emirates. (NCI) A country in Southern Asia, bordering the Arabian Sea, between India on the east and Iran and Afghanistan on the west and China in the north. (NCI) A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Colombia and Costa Rica. (NCI) A country in the Pacific, comprised of islands in the South Pacific Ocean, about midway between Peru and New Zealand. (NCI) A country in Western South America, bordering the South Pacific Ocean, between Chile and Ecuador. (NCI) A country in Southeastern Asia, comprised of an archipelago between the Philippine Sea and the South China Sea, east of Vietnam. (NCI) A country in the Pacific, comprising a group of islands in the North Pacific Ocean, southeast of the Philippines. (NCI) A country in Southeastern Asia, comprising a group of islands and including the eastern half of the island of New Guinea, between the Coral Sea and the South Pacific Ocean, east of Indonesia. (NCI) A country in Central Europe, east of Germany. (NCI) An island between the Caribbean Sea and the North Atlantic Ocean, east of the Dominican Republic. (NCI) A country in Eastern Asia, occupying the northern half of the Korean Peninsula, bordering the Korea Bay and the Sea of Japan, between China and South Korea. (NCI)

C16949

PAK

PAKISTAN

Pakistan

C16951

PAN

PANAMA

Panama

C16993

PCN

PITCAIRN

Pitcairn

C16972

PER

PERU

Peru

C16978

PHL

PHILIPPINES

Philippines

C17733

PLW

PALAU

Palau

C16952

PNG

PAPUA NEW GUINEA

Papua New Guinea

C17002 C17043 C16773

POL PRI PRK

POLAND PUERTO RICO NORTH KOREA

Poland Puerto Rico Korea, Democratic People's Republic of

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 27 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym PORTUGAL PARAGUAY PALESTINIAN TERRITORY, OCCUPIED FRENCH POLYNESIA QATAR REUNION ROMANIA RUSSIAN FEDERATION

NCI Code C17006 C16953 C20110

CDISC Submission Value PRT PRY PSE

CDISC Definition A country in Southwestern Europe, bordering the North Atlantic Ocean, west of Spain. (NCI) A country in Central South America, northeast of Argentina. (NCI) A collective name for the West Bank and the Gaza Strip, two territories in Palestine. (NCI) An archipelago in the South Pacific Ocean, about one-half of the way from South America to Australia. (NCI) A country in the Middle East, occupying a peninsula bordering the Persian Gulf and Saudi Arabia. (NCI) A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. (NCI) A country in Southeastern Europe, bordering the Black Sea, between Bulgaria and Ukraine. (NCI) A country in Northern Asia (that part west of the Urals is sometimes included with Europe), bordering the Arctic Ocean, between Europe and the North Pacific Ocean. (NCI) A country in Central Africa, east of Democratic Republic of the Congo. (NCI) A country in the Middle East, bordering the Persian Gulf and the Red Sea, north of Yemen. (NCI) A country in Northern Africa, bordering the Red Sea, between Egypt and Eritrea. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Mauritania. (NCI) A country in Southeastern Asia, comprised of islands between Malaysia and Indonesia. (NCI) A group of islands in the South Atlantic Ocean, east of the tip of South America. (NCI)

NCI Preferred Term Portugal Paraguay Palestinian Territory, Occupied

C16594

PYF

French Polynesia

C17045 C17095 C17108 C17111

QAT REU ROU RUS

Qatar Reunion Romania Russian Federation

C17112 C17117 C17170 C17121

RWA SAU SDN SEN

RWANDA SAUDI ARABIA SUDAN SENEGAL

Rwanda Saudi Arabia Sudan Senegal

C17134 C20111

SGP SGS

SINGAPORE SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS

Singapore South Georgia and the South Sandwich Islands

C17164 C17178

SHN SJM

SAINT HELENA Islands in the South Atlantic Ocean, about midway between South America and Africa. (NCI) SVALBARD AND JAN MAYEN SOLOMON ISLANDS SIERRA LEONE Islands between the Arctic Ocean, Barents Sea, Greenland Sea, and Norwegian Sea, northeast of Iceland and north of Norway. (NCI) A group of islands in the South Pacific Ocean, east of Papua New Guinea. (NCI) A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Liberia. (NCI)

Saint Helena Svalbard and Jan Mayen

C17148 C17130

SLB SLE

Solomon Islands Sierra Leone

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 28 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym EL SALVADOR

NCI Code C16532

CDISC Submission Value SLV

CDISC Definition A country in Central America, bordering the North Pacific Ocean, between Guatemala and Honduras. (NCI) A country in Southern Europe, an enclave in central Italy. (NCI) A country in Eastern Africa, bordering the Gulf of Aden and the Indian Ocean, east of Ethiopia. (NCI) A country in Northern North America, comprised of islands in the North Atlantic Ocean, south of Newfoundland (Canada). (NCI) A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of Yugoslavia). (NCI) A northeastern African country located in the Sahel region and bordered by Sudan in the north, Uganda and Kenya in the south and Ethiopia in the west. (NCI) A country in Western Africa, comprised of islands in the Gulf of Guinea, straddling the Equator, west of Gabon. (NCI) A country in Northern South America, bordering the North Atlantic Ocean, between French Guiana and Guyana. (NCI) A country in Central Europe, south of Poland. (NCI) A country in Central Europe, bordering the Adriatic Sea, between Austria and Croatia. (NCI) A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, Kattegat, and Skagerrak, between Finland and Norway. (NCI) A country in Southern Africa, between Mozambique and South Africa. (NCI)

NCI Preferred Term El Salvador

C17115 C17149 C17165

SMR SOM SPM

SAN MARINO SOMALIA SAINT PIERRE AND MIQUELON SERBIA

San Marino Somalia Saint Pierre and Miquelon

C64377

SRB

Serbia

C97351

SSD

South Sudan

South Sudan

C17116

STP

SAO TOME AND PRINCIPE SURINAME

Sao Tome and Principe

C17175

SUR

Suriname

C17669 C17138 C17180

SVK SVN SWE

SLOVAKIA SLOVENIA SWEDEN

Slovakia Slovenia Sweden

C17179 C101226 C17129

SWZ SXM SYC

SWAZILAND

Swaziland Sint Maarten (Dutch Part) Seychelles

SINT MAARTEN The southern portion of an island in the Caribbean sea, (DUTCH) between Anguilla and Saint Barthelemy. (NCI) SEYCHELLES A country in Eastern Africa, comprised of a group of islands in the Indian Ocean, northeast of Madagascar. (NCI) A country in the Middle East, bordering the Mediterranean Sea, between Lebanon and Turkey. (NCI) Two island groups in the North Atlantic Ocean, southeast of The Bahamas. (NCI) A country in Central Africa, south of Libya. (NCI) A country in Western Africa, bordering the Bight of Benin, between Benin and Ghana. (NCI)

C17182

SYR

SYRIAN ARAB REPUBLIC TURKS AND CAICOS ISLANDS CHAD TOGO

Syrian Arab Republic

C17224

TCA

Turks and Caicos Islands

C16412 C17202

TCD TGO

Chad Togo

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 29 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym THAILAND

NCI Code C17192

CDISC Submission Value THA

CDISC Definition A country in Southeastern Asia, bordering the Andaman Sea and the Gulf of Thailand, southeast of Burma. (NCI) A country in Central Asia, west of China. (NCI) A group of three atolls in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. (NCI)

NCI Preferred Term Thailand

C17183 C17704

TJK TKL

TAJIKISTAN TOKELAU

Tajikistan Tokelau

C17223 C17200

TKM TLS

TURKMENISTA A country in Central Asia, bordering the Caspian Sea, N between Iran and Kazakhstan. (NCI) TIMOR-LESTE A country in Southeastern Asia, northwest of Australia in the Lesser Sunda Islands at the eastern end of the Indonesian archipelago. East Timor includes the eastern half of the island of Timor, the Oecussi (Ambeno) region on the northwest portion of the island of Timor, and the islands of Pulau Atauro and Pulau Jaco. (NCI) An archipelago in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. (NCI)

Turkmenistan Timor-Leste

C17205

TON

TONGA

Tonga

C17217 C17221 C17222

TTO TUN TUR

TRINIDAD AND Islands between the Caribbean Sea and the North TOBAGO Atlantic Ocean, northeast of Venezuela. (NCI) TUNISIA TURKEY A country in Northern Africa, bordering the Mediterranean Sea, between Algeria and Libya. (NCI) A country in southeastern Europe and southwestern Asia (that portion of Turkey west of the Bosporus is geographically part of Europe), bordering the Black Sea, between Bulgaria and Georgia, and bordering the Aegean Sea and the Mediterranean Sea, between Greece and Syria. (NCI) An island group consisting of nine coral atolls in the South Pacific Ocean, about one-half of the way from Hawaii to Australia. (NCI) A group of islands bordering the East China Sea, Philippine Sea, South China Sea, and Taiwan Strait, north of the Philippines, off the southeastern coast of China. (NCI) A country in Eastern Africa, bordering the Indian Ocean, between Kenya and Mozambique. (NCI) A country in Eastern Africa, west of Kenya. (NCI) A country in Eastern Europe, bordering the Black Sea, between Poland and Russia. (NCI)

Trinidad and Tobago Tunisia Turkey

C17225

TUV

TUVALU

Tuvalu

C17184

TWN

TAIWAN

Taiwan, Province of China

C17185

TZA

TANZANIA, UNITED REPUBLIC OF UGANDA UKRAINE UNITED STATES MINOR OUTLYING ISLANDS URUGUAY

Tanzania, United Republic of

C17228 C17229 C20112

UGA UKR UMI

Uganda Ukraine

The U.S. Minor Outlying Islands consist of Baker United States Minor Outlying Islands Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Island, Navassa Island, Palmyra Atoll, and Wake Island (Wake Atoll). (NCI) A country in Southern South America, bordering the South Atlantic Ocean, between Argentina and Brazil. (NCI) Uruguay

C17244

URY

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 30 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66786 - COUNTRY - Country Codelist extensible: No
CDISC Synonym UNITED STATES UZBEKISTAN VATICAN CITY STATE SAINT VINCENT AND THE GRENADINES VENEZUELA

NCI Code C17234

CDISC Submission Value USA

CDISC Definition A country in North America, bordering both the North Atlantic Ocean and the North Pacific Ocean, between Canada and Mexico. (NCI) A country in Central Asia, north of Afghanistan. (NCI) An enclave of Rome (Italy). (NCI) A country in the Caribbean, comprised of islands in the Caribbean Sea, north of Trinidad and Tobago. (NCI)

NCI Preferred Term United States

C17246 C17249 C17114

UZB VAT VCT

Uzbekistan Holy See (Vatican City State) Saint Vincent and the Grenadines

C17250

VEN

A country in Northern South America, bordering the Caribbean Sea and the North Atlantic Ocean, between Colombia and Guyana. (NCI) Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. (NCI) Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. (NCI) A country in Southeastern Asia, bordering the Gulf of Thailand, Gulf of Tonkin, and South China Sea, alongside China, Laos, and Cambodia. (NCI) A group of islands in the South Pacific Ocean, about three-quarters of the way from Hawaii to Australia. (NCI) Islands in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. (NCI) A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. (NCI) A country in the Middle East, bordering the Arabian Sea, Gulf of Aden, and Red Sea, between Oman and Saudi Arabia. (NCI)

Venezuela

C17653

VGB

VIRGIN ISLANDS, BRITISH VIRGIN ISLANDS, U.S. VIETNAM

Virgin Islands, British

C17255 C17252

VIR VNM

Virgin Islands, U.S. Viet Nam

C17247

VUT

VANUATU

Vanuatu

C17259 C17740

WLF WSM

WALLIS AND FUTUNA SAMOA

Wallis and Futuna Samoa

C17264

YEM

YEMEN

Yemen

C17151 C17267 C17268

ZAF ZMB ZWE

SOUTH AFRICA A country in Southern Africa, at the southern tip of the continent of Africa. (NCI) ZAMBIA ZIMBABWE A country in Southern Africa, east of Angola. (NCI) A country in Southern Africa, between South Africa and Zambia. (NCI)

South Africa Zambia Zimbabwe

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 31 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101840 - CRYDFMAN - Cardiac Rhythm Device Failure Manifestation Codelist extensible: Yes
CDISC Synonym

NCI Code C99921 C99923 C99973 C100011

CDISC Submission Value ATRIAL PACING MALFUNCTION DEFIBRILLATION MALFUNCTION LEFT VENTRICULAR PACING MALFUNCTION RIGHT VENTRICULAR PACING MALFUNCTION

CDISC Definition The cardiac rhythm device malfunction affected atrial pacing. The cardiac rhythm device malfunction affected the defibrillator. The cardiac rhythm device malfunction affected the left ventricular (LV) pacing. The cardiac rhythm device malfunction affected the right ventricular (RV) pacing.

NCI Preferred Term Cardiac Atrial Pacing Malfunction Cardiac Defibrillator Malfunction Left Cardiac Ventricular Pacing Malfunction Right Cardiac Ventricle Pacing Malfunction

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 32 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101841 - CSLVLNIM - Reason CS/LV Lead Not Implanted Codelist extensible: No
CDISC Synonym

NCI Code C100025

CDISC Submission Value Could Not Obtain Acceptable Pacing Thresholds Lead Position Results in Undesirable Stimulation of the Diaphragm Previously Implanted

CDISC Definition The coronary sinus/left ventricular lead was not implanted because the operator was unable to obtain acceptable pacing thresholds. The coronary sinus/left ventricular lead was not implanted because the lead position resulted in undesirable stimulation of the diaphragm. The coronary sinus/left ventricular lead was not implanted because a lead had been previously implanted. The coronary sinus/left ventricular lead was not implanted because the operator was unable to obtain satisfactory coronary sinus access. The coronary sinus/left ventricular lead was not implanted because the operator was unable to obtain satisfactory vascular access. The coronary sinus/left ventricular lead was not implanted because the coronary sinus was dissected. The coronary sinus/left ventricular lead was not implanted because the operator was unable to position the lead in the tributary vein of the coronary sinus.

NCI Preferred Term Unable to Obtain Acceptable Pacing Thresholds Cardiac Lead Position Results in Undesirable Stimulation of Diaphragm Previously Implanted Cardiac Lead

C99933

C100007

C100026

Unable to Obtain Satisfactory Coronary Sinus Access Unable to Obtain Satisfactory Vascular Access Unable to Position Lead Due to Coronary Sinus Dissection Unable to Position Lead in Tributary Vein of Coronary Sinus

Unable to Obtain Satisfactory Coronary Sinus Access Unable to Obtain Satisfactory Vascular Access Unable to Position Lead Due to Coronary Sinus Dissection Unable to Position Lead In tributary Vein of Coronary Sinus

C100027

C100028 C100029

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 33 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101842 - CVEXAM - Cardiovascular Test Name Codelist extensible: Yes
CDISC Synonym

NCI Code C102244

CDISC Submission Value

CDISC Definition The qualitative measurement of the severity of cardiac valvular regurgitation. The qualitative measurement of the severity of cardiac valvular stenosis. The contribution of blood supply from the right or left vessel system to the posterior descending artery. (ACC) The percentage of myocardial tissue which exhibits characteristics of inadequate blood flow (ischemia). The diameter across the left atrium measured at the end of systole. The diameter across the ventricle at the end of diastole, excluding the thickness of the walls. The diameter across the ventricle at the end of systole, excluding the thickness of the walls. The percent or fraction of the left ventricular end diastolic volume ejected in systole. The left ventricular ejection fraction is equal to the left ventricular stroke volume divided by the left ventricular end diastolic volume. Number of major epicardial vessels with greater than or equal to 70% reduction in diameter or greater than or equal to 50% reduction in cross-sectional area.

NCI Preferred Term Cardiac Valvular Regurgitation Severity Cardiac Valvular Stenosis Severity Coronary Artery Dominance

Cardiac Valvular Regurgitation Cardiac Valvular Severity Regurgitation Severity Cardiac Valvular Stenosis Severity Coronary Artery Dominance Cardiac Valvular Stenosis Severity Coronary Artery Dominance Ischemic Myocardium Percentage Left Atrium Dimension Left Ventricle Dimension, End-Diastole Left Ventricular Dimension, End-Systole Left Ventricular Ejection Fraction

C102245 C100086

C80494

Ischemic Myocardium Percentage Left Atrium Dimension Left Ventricle Dimension, End-Diastole Left Ventricular Dimension, End-Systole Left Ventricular Ejection Fraction

Ischemic Myocardium Percentage

C99970 C99976

Left Atrium Dimension Left Ventricle Dimension at End-Diastole Left Ventricular Dimension at End-Systole Left Ventricle Ejection Fraction

C99977

C99524

C99996

Number of Diseased Coronary Vessels

Number of Diseased Coronary Vessels

Number of Diseased Coronary Artery Vessels

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 34 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101843 - CVEXAMCD - Cardiovascular Test Code Codelist extensible: Yes
CDISC Synonym Coronary Artery Dominance Cardiac Valvular Regurgitation Severity Cardiac Valvular Stenosis Severity Ischemic Myocardium Percentage Left Atrium Dimension Left Ventricle Dimension, End-Diastole Left Ventricular Dimension, End-Systole Left Ventricular Ejection Fraction

NCI Code C100086

CDISC Submission Value COARTDOM

CDISC Definition The contribution of blood supply from the right or left vessel system to the posterior descending artery. (ACC) The qualitative measurement of the severity of cardiac valvular regurgitation. The qualitative measurement of the severity of cardiac valvular stenosis. The percentage of myocardial tissue which exhibits characteristics of inadequate blood flow (ischemia). The diameter across the left atrium measured at the end of systole. The diameter across the ventricle at the end of diastole, excluding the thickness of the walls. The diameter across the ventricle at the end of systole, excluding the thickness of the walls. The percent or fraction of the left ventricular end diastolic volume ejected in systole. The left ventricular ejection fraction is equal to the left ventricular stroke volume divided by the left ventricular end diastolic volume. Number of major epicardial vessels with greater than or equal to 70% reduction in diameter or greater than or equal to 50% reduction in cross-sectional area.

NCI Preferred Term Coronary Artery Dominance

C102244

CVLREGTS

Cardiac Valvular Regurgitation Severity Cardiac Valvular Stenosis Severity Ischemic Myocardium Percentage

C102245 C80494

CVLSTNS ISHMYOP

C99970 C99976

LADMN LVDMNED

Left Atrium Dimension Left Ventricle Dimension at End-Diastole Left Ventricular Dimension at End-Systole Left Ventricle Ejection Fraction

C99977

LVDMNES

C99524

LVEF

C99996

NUMDCAV

Number of Diseased Coronary Vessels

Number of Diseased Coronary Artery Vessels

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 35 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101844 - CVLSTSEV - Cardiac Valvular Stenosis Severity Codelist extensible: No
CDISC Synonym

NCI Code C99986 C99990 C99992 C100013

CDISC Submission Value MILD CARDIAC VALVE STENOSIS MODERATE CARDIAC VALVE STENOSIS NO CARDIAC VALVE STENOSIS SEVERE CARDIAC VALVE STENOSIS

CDISC Definition The cardiac valve orifice is abnormally narrow, to a mild degree. The cardiac valve orifice is abnormally narrow, to a moderate degree. The cardiac valve orifice is not abnormally narrow. The cardiac valve orifice is abnormally narrow, to a severe degree.

NCI Preferred Term Mild Cardiac Valve Stenosis Moderate Cardiac Valve Stenosis No Cardiac Valve Stenosis Severe Cardiac Valve Stenosis

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 36 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101845 - CVLVRSEV - Cardiac Valvular Regurgitation Severity Codelist extensible: No
CDISC Synonym

NCI Code C99985 C99989 C99991 C100012

CDISC Submission Value MILD CARDIAC VALVE REGURGITATION MODERATE CARDIAC VALVE REGURGITATION NO CARDIAC VALVE REGURGITATION SEVERE CARDIAC VALVE REGURGITATION

CDISC Definition Evidence of mild retrograde blood flow through the valve(s) of the heart. Evidence of moderate retrograde blood flow through the valve(s) of the heart. No evidence of any retrograde blood flow through the valve(s) in the heart. Evidence of severe retrograde blood flow through the valve(s) of the heart.

NCI Preferred Term Mild Cardiac Valve Regurgitation Moderate Cardiac Valve Regurgitation No Cardiac Valve Regurgitation Severe Cardiac Valve Regurgitation

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CDISC SDTM Controlled Terminology, 2012-06-29


C101846 - CVPRCIND - Cardiac Procedure Indication Codelist extensible: Yes
CDISC Synonym

NCI Code C99919 C100033 C34830

CDISC Submission Value Candidate to Receive Cardiac Transplant Cardiac Arrest/Arrhythmia Etiology Unknown Cardiomyopathy

CDISC Definition The intended recipient of a heart transplant. An episode of cardiac arrest or arrhythmia where the etiology was unknown. A disease of the heart muscle or myocardium proper. Cardiomyopathies may be classified as either primary or secondary, on the basis of etiology, or on the pathophysiology of the lesion: hypertrophic, dilated, or restrictive. A longstanding, complete blockage of a vessel. The subject contributing a heart for a cardiac transplant. The battery that supplies the device has reached the end of its life. There is a faulty connector/header in the device. The device has a generator malfunction. A cardiac lead requires revision, at which time the generator to the device will be replaced. An immediate percutaneous coronary intervention is necessary for a myocardial infarction that presents with ST segment elevation. A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. -- 2003 (NCI) A cardiac lead has damaged local tissue enough to require treatment. The degree of impairment of the left cardiac ventricle to contract efficiently. An imperative issued by the manufacturer of a device that the device needs to be returned to a designated source for repair or replacement. The device manufacturer had recognized a recurrent performance failure in the device. The medical condition or the procedure affects the device implantation site. An intended medical or surgical procedure necessitates the relocation of a cardiac lead.

NCI Preferred Term Candidate to Receive Cardiac Transplant Cardiac Arrest Arrhythmia Etiology Unknown Cardiomyopathy

C99938 C99947 C99949 C100035 C99943 C99925 C99961

Chronic Total Occlusion Donor for Cardiac Transplant End of Expected Battery Life Faulty Connector/Header Generator Malfunction Generator is Being Replaced at the Time of Lead Revision Immediate Percutaneous Coronary Intervention (PCI) for St Elevation Myocardial Infarction (STEMI) Infection

Chronic Total Occlusion Vessel Donor for Cardiac Transplant End of Expected Battery Life Faulty Device Connector Header Device Generator Malfunction Cardiac Device Generator is Being Replaced at Time of Lead Revision Immediate Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction Infectious Disorder

C26726

C99931 C99974 C100045

Lead Erosion Left Ventricular Systolic Dysfunction Manufacturer Recall

Cardiac Lead Erosion Left Cardiac Ventricular Systolic Dysfunction Manufacturer Recall

C99980

Manufacturer Recognized a Recurring Performance Failure Medical Condition Or Procedure Affects Implantation Site Medical Or Surgical Procedure Requiring Relocation of Lead

Manufacturer Recognized a Recurring Performance Failure Medical Condition or Procedure Affects Implantation Site Medical or Surgical Procedure Requiring Relocation of Lead

C99982

C99983

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 38 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101846 - CVPRCIND - Cardiac Procedure Indication Codelist extensible: Yes
CDISC Synonym

NCI Code C99999

CDISC Submission Value Percutaneous Coronary Intervention (PCI) for High Risk Non-St Elevation Myocardial Infarction Or Unstable Angina

CDISC Definition Includes patients with unstable angina or Non-STEMI who have high risk features for short-term risk of death or nonfatal MI. High risk features includes at least one of the following: history of accelerating tempo of ischemic symptoms in preceding 48 hours; character of pain - prolonged ongoing (greater than 20 minutes) rest pain; clinical findings - pulmonary edema, most likely due to ischemia or new or worsening mitral regurgitation murmur; or S3 or new worsening rales or Hypotension, bradycardia, tachycardia or age greater than 75 years; ECG - angina at rest with transient ST-segment changes greater than 0.5 mm or bundle-branch block, new or presumed new or sustained ventricular tachycardia; cardiac markers - NSTEMI patients with elevated cardiac TnT, Tnl, or CK-MB. A percutaneous coronary intervention is necessary for a myocardial infarction that presents with ST segment elevation and the subject does not have recurrent or persistent symptoms, symptoms of heart failure or ventricular arrhythmia after a successful dose of thrombolytic therapy. A percutaneous coronary intervention is necessary for a myocardial infarction that presents with ST segment elevation and the subject does not have recurrent or persistent symptoms, symptoms of heart failure or ventricular arrhythmia. The presentation is past twelve hours since onset of symptoms. A percutaneous coronary intervention is necessary for a myocardial infarction that presents with ST segment elevation and the subject has recurrent or persistent symptoms, symptoms of heart failure or ventricular arrhythmia. The presentation is past twelve hours since onset of symptoms. A procedure to evaluate the health of the an individual after receiving a heart transplant. A procedure to evaluate the health of the cardiac system to determine feasibility of a non-cardiac related surgical procedure. A procedure performed to avoid the first occurrence of a disease condition. A percutaneous coronary intervention is imperative for a myocardial infarction that presents with ST segment elevation after an unsatisfactory response to a full dose of thrombolytic therapy.

NCI Preferred Term Percutaneous Coronary Intervention for High Risk Non-ST Elevation Myocardial Infarction or Unstable Angina

C100001

Percutaneous Coronary Intervention (PCI) for St Elevation Myocardial Infarction (STEMI) (Stable After Successful Full-Dose Thrombolytics) Percutaneous Coronary Intervention (PCI) for St Elevation Myocardial Infarction (STEMI) (Stable, >12 Hrs From Symptom Onset) Percutaneous Coronary Intervention (PCI) for St Elevation Myocardial Infarction (STEMI) (Unstable, >12 Hrs From Symptom Onset) Post-Cardiac Transplant Pre-Operative Evaluation for Non-Cardiovascular Surgery Primary Prevention Rescue Percutaneous Coronary Intervention (PCI) for St Elevation Myocardial Infarction (STEMI) (After Failed Full-Dose Thrombolytics) Secondary Prevention Spontaneous Sustained Ventricular Tachycardia

Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction - Stable After Successful Full-Dose Thrombolytic Therapy

C100000

Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction - Stable - Over 12 Hours From Symptom Onset

C100002

Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction - Unstable - Over 12 Hours From Symptom Onset

C100005 C100006

Post-Cardiac Transplant Evaluation Pre-Operative Evaluation for Non-Cardiovascular Surgery Primary Prevention Rescue Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction After Failed Full-Dose Thrombolytic Therapy

C15306 C100008

C15712 C100014

A procedure performed to avoid a subsequent occurrence of a disease condition. Ventricular tachycardia that occurs without provocation and does not resolve spontaneously.

Secondary Prevention Spontaneous Sustained Ventricular Tachycardia

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CDISC SDTM Controlled Terminology, 2012-06-29


C101846 - CVPRCIND - Cardiac Procedure Indication Codelist extensible: Yes
CDISC Synonym

NCI Code C100015

CDISC Submission Value Staged Percutaneous Coronary Intervention (PCI)

CDISC Definition A subsequent Percutaneous Coronary Intervention in a planned series of procedures, where the first PCI could have been during a prior admission, or during this admission. A sudden loss of consciousness with loss of postural tone not related to anesthesia with high risk characteristics. High risk characteristics include non-ischemic dilated cardiomyopathy, or ischemic heart disease with significant ventricular dysfunction, hypertrophic cardiomyopathy, Brugada Syndrome, or Long QT Syndrome. Sudden loss of consciousness with loss of postural tone not related to anesthesia with ventricular tachycardia (VT) that can be induced during an electrophysiological study. Not known, not observed, not recorded, or refused. (NCI) A device with additional pacing capabilities is replacing the current device. Ventricular Fibrillation is characterized by rapid, usually more than 300 bpm (cycle length: 180 ms or less), grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude.

NCI Preferred Term Staged Percutaneous Coronary Intervention

C100018

Syncope with High Risk Characteristics

Syncope with High Risk Cardiac Characteristics

C100019

Syncope with Inducible Ventricular Tachycardia

Syncope with Inducible Ventricular Tachycardia

C17998 C100030 C50799

Unknown Upgrade to a Device with Additional Pacing Capabilities Ventricular Fibrillation

Unknown Upgrade to Cardiac Device with Additional Pacing Capabilities Ventricular Fibrillation

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CDISC SDTM Controlled Terminology, 2012-06-29


C101847 - CVSLDEXT - Coronary Vessel Disease Extent Codelist extensible: No
CDISC Synonym

NCI Code C48658 C99993 C99997

CDISC Submission Value INDETERMINATE NO DISEASE ONE VESSEL DISEASE

CDISC Definition Cannot distinguish between two or more possible values in the current context. (NCI) There was less than 50% stenosis (reduction in cross-sectional area) in all coronary artery branches. There was greater than or equal to 50% stenosis (reduction in cross-sectional area) in one coronary artery. There was greater than or equal to 50% stenosis (reduction in cross-sectional area) in three coronary arteries (or greater than or equal to 50% stenosis in the left main coronary artery and greater than or equal to 50% stenosis in the right coronary artery). There was greater than or equal to 50% stenosis (reduction in cross-sectional area) in two coronary arteries (or greater than or equal to 50% stenosis in the left main coronary artery). Not known, not observed, not recorded, or refused. (NCI)

NCI Preferred Term Indeterminate No Evidence of Coronary Artery Disease One Coronary Vessel Disease

C100020

THREE VESSEL DISEASE

Three Vessel Coronary Disease

C100023

TWO VESSEL DISEASE

Two Vessel Coronary Disease

C17998

UNKNOWN

Unknown

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CDISC SDTM Controlled Terminology, 2012-06-29


C78731 - DATEST - Drug Accountability Test Name Codelist extensible: Yes
CDISC Synonym Dispensed Amount Returned Amount

NCI Code C78721 C78722

CDISC Submission Value Dispensed Amount Returned Amount

CDISC Definition The quantity of a product that has been dispensed. (NCI) The quantity of a product that has been returned. (NCI)

NCI Preferred Term Dispensed Amount Returned Amount

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CDISC SDTM Controlled Terminology, 2012-06-29


C78732 - DATESTCD - Drug Accountability Test Code Codelist extensible: Yes
CDISC Synonym Dispensed Amount Returned Amount

NCI Code C78721 C78722

CDISC Submission Value DISPAMT RETAMT

CDISC Definition The quantity of a product that has been dispensed. (NCI) The quantity of a product that has been returned. (NCI)

NCI Preferred Term Dispensed Amount Returned Amount

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CDISC SDTM Controlled Terminology, 2012-06-29


C101848 - DIABTHPY - Diabetes Therapy Codelist extensible: Yes
CDISC Synonym

NCI Code C15383 C2271 C99994 C102246

CDISC Submission Value DIET INSULIN NO TREATMENT ORAL MEDICATION

CDISC Definition A form of therapy which includes dietary approaches and special diets. A synthetic or animal-derived form of insulin used in the treatment of diabetes mellitus. No treatment for diabetes. A pharmacological medication intended for administration through the mouth.

NCI Preferred Term Special Diet Therapy Insulin No Treatment for Diabetes Oral Medication

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CDISC SDTM Controlled Terminology, 2012-06-29


C66788 - DICTNAM - Dictionary Name Codelist extensible: Yes
CDISC Synonym Coding Symbols for a Thesaurus of Adverse Reaction Terms International Classification of Diseases

NCI Code C49471

CDISC Submission Value COSTART

CDISC Definition A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI)

NCI Preferred Term Thesaurus of Adverse Reaction Term Coding Symbols

C49474

ICD

International Classification of Diseases

C49476

LOINC

Logical Observation Identifiers Names and Codes Medical Dictionary for Regulatory Activities

Logical Observation Identifiers Names and Codes

C43820

MedDRA

MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI) A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI)

MedDRA

C53489

SNOMED

Systematized Nomenclature of Medicine World Health Organization Adverse Reaction Terms World Health Organization Drug Dictionary

Systematized Nomenclature of Medicine World Health Organization Adverse Reaction Terminology

C49468

WHOART

C49475

WHODD

World Health Organization Drug Dictionary

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 45 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99074 - DIR - Directionality Codelist extensible: Yes
CDISC Synonym

NCI Code C25231 C25423 C90067 C73851 C25445 C37936 C25240 C25237 C45874 C90376 C90386 C90393 C25353 C37980 C73705 C25309 C25232 C81170 C38166 C25233 C25622 C25236 C94393 C25239 C25235 C25245 C90069 C25355 C45875 C98798

CDISC Submission Value ANTERIOR APICAL BASAL CAUDAL CENTRAL CRANIAL DEEP DISTAL DORSAL DORSOLATERAL FORE HIND INFERIOR INNER INTERMEDIATE LOWER MEDIAL MIDLINE OUTER PERIPHERAL POSTERIOR PROXIMAL ROSTRAL SUPERFICIAL SUPERIOR SURFACE TIP UPPER VENTRAL VENTROLATERAL

CDISC Definition Denoting the front portion of the body or a structure. Relating to or located at the apex. Relating to or located at the lowest portion of a structure. Toward the tail in a body. A point or area that is approximately central within some larger region or structure. (NCI) Toward the head in a body. Extending relatively far inward. (NCI) Situated farthest from a point of reference. Pertaining to the back or upper surface of the body. Toward the back and side of a body. Of or involving the front of a main body. (NCI) Of or involving the back of a main body. (NCI) Pertaining to a point below a given reference point. Inside or closer to the inside of the body or object. (NCI) Located between two points or extremes. The bottom one of two. (NCI) Toward the middle or in a limb toward the median plane. A medial line, especially the medial line or medial plane of the body (or some part of the body). Being on or toward the outside of the body or object. (NCI) On or near an edge or constituting an outer boundary; the outer area. (NCI) Denoting the back portion of the body or a structure. Situated nearest to a point of reference. Toward the muzzle in the head. Of or pertaining to the exterior surface. (NCI) Pertaining to a point above a given reference point. The extended two-dimensional outer layer or area of a three-dimensional object. (NCI) The pointed end of a structure. The top one of two. Pertaining to the front or lower surface of the body. Of or pertaining to the front and side of a main body. (NCI)

NCI Preferred Term Anterior Apical Basal Caudal Center Cranial Deep Distal Dorsal Dorsolateral Fore Hind Inferior Inner Intermediate Lower Medial Midline Outer Peripheral Posterior Proximal Rostral Superficial Superior Surface Tip Upper Ventral Ventrolateral

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 46 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101849 - DISCHDX - Discharge Disposition Codelist extensible: Yes
CDISC Synonym Died

NCI Code C28554 C99944

CDISC Submission Value Expired Expired in a Medical Facility

CDISC Definition The absence of life or state of being dead. (NCI) The patient died while in a medical center such as a hospital, skilled nursing facility (SNF), intermediate care facility (ICF), or a freestanding hospice center. The patient will be admitted to a medical center that is funded by the federal government (e.g. Veterans Affairs Hospital). The patient will return home but personal health maintenance will be administered and monitored by a member of a healthcare organization that is eligible to receive Medicare funding. The patient will receive end-of-life care which will be administered in the patient's home. A routine discharge where personal health maintenance will be administered and monitored by the patient from their home. The patient will receive end-of-life care which will be administered in a medical center. The patient will be admitted into a medical center and receive a type of hospital bed that will be paid for my Medicare. The patient will be admitted full time into a free standing rehabilitation center or a rehabilitation center within a general medical facility. The patient will be admitted into an alternative facility not listed. The patient will be admitted into a medical center that provides care 24 hours per day. The patient vacated the medical center or ceased medical care contrary to the recommendation of a trained healthcare provider. The patient will be admitted into a Medicare funded medical center for a considerable length of time. The patient will be admitted into a medical center which is eligible to receive funding from Medicaid but not Medicare. The patient will be admitted into a free standing medical facility or a unit within a general medical facility used for the treatment of mental health disorders. The patient will remain in a basic hospital environment for a brief time. The patient will be admitted into a medical center equipped with a trained nursing staff that is eligible to receive Medicare funding. Death

NCI Preferred Term

Died in a Medical Facility

C99909

Federal Health Care Facility

Federal Health Care Facility

C99959

Home Under Care of Organized Home Health Service Organization in Anticipation of Covered Skilled Care Home, Hospice Home, Self Care

Home Under Care of Organized Home Health Service Organization in Anticipation of Covered Skilled Care

C99958 C99957

Home Hospice Home Care

C99910 C99960

Hospice - Medical Facility Hospital-based Medicare-approved Swing Bed Inpatient Rehabilitation Facility (IRF) Including Rehabilitation Distinct Part Units of a Hospital Institution Not Defined Intermediate Care Facility Left Against Medical Advice or Discontinued Care Medicare-certified Long Term Care Hospital (LTCH) Nursing Facility Certified Under Medicaid but Not Certified Under Medicare Psychiatric Hospital or a Psychiatric-distinct Part Unit of a Hospital Short Term General Hospital Skilled Nursing Facility (SNF) with Medicare Certification in Anticipation of Covered Skilled Care

Hospice Care at Medical Facility Hospital with Medicare Approved Swing Bed Inpatient Rehabilitation Facility Including Rehabilitation distinct Part Units of a Hospital Institution Not Defined Intermediate Care Facility Left Against Medical Advice

C99911

C102247 C99912 C99969

C99984 C99913

Medicare Certified Long Term Care Hospital Nursing Facility Certified Under Medicaid but Not Certified Under Medicare Psychiatric Facility

C53536

C102248 C99914

Short Term General Hospital Skilled Nursing Facility with Medicare Certification in Anticipation of Covered Skilled Care

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 47 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes
CDISC Synonym Analysis Dataset

NCI Code C49563

CDISC Submission Value AD

CDISC Definition Datasets used for statistical analysis and reporting by the sponsor. These are submitted in addition to the data tabulation datasets. Adverse events may be captured either as free text or a pre-specified list of terms. Additional data about deaths, specific to findings from autopsies. Body weight gain is the actual difference between two body weight measurements for any given interval for a subject. This is most commonly shown as the difference between two consecutive body weight measurements. This domain captures behavioral testing measurements on individual subjects. Findings resulting from evaluations of bone mineral density. Findings resulting from biopsies. This domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights). A dataset used to capture clinical events of interest that would not be classified as adverse events. This domain captures clinical sign information including ophthalmology, physical examination, and dermal examination collected in life while executing the study. Case report form (CRF) data that captures the Concomitant and Prior Medications/Therapies used by the subject. Examples are the Concomitant Medications/Therapies given on an as needed basis and the usual Background Medications/Therapies given for a condition. The Comments dataset accommodates two sources of comments: 1) those collected alongside other data on topical case report form (CRF) pages such as Adverse Events and 2) those collected on a separate page specifically dedicated to comments. Data regarding the accountability of study drug, such as information on the receipt, dispensing, return, and packaging. Data related to the characteristics of a specific disease state under study for a subject. This domain captures the diagnosis of the cause of death for a subject. The Demographics domain includes a set of essential standard variables that describe each subject in a clinical study. It is the parent domain for all other observations for human clinical subjects

NCI Preferred Term Analysis Dataset Domain

C49562 C49565 C95083

AE AU BG

Adverse Events Autopsy Body Weight Gain

Adverse Event Domain Autopsy Domain Body Weight Gain Domain

C95084 C49566 C49567 C95085

BH BM BR BW

Behavioral Bone Measurements Biopsy Body Weight

Behavioral Domain Bone Measurements Domain Biopsy Domain Body Weight Domain

C85441 C95086

CE CL

Clinical Events Clinical Observation

Clinical Events Domain Clinical Observation Domain

C49568

CM

Concomitant Meds

Concomitant Medication Domain

C49569

CO

Comments

Comment Domain

C49578

DA

Drug Accountability Disease Characteristics Death Diagnosis Demographics

Drug Accountability Domain

C49570 C95087 C49572

DC DD DM

Disease Characteristics Domain Death Diagnosis Domain Demographics Domain

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CDISC SDTM Controlled Terminology, 2012-06-29


C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes
CDISC Synonym Developmental Milestone Disposition

NCI Code C95088

CDISC Submission Value DP

CDISC Definition This domain captures the outcome of developmental milestone testing during a scheduled period of observation. A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to disposition. (NCI) The intent of the domain is to capture protocol violations and deviations during the course of the study and will store only those criteria violation by or deviated from by the subject and not a response to each violation or deviation. Findings resulting from electroencephalogram (EEG) tests. Findings related to the collection of ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived. The Exposure domain model records the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. A dataset used to capture the findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier. This domain captures test results relative to male and female fertility. A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to family history. (NCI) This domain captures food/water consumption of animals in the study. The data in this domain is derived data. This domain captures observations for fetal and pup morphological examinations.

NCI Preferred Term Developmental Milestone Domain

C49576

DS

Disposition Domain

C49585

DV

Protocol Deviations

Protocol Deviations Domain

C49625 C49626

EE EG

Electroencephal ogram Electrocardiogra m

Electroencephalogram Domain Electrocardiogram Domain

C49587

EX

Exposure

Exposure Domain

C85442

FA

Findings About Events or Interventions Fertility Family History

Findings About Events or Interventions Domain Fertility Domain Family History Domain

C95089 C49588

FE FH

C95090

FW

Food And Water

Food and Water Consumption Domain Fetal and Neonatal Developmental Morphology Domain

C95091

FX

Fetal and Neonatal Developmental Morphology Healthcare Resource Utilization Implantation Classification Inclusion/ Exclusion

C49589

HU

Healthcare resource utilization data such as subject visits to physicians, hospitalizations, and nursing home stays. The Implantation Classification domain provides a record for each implantation identified for the scheduled cesarean section component of a study. The intent of the domain model is to only collect those criteria that cause the subject to be in violation of the inclusion/exclusion criteria not a response to each criterion.

Healthcare Resource Utilization Domain Implantation Classification Domain

C95092

IC

C61536

IE

Inclusion Exclusion Domain

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CDISC SDTM Controlled Terminology, 2012-06-29


C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes
CDISC Synonym Laboratory Data

NCI Code C49592

CDISC Submission Value LB

CDISC Definition Laboratory test findings including, but is not limited to hematology, clinical chemistry and urinalysis data. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. This domain captures litter based results in female animals for cesarean section and/or delivery components of a study, including litter survival during preweaning. The gross pathology findings recorded at necropsy. Microbiology specimen findings, including gram stain results, and organisms found. The medical history dataset includes the subject's prior history at the start of the trial. Examples of subject medical history information could include general medical history, gynecological history, and primary diagnosis. The histopathology findings and microscopic evaluations recorded. Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for pharmacokinetic analysis. This includes microbiology susceptibility test results, plus results of any other organism-related tests. Findings from organ measurement evaluations. Concentrations of drugs/metabolites in fluids or tissues as a function of time. Findings collected during a physical examination of the subject. It has findings that are discovered that are related to body systems. Does not include vital signs measurements, which are stored in the vital signs domain. Pharmacogenomics findings that initially focus on genotype and gene expression data. This domain captures information of any palpable masses examined during the experimental phase. Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. Questionnaire data may include, but are not limited to the following: subject reported outcomes, validated or non-validated questionnaires, and validated or non-validated diaries (i.e. data with a common topicality). The subject characteristics domain is for data not collected in other domains that is subject-related.

NCI Preferred Term Laboratory Data Domain

C95093

LR

Cesarean Section and Delivery Litter Results Macroscopic Findings Microbiology Medical History

Cesarean Section and Delivery Litter Results Domain

C95094 C49602 C49603

MA MB MH

Macroscopic Findings Domain Microbiology Specimen Domain Medical History Domain

C95095 C49604

MI ML

Microscopic Findings Meal Data

Microscopic Findings Domain Meal Data Domain

C61531 C49605 C49606 C49608

MS OM PC PE

Microbiology Susceptibility Organ Measurements Pharmacokinetic Concentration Physical Exam

Microbiology Susceptibility Domain Organ Measurement Domain Pharmacokinetic Concentration Domain Physical Exam Domain

C61529 C95097 C49607 C49609

PG PM PP QS

Pharmacogenomi cs Palpable Masses Pharmacokinetic Parameters Questionnaires

Pharmacogenomics Domain Palpable Masses Domain Pharmacokinetic Parameters Domain Questionnaire Domain

C49610

SC

Subject Characteristics

Subject Characteristics Domain

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CDISC SDTM Controlled Terminology, 2012-06-29


C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes
CDISC Synonym Subject Element

NCI Code C49616

CDISC Submission Value SE

CDISC Definition The subject element table describes the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. Surgical information. The Subject Stages domain captures subject level non-treatment related blocks of time known as stages, such as Gestation, Lactation and Premating. Findings from diagnostic skin tests. Findings from diagnostic sleep tests (polysomnography). Findings from exercise stress tests. The intent of the domain is to capture substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use. The subject visits table describes the actual start and end data/time for each visit of each individual subject. The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements. The trial elements table describes the element code that is unique for each element, the element description, and the rules for starting and ending an element. This domain captures the tumor findings of the nonclinical subject. The trial summary information domain is not subject oriented. It contains one record for each of the inclusion and exclusion criteria for the trial. The trial paths domain is not subject oriented. This domain provides the complete planned non-treatment related sequences of stages for each path in a study. The trial summary information domain is not subject oriented. It contains one record for each trial summary characteristic. The trial stages domain is not subject oriented. It captures non-treatment related planned blocks of time known as stages, such as Gestation, Lactation and Premating. The trial visits table describes the planned order and number of visits in the study within each arm.

NCI Preferred Term Subject Element Domain

C49611 C95099

SG SJ

Surgery Subject Stages

Surgery Domain Subject Stages Domain

C49612 C49613

SK SL

Skin Test Sleep Polysomnograph y Data Stress (Exercise) Test Data Substance Use

Skin Test Domain Sleep Polysomnography Domain

C49614 C49615

ST SU

Stress Exercise Test Data Domain Substance Use Domain

C49617 C49618

SV TA

Subject Visits Trial Arms

Subject Visits Domain Trial Arms Domain

C49619

TE

Trial Elements

Trial Elements Domain

C95100 C49620

TF TI

Tumor Findings Trial Inclusion/ Exclusion Criteria Trial Paths

Tumor Findings Domain Trial Inclusion and Exclusion Criteria Domain

C95101

TP

Trial Paths Domain

C53483

TS

Trial Summary

Trial Summary Domain

C95102

TT

Trial Stages

Trial Stages Domain

C49621

TV

Trial Visits

Trial Visits Domain

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 51 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes
CDISC Synonym Trial Sets

NCI Code C95103

CDISC Submission Value TX

CDISC Definition The trial stages domain is not subject oriented. It contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight.

NCI Preferred Term Trial Sets Domain

C49622

VS

Vital Signs

Vital Signs Domain

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 52 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74558 - DSCAT - Category for Disposition Event Codelist extensible: Yes
CDISC Synonym Disposition Event

NCI Code C74590

CDISC Submission Value DISPOSITION EVENT

CDISC Definition The group of incidents that occur during a clinical trial and describe whether a subject completed the study epoch or the reason this event did not occur. The subject's disposition is often described for each phase of the study. Other important events that occur during a trial but are not driven by protocol requirements. Occurrences within some epochs that are initiated by a protocol-specified event. The most common protocol milestone is "Informed Consent Obtained" which usually documents the start of the study.

NCI Preferred Term Protocol Disposition Event

C74589 C74588

OTHER EVENT PROTOCOL MILESTONE

Other Event Protocol Milestone

Protocol Event Protocol Milestone

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 53 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C90013 - EGLEAD - ECG Lead Codelist extensible: Yes
CDISC Synonym

NCI Code C90404

CDISC Submission Value LEAD CM5

CDISC Definition A bipolar EKG lead with the right thoracic limb electrode placed on the manubrium and left thoracic limb electrode placed at the surface marking of the V5 position (just above the 5th interspace in the anterior axillary line). The left pelvic limb lead acts as a neutral and may be placed anywhere. The C refers to 'clavicle' where it is often placed. (NCI) A unipolar chest lead used mostly in large animals. Placed on the sixth ICS on the right side of the thorax along a line parallel to the level of the point of the humeralradial joint. V1 electrode (+) placed in the 6th intercostal space on the left side of the thorax along a line parallel to the level of the point of the humeralradial joint. V2 electrode (+) placed in the 6th intercostal space on the left side of the thorax along a line parallel to the level of the point of the shoulder. (NCI) A bipolar electrocardiogram limb lead which records the voltage between the negative electrode on the right thoracic limb and the positive electrode on the left thoracic limb. (NCI) A bipolar electrocardiogram limb lead which records the voltage between the negative electrode on the right thoracic limb and the positive electrode on the left pelvic limb. (NCI) A bipolar electrocardiogram limb lead which records the voltage between the negative electrode on the left thoracic limb and the positive electrode on the left pelvic limb. (NCI) A unipolar electrocardiogram lead site; the electrode is placed at the fourth intercostal space on the anterior chest wall (between ribs 4 and 5) to the right of the sternal border. In small animals, it is placed at the right fifth intercostal space near the sternum. (NCI) A unipolar chest lead at which the electrode is placed over the dorsal spinous process of 7th thoracic vertebra. (NCI) A unipolar electrocardiogram lead site; the electrode is placed on the anterior chest wall at the fourth intercostal space (between ribs 4 and 5) to the left of the sternal border. In small animals it corresponds to V2-V3 where it is placed at the 6th left intercostal space near the sternum. In large animals it is placed over the 6th rib at the level of the costochondral junction on the left side of the thorax. A unipolar electrocardiogram lead site; the electrode is placed on the anterior chest wall midway between leads V2 and V4. In large and small animals, it is placed over the dorsal spinous process of the 7th thoracic vertebra. (NCI)

NCI Preferred Term Lead Site CM5

C90405

LEAD CV5RL

Lead Site CV5RL

C90406

LEAD CV6LL

Lead Site CV6LL

C90407

LEAD CV6LU

Lead Site CV6LU

C90408

LEAD I

Lead Site I

C90409

LEAD II

Lead Site II

C90410

LEAD III

Lead Site III

C90412

LEAD V1

Lead Site V1

C90413

LEAD V10

Lead Site V10

C90414

LEAD V2

Lead Site V2

C90415

LEAD V3

Lead Site V3

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 54 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C90013 - EGLEAD - ECG Lead Codelist extensible: Yes
CDISC Synonym

NCI Code C90416

CDISC Submission Value LEAD V4

CDISC Definition A unipolar electrocardiogram lead site; the electrode is placed at the fifth intercostal space on the anterior chest wall (between ribs 5 and 6) at the left midclavicular line. In small animals it corresponds to V4-V6 where it is placed at the 6th left intercostal space near the costochondral junction. In large animals it is placed over the 6th rib at the level of a horizontal line drawn through the scapulohumeral articulation on the left side of the thorax. (NCI) A unipolar electrocardiogram lead site; the electrode is placed on the anterior chest wall level with lead V4 at the left anterior axillary line. In large animals it is placed on the sixth ICS on the right side of the thorax along a line parallel to the level of the point of the shoulder corresponding to the electrical center of the heart (central terminal). (NCI) A unipolar electrocardiogram lead site at which the electrode is placed on the anterior chest wall level with lead V5 at the left midaxillary line . An augmented unipolar lead placed at the sixth intercostal space on the midaxillary line. (NCI) An augmented unipolar electrocardiogram limb lead in which the positive (red) electrode is situated on the left pelvic limb and the negative electrode is a combination of the right thoracic limb (white) electrode and the left thoracic limb (black) electrode. Measures the electrical activity of the electrode on the left pelvic limb. An augmented unipolar electrocardiogram limb lead in which the positive (black) electrode is situated on the left thoracic limb and the negative electrode is a combination of the right thoracic limb (white) electrode and the left pelvic limb (red) electrode. Measures the electrical activity of the electrode on the left thoracic limb. (NCI) An augmented unipolar electrocardiogram limb lead in which the positive (white) electrode is situated on the right thoracic limb and the negative electrode is a combination of the left thoracic limb (black) electrode and the left pelvic limb (red) electrode. Measures the electrical activity of the electrode on the right thoracic limb. (NCI) A unipolar precordial lead placed at the second intercostal space to the left of the sternum. (NCI)

NCI Preferred Term Lead Site V4

C90417

LEAD V5

Lead Site V5

C90418

LEAD V6

Lead Site V6

C90403 C90360

LEAD aV6 LEAD aVF

Lead Site aV6 Augmented Vector Foot

C90361

LEAD aVL

Augmented Vector Left

C90362

LEAD aVR

Augmented Vector Right

C90411

LEAD rV2

Lead Site rV2

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 55 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71151 - EGMETHOD - ECG Test Method Codelist extensible: Yes
CDISC Synonym 10 Lead Standard

NCI Code C90349

CDISC Submission Value 10 LEAD STANDARD

CDISC Definition An electrocardiogram lead placement on the subject using a ten electrode lead set to synthesize standard 12 lead electrocardiograph data to elicit an electrical view of the heart. An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but one standard lead position is missing therefore requiring a Mortara source consistency filter. (NCI) An electrocardiogram (ECG) lead placement whereby the display of the 12 standard ECG leads is in an orderly sequence in a single horizontal display of: aVL, I, -aVR, II, aVF, III, V1 to V6. In the Cabrera display the limb lead aVR is inverted (-aVR) to obtain the same positive leftward orientation as the other 5 limbs. (NCI) An electrocardiogram (ECG) lead placement whereby 4 chest electrodes and 1 reference electrode are used to allow for continuous monitoring at the clinical level. This placement creates a 12 lead ECG that allows the acquisition of simultaneous events in the frontal, horizontal and sagittal heart planes with the linear transformation of vectors. This system provides a three-dimensional portrayal of the heart and uses mathematical and fixed coefficients for each lead. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the standard lead positions have been modified for ECG recording during exercise. Exercise stress testing requires moving the limb electrodes to more central positions on the thorax. The electrodes are placed in bony prominences close to the bases of the respective limbs in order to avoid skeletal muscle artifact, provide stability for recording electrodes and to record waveforms similar to the standard limb sites. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the Mason Likar lead positions have been modified so that V1 to V6 on the chest are part of a single electrode pad. In addition, lead CM5 is substituted for lead aVR. (NCI) An electrocardiogram (ECG) lead placement whereby the limb leads are placed on the torso for easier and faster application in emergency situations. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the standard lead positions have been modified so that all leads on the chest are part of a single electrode pad. (NCI)

NCI Preferred Term 10 Lead Standard

C71125

12 LEAD 1 LEAD MISSING

12 Lead 1 Lead Missing

12 Lead Placement 1 Lead Missing

C71116

12 LEAD CABRERA

12 Lead Cabrera

12 Lead Placement Cabrera

C71123

12 LEAD EASI DOWER TRANSFORMATION

12 Lead EASI Dower Transformation

Lead Placement EASI Dower Transformation

C71103

12 LEAD MASON LIKAR

12 Lead Mason Likar

12 Lead Placement Mason Likar

C71110

12 LEAD MODIFIED MASON LIKAR

12 Lead Modified Mason Likar

12 Lead Placement Mason Likar Modified

C71114

12 LEAD NON-STANDARD

12 Lead Non-Standard 12 Lead Single Pad

12 Lead Placement Non-Standard

C71112

12 LEAD SINGLE PAD

12 Lead Placement Chest

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 56 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71151 - EGMETHOD - ECG Test Method Codelist extensible: Yes
CDISC Synonym 12 Lead Standard

NCI Code C71102

CDISC Submission Value 12 LEAD STANDARD

CDISC Definition An electrocardiogram (ECG) lead placement whereby 12 leads are recorded, with each lead representing an electrical view of the heart. The six leads recorded in the frontal plane are derived from the placement of 3 electrodes (RA or Right Arm, LA, or Left Arm, and LL or Left Leg). These bipolar frontal leads form the basis of Einthoven's triangle, and are represented by leads I, II, and III. Three other derived (or augmented) bipolar frontal vectors are also recorded on a standard 12-lead EKG, aVR, aVF, and aVL. 6 unipolar leads, corresponding to V1 - V6 measure the electrical activity in the horizontal plane. The placement for the V leads is as follows: V1: right 4th intercostal space,V2: left 4th intercostal space, V3: halfway between V2 and V4, V4: left 5th intercostal space, mid-clavicular line, V5: horizontal to V4, anterior axillary line, V6: horizontal to V5, mid-axillary line. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the position of the leads is unspecified. (NCI) An electrocardiogram lead placement on the subject using a six electrode lead set with three standard leads and three augmented derived leads to elicit an electrical view of the heart. An electrocardiogram (ECG) lead placement whereby the X+ lead is placed at the right mid-axillary line ate the 4th intercostal space, X- at the left mid-axillary line at he 4th intercostal space, Y+ at the proximal left leg, Y- at the superior aspect of the manubrium, Z+ at the direct posterior to Z- and Z- at the 4th intercostal space at the left sternal margin. (NCI) An electrocardiogram (ECG) lead placement that is a type of uncorrected vectorcardiograph. This lead system is based on a rectangular body axis. It uses an extra number of electrodes to make it three-dimensional. (NCI) An electrocardiogram (ECG) lead placement for determining 3 orthogonal components X (right to left direction), Y (foot to head direction) and Z (back to front direction) of the heart. For this method a minimum of 4 electrodes are needed that represent the right arm, left arm, left leg and back. However, usually 7 electrodes are used to avoid dependence on the dipole location and facilitate interpretation. (NCI) An electrocardiogram (ECG) lead placement for determining 3 orthogonal components X (back to front), Y (right to left) and Z (foot to head) of the heart. This system places the electrodes closer to the heart to achieve better orthogonality and a homogeneous lead field. (NCI)

NCI Preferred Term 12 Lead Placement Standard

C71101

12 LEAD UNSPECIFIED

12 Lead Unspecified 6 Lead Standard

12 Lead Placement Unspecified

C90350

6 LEAD STANDARD

6 Lead Standard

C71121

BIPOLAR UNCORRECTED XYZ LEAD SYSTEM

Bipolar uncorrected XYZ lead system

Lead Placement Bipolar Uncorrected XYZ

C71120

CUBE LEAD SYSTEM

Cube lead system

Lead Placement Cube

C71118

FRANK LEAD SYSTEM

Frank lead system

Lead Placement Frank

C71119

MCFEE-PARUNGAO LEAD SYSTEM

McFee-Parungao lead system

Lead Placement McFee-Parungao

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 57 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71151 - EGMETHOD - ECG Test Method Codelist extensible: Yes
CDISC Synonym Pseudo-orthogon al XYZ lead system

NCI Code C71122

CDISC Submission Value PSEUDO-ORTHOGONAL XYZ LEAD SYSTEM

CDISC Definition An electrocardiogram (ECG) lead placement that allows monitoring and recording of cardiac electrical activity. A V1-type lead is used whose positive electrode is localized in the 4th intercostal space, 2.5cm from the sternum. Its negative electrode is placed below the left clavicle. An addition of lead V5 and aVF can be made to facilitate interpretation. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the standard lead positions have been modified so that the negative reference is at CM5 and the active electrode is at the left leg position. (NCI) An electrocardiogram (ECG) lead placement whereby 12 leadpoints are recorded but the standard lead positions have been modified so that the bipolar lead groups place the negative of the reference electrode over the manubrium (CM5), the right scapula (CB5), V5R (CC5) or on the forehead (CH5) and the active electrode at V5. (NCI) An electrocardiogram (ECG) lead placement whereby the standard lead placement is modified by having leads V7, V8 and V9. (NCI) An electrocardiogram (ECG) lead placement whereby the rightward oriented V leads progress from V1R, placed instead of the standard V2, to V6R. The V3 lead in the standard placement is replaced by V4R. (NCI) Limb leads on the back (shoulder and on the hips). (NCI)

NCI Preferred Term Lead Placement Pseudo Orthogonal XYZ

C71128

STANDARD 12-LEAD AND CC5-CM5-ML

Standard 12-lead and CC5-CM5-ML

12 Lead Placement Standard And CC5-CM5-ML

C71126

STANDARD 12-LEAD AND CM5-CC5-CH5

Standard 12-lead and CM5-CC5-CH5

12 Lead Placement Standard And CC5-CM5-CH5

C71131

STANDARD 12-LEAD EXTENDED LEFT

Standard 12-lead extended to the left by V7, V8, V9 Standard 12-lead extended to the right by V5R, V4R, V3R Standard leads for bicycle exercise. Limb leads on the back (shoulder and on the hips) Standard leads one intercostal space higher Vectorcardiograp h Corrected Vectorcardiograp h Uncorrected

12 Lead Placement Standard Extended Left

C71130

STANDARD 12-LEAD EXTENDED RIGHT

12 Lead Placement Standard Extended Right

C71115

STANDARD LEADS FOR BICYCLE EXERCISE

Lead Placement Bicycle

C71117

STANDARD LEADS ONE INTERCOSTAL SPACE HIGHER VECTORCARDIOGRAPH CORRECTED VECTORCARDIOGRAPH UNCORRECTED

An electrocardiographic lead placement schema in which the V leads are placed one intercostal space cephalad to the position they would have in the standard lead placement schema. (NCI) A recording of the electrical activity of the heart displayed in the form of a vector loop, corrected for anatomic inconsistencies. (NCI) A recording of the electrical activity of the heart displayed in the form of a vector loop, uncorrected for anatomic inconsistencies. (NCI)

Lead Placement Standard Intercostal Space Higher

C71092

Vectorcardiograph Corrected

C71093

Vectorcardiograph Uncorrected

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 58 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym 1st degree AV block

NCI Code C62015

CDISC Submission Value 1ST DEGREE AV BLOCK

CDISC Definition A delay in the time required for the conduction of an electrical impulse through the atrioventricular (AV) node beyond 0.2 seconds; prolongation of the PR interval beyond 200 milliseconds. (NCI) A electrocardiographic finding of an electrical phenomenon in which the ratio of electrical impulse generated above the atrioventricular node to the number of impulses conducted through to the ventricles is 2:1. (NCI) Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles. (NCI) Complete failure of atrial electrical impulse conduction through the AV node to the ventricles. (NCI) The term accelerated idioventricular rhythm describes an ectopic ventricular rhythm with 3 or more consecutive ventricular premature beats with a rate faster than the normal ventricular intrinsic escape rate of 30 to 40 beats per minute, but slower than ventricular tachycardia. Accelerated idioventricular rhythm differs from ventricular tachycardia by additional features such as the onset with a long coupling interval and the end by a gradual decrease of the ventricular rate or increase of the sinus rate. (NCI) Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the anterior wall of the heart. (NCI) Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the inferior wall of the heart. (NCI) Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the lateral wall of the heart. (NCI) Electrocardiographic finding showing a current of injury in leads corresponding to the anatomic region of the posterior wall of the heart. (NCI) A condition that occurs as a result of cAMP-mediated triggered activity and typically originates from the right ventricular outflow tract (RVOT). This type of tachycardia occurs in patients with apparently normal hearts. (NCI) Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the anterior wall of the heart. (NCI) An electrocardiographic finding which comprises left, right or bilateral atrial enlargement. (NCI)

NCI Preferred Term AV Block First Degree

C71044

2:1 AV BLOCK

2:1 AV block

2:1 Atrioventricular Block

C62016

2ND DEGREE AV BLOCK

2nd degree AV block 3rd degree AV block Accelerated idioventricular rhythm

AV Block Second Degree

C50501

3RD DEGREE AV BLOCK

AV Block Third Degree

C62266

ACCELERATED IDIOVENTRICULAR RHYTHM

Accelerated Idioventricular Rhythm

C71065

ACUTE ANTERIOR WALL MI

Acute Anterior Wall Myocardial Infarction

Acute Anterior Wall Myocardial Infarction Acute Inferior Wall Myocardial Infarction Acute Lateral Wall Myocardial Infarction Acute Posterior Wall Myocardial Infarction Adenosine-Sensitive Ventricular Tachycardia

C71066

ACUTE INFERIOR WALL MI Acute Inferior Wall Myocardial Infarction ACUTE LATERAL WALL MI Acute Lateral Wall Myocardial Infarction ACUTE POSTERIOR WALL MI ADENOSINE-SENSITIVE VENTRICULAR TACHYCARDIA Acute Posterior Wall Myocardial Infarction Adenosine-sensit ive ventricular tachycardia

C71067

C71068

C71057

C71069

ANTERIOR WALL MYOCARDIAL INFARCTION ATRIAL ENLARGEMENT

Anterior Wall Myocardial Infarction Atrial Enlargement

Anterior Wall Myocardial Infarction

C71039

EKG Finding Atrial Enlargement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 59 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Atrial fibrillation

NCI Code C50466

CDISC Submission Value ATRIAL FIBRILLATION

CDISC Definition A supraventricular arrhythmia characterized by uncoordinated atrial myocardium activation due to multiple reentry circuits with consequent deterioration of atrial mechanical function. Instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often tachycardia ventricular rate. On the ECG it is described by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape, and timing, associated with an irregular, frequently rapid ventricular response when atrioventricular conduction is intact. (NCI) An electrocardiographic finding of an organized rhythmic contraction of the atria which is generally at a rate of 200-300 beats per minute. (NCI) Any rapid heart rhythm originating in the atria. Atrial fibrillation and atrial flutter are varieties of atrial tachycardia. Atrial tachycardia is an electrical circuit originating in the upper or atrial chambers. This electrical circuit or focus takes over and generates rapid impulses across the atrial chambers. These impulses are transmitted to the ventricular chambers resulting in a rapid rate. These arrhythmias may originate from a variety of places across the atria. They may exist as an isolated problem or be related to an ongoing structural problem within the heart. (NCI) An electrocardiographic finding in which the electrical activity of the atria and ventricles are causally independent of one another. (NCI) Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a progressively lengthening PR interval prior to the block of an atrial impulse. Intermittent failure of atrial electrical impulse conduction through the atrioventricular (AV) node to the ventricles, characterized by a relatively constant PR interval prior to the block of an atrial impulse. A supraventricular tachycardia due to reentry along a circuit contained within the AV node. AVNRT is the most common form of supraventricular tachycardia and usually presents as a narrow QRS complex tachycardia at a rate between 150 and 250 beats per minute. (NCI) A supraventricular tachycardia due to reentry along a circuit including a concealed AV nodal bypass tract. This tachycardia circuit proceeds in an antegrade fashion through the AV node and then is conducted retrograde through the bypass tract into the atria. (NCI)

NCI Preferred Term Atrial Fibrillation

C51224

ATRIAL FLUTTER

Atrial flutter

Atrial Flutter

C35481

ATRIAL TACHYCARDIA

Atrial tachycardia

Atrial Tachycardia

C71045

ATRIOVENTRICULAR DISSOCIATION AV MOBITZ I

Atrioventricular dissociation AV Mobitz I

Atrioventricular Dissociation

C62017

AV Mobitz I

C62018

AV MOBITZ II

AV Mobitz II

AV Mobitz II

C35058

AV NODE RE-ENTRY

AV node re-entry

Atrioventricular Nodal Reentry Tachycardia

C62261

AV RE-ENTRANT TACHYCARDIA

AV re-entrant tachycardia

Atrioventricular Reentrant Tachycardia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 60 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Bifascicular block

NCI Code C71046

CDISC Submission Value BIFASCICULAR BLOCK

CDISC Definition An electrocardiographic finding comprising right bundle branch block and left anterior fascicular block, or right bundle branch block and left posterior fascicular block. Defects occurring in two of the three divisions of the conduction system of the heart are considered bifascicular blocks. Technically left bundle branch block may be considered a bifascicular block. (NCI) An electrocardiographic finding of a normal QRS followed by a premature ventricular contraction; a rhythmic pairing of normal and abnormal beats originating in the ventricles in a 1-1 ratio. (NCI) An electrocardiographic finding in which the QTcB is approximately 430-470 msec. There is variation among subpopulations. An electrocardiographic finding in which the QTcF is approximately 430-470 msec. There is variation among subpopulations. Non-sinus origin slow heart rate. An uncommon form of ventricular tachycardia (VT) incorporating both bundle branches into the reentry circuit. Surface electrocardiogram (ECG) of sinus rhythm (SR) characteristically shows intraventricular conduction defects. Patients typically present with presyncope, syncope or sudden death because of VT with fast rates frequently above 200 beats per minute. The QRS morphology during VT is a typical bundle branch block pattern, usually left bundle branch block, and may be identical to that in SR. (NCI) An initial slurring (delta wave) of the QRS complex due to the presence of an accessory pathway. This characteristic EKG pattern is typically seen in Wolff-Parkinson-White syndrome. (NCI) An electrocardiographic finding in which the amplitude of the R wave is abnormally increased in the anterior precordial leads. A cardiac rhythm resulting from either an abnormal electrical focus in the atria or intra-atrial reentry. Atrial ectopic beats (AEB) refer to a contraction of the upper heart chamber which occurs before it would be expected. Atrial ectopic beats are also known as premature atrial beats, premature atrial complex (PAC), or atrial extrasystole. (NCI) An electrocardiographic finding of a rhythm originating at a site other than the sinoatrial node, which is also above the atrioventricular node. (NCI) A cardiac rhythm resulting from either an abnormal electrical focus in the ventricle. Ventricular ectopic beats (VEB) refer to a contraction of the lower heart chamber which occurs before it would be expected. Ventricular ectopic beats are also known as premature ventricular beats, premature ventricular complex (PVC), or ventricular extrasystole. (NCI)

NCI Preferred Term Bifascicular Block

C71054

BIGEMINY

Bigeminy

Bigeminy

C92228

BORDERLINE QTcB

Borderline QTcB

Borderline QTcB

C92229

BORDERLINE QTcF

Borderline QTcF

Borderline QTcF

C37920 C71062

BRADYCARDIA BUNDLE BRANCH REENTRANT TACHYCARDIA

Bradycardia Bundle branch reentrant tachycardia

Bradycardia Bundle Branch Re-Entrant Ventricular Tachycardia

C62258

DELTA WAVE

Delta wave

EKG Delta Wave

C92230

EARLY R WAVE PROGRESSION

Early R Wave Progression

Early R Wave Progression

C62245

ECTOPIC ATRIAL RHYTHM Ectopic atrial rhythm

Ectopic Atrial Rhythm

C71043

ECTOPIC SUPRAVENTRICULAR RHYTHM ECTOPIC VENTRICULAR RHYTHM

Ectopic supraventricular rhythm Ectopic ventricular rhythm

Ectopic Supraventricular Rhythm

C71042

Ectopic Ventricular Rhythm

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 61 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Electrical alternans Fascicular tachycardia

NCI Code C71035

CDISC Submission Value ELECTRICAL ALTERNANS

CDISC Definition An electrocardiographic finding in which there is an alternating pattern of any of the waveform components. (NCI) A distinct subgroup of idiopathic ventricular tachycardia (VT) that may be confused with either typical VT or supraventricular tachycardia (SVT). It is characterized by the absence of structural heart disease and classic electrocardiographic and electrophysiological features. It originates from the region of the posterior fascicle (or occasionally the anterior fascicle) of the left bundle branch and is partly propagated by the His-Purkinje network. It therefore produces QRS complexes of relatively short duration (0.11-0.14)s. (NCI) Idiopathic ventricular tachycardia (VT) is a type of ventricular tachycardia occurring unrelated to any organic cardiac disease. The abnormality is probably congenital, be it a focus of abnormal automaticity or myocardial tissue that can sustain re-entry. The clinical presentation for idiopathic VT can be very much like a paroxysmal supraventricular tachycardia. That is, most patients are generally younger without overt cardiac disease and present with paroxysmal palpitations. Idiopathic ventricular tachycardia is not generally life-threatening. (NCI) Inappropriate sinus tachycardia (IST) is a rare form of supraventricular tachycardia involving the sinus node, in which a patient has an abnormally high heart rate, occurring both at rest and in response to stressors (such as physical activity). (NCI) An electrocardiographic finding of bundle branch block which does not meet the criteria for a more specific bundle branch block. (NCI) An partial impairment of transmission of the cardiac electrical impulse along the fibers of the left bundle branch. (NCI) Various mechanisms may result in a pattern showing an incomplete right bundle branch block (RBBB). These include different degrees of conduction delay through the main trunk of the right bundle branch; increased conduction time through an elongated right bundle branch; diffuse Purkinje-myocardial delay due to right ventricular stretch or dilatation; surgical trauma or disease-related interruption of the major ramifications of the right branch (distal RBBB or right fascicular blocks); congenital variations of the distribution of the major ramifications resulting in a slight delay in the activation of the crista supraventricularis. (NCI) Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the inferior wall of the heart. (NCI) A delay in impulse propagation through the atria. (NCI)

NCI Preferred Term Electrical Alternans

C71061

FASCICULAR TACHYCARDIA

Fascicular Tachycardia

C71063

IDIOPATHIC RIGHT BUNDLE BRANCH BLOCK VENTRICULAR TACHYCARDIA

Idiopathic right bundle branch block ventricular tachycardia

Idiopathic Right Bundle Branch Block

C62253

INAPPROPRIATE SINUS TACHYCARDIA

Inappropriate sinus tachycardia

Inappropriate Sinus Tachycardia

C71049

INCOMPLETE BUNDLE BRANCH BLOCK INCOMPLETE LEFT BUNDLE BRANCH BLOCK INCOMPLETE RIGHT BUNDLE BRANCH BLOCK

Incomplete bundle branch block Incomplete left bundle branch block Incomplete right bundle branch block

Incomplete Bundle Branch Block

C71047

Incomplete Left Bundle Branch Block Incomplete Right Bundle Branch Block

C71048

C35398

INFERIOR WALL MYOCARDIAL INFARCTION INTRAATRIAL CONDUCTION DELAY

Inferior Wall Myocardial Infarction Intraatrial Conduction Delay

Inferior Wall Myocardial Infarction

C71073

Intra-Atrial Conduction Delay

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 62 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Intraventricular conduction delay, nonspecific

NCI Code C62271

CDISC Submission Value INTRAVENTRICULAR CONDUCTION DELAY, NONSPECIFIC

CDISC Definition A delay in transmission of cardiac electrical impulses in the His-Purkinje system, diagnosed when the QRS is modestly prolonged (< 120 msec) and the QRS pattern and axis are not typical of a hemiblock. The conduction delay is considered to occur beyond the Purkinje's myocardial gates and arises from slow cell-to-cell conduction. The phenomenon is common in patients with acute MI. (NCI) A type of atrioventricular dissociation characterized by atria and ventricles beating at similar rates, although independently. (NCI) Elevation of the J point above the baseline; the J point represents the end of ventricular depolarization and located at the terminus of the QRS complex. (NCI) An electrocardiographic finding in which the pacer of the heart is located in the AV junction, normally presenting with a narrow QRS complex at a rate less than 60 beats per minute. (NCI) An electrocardiographic finding in which the pacer of the heart is located in the AV junction, normally presenting with a narrow QRS complex and a rate of 60-100 beats per minute. (NCI) An automatic tachycardia originating in the atrioventricular junction, typically arising in the conduction tissues surrounding the atrioventricular node. A junctional tachycardia tends to be a regular, narrow complex tachycardia and usually occurs during myocardial infarction, after heart surgery, or in digitalis intoxication. The rate may range from 140 to 250 beats per minute. (NCI) Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the lateral wall of the heart. (NCI) An impairment of transmission of the cardiac electrical impulse along the fibers of the left anterior fascicle. In left anterior fascicular block (LAFB) the posteroinferior regions of the left ventricular endocardium are activated abnormally before the anterosuperior left ventricular area. After emerging from the posteroinferior division of the left bundle branch, the impulse first propagates in an inferior, rightward, and usually anterior direction for a short period of time. This orientation is responsible for the small Q waves in leads 1 and aVL and for the R waves in leads II, III, and aVF. (NCI) An electrocardiographic finding suggesting underlying hypertrophy or dilatation of the left atrium. Electrocardiographic criteria used for the diagnosis of left atrial abnormality may include a bifid p wave, a biphasic p wave and/or a p wave duration of greater than 0.12 seconds. (NCI)

NCI Preferred Term Nonspecific Intraventricular Conduction Delay

C62248

ISORHYTHMIC DISSOCIATION J POINT ELEVATION

Isorhythmic dissociation J point elevation

Isorhythmic Atrioventricular Dissociation J Point Elevation

C71030

C71074

JUNCTIONAL BRADYCARDIA

Junctional bradycardia

Junctional Bradycardia

C71051

JUNCTIONAL RHYTHM

Junctional rhythm

Junctional Rhythm

C35059

JUNCTIONAL TACHYCARDIA

Junctional tachycardia

Junctional Tachycardia

C35586

LATERAL WALL MYOCARDIAL INFARCTION LEFT ANTERIOR FASCICULAR BLOCK

Lateral Wall Myocardial Infarction Left anterior fascicular block

Lateral Wall Myocardial Infarction

C62267

Left Anterior Fascicular Block

C71040

LEFT ATRIAL ENLARGEMENT

P-mitrale

P-mitrale

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 63 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Left bundle branch block

NCI Code C62269

CDISC Submission Value LEFT BUNDLE BRANCH BLOCK

CDISC Definition An impairment of transmission of the cardiac electrical impulse along the fibers of the left main bundle branch, or both the left anterior fascicle and left posterior fascicle. This conduction disturbance is characterized by wide (greater than 0.11s) QRS complexes. The diagnostic criteria consist of prolongation of the QRS complexes (over 0.11s) with neither a Q wave nor an S wave in lead V1 and in the properly placed V6. A wide R wave with a notch on its top (plateau) is seen in these leads. In hearts with an electrical (and anatomic) vertical position a small Q wave may be seen in AVL in the absence of MI. Right chest lead V1 may or may not show an initial R wave, but the latter should be present in lead V2. (NCI) An impairment of transmission of the cardiac electrical impulse along the fibers of the left posterior fascicle. In pure left posterior fascicular block (LPFB), the impulse emerges from the unblocked anterosuperior division, thus producing small q waves in leads II, III, and aVF. Thereafter, the impulse moves through the electrically predominant left ventricle in an inferior and rightward direction, thus explaining the S waves in leads I and aVL as well as the R waves in leads II, III, and aVF. (NCI) An electrocardiographic finding in which there is evidence that electrical transmission through the left ventricle is impaired. Electrocardiographic findings suggestive of a hypertrophic left ventricle. (NCI)

NCI Preferred Term Left Bundle Branch Block

C62268

LEFT POSTERIOR FASCICULAR BLOCK

Left posterior fascicular block

Left Posterior Fascicular Block

C92231

LEFT VENTRICULAR CONDUCTION DELAY LEFT VENTRICULAR HYPERTROPHY LOW QRS VOLTAGE

Left Ventricular Conduction Delay Left Ventricular Hypertrophy

Left Ventricular Conduction Delay

C71076 C71078

EKG Finding Left Ventricular Hypertrophy Low QRS Voltage

Low QRS voltage An electrocardiographic finding of a QRS amplitude less than or equal to 5mm in the limb leads or QRS amplitude less than or equal to 10mm in the precordial leads. (NCI) Multifocal atrial tachycardia An electrocardiographic finding in which the electrical axis of the p wave is variable and the rate is greater than 100 beats per minute. To meet criteria for multifocal atrial tachycardia, the p wave must exhibit three distinct morphologies on the rhythm strip. (NCI) A myocardial infarction in the absence of observable Q wave abnormalities in the ECG. (NCI) An electrocardiographic finding of changes in the ST segment and T wave that do not meet criteria for ischemia or infarction. (NCI) An electrocardiographic finding of ventricular tachycardia less than 30 seconds in duration. (NCI) Any depression occurring in a positive t wave. (NCI)

C71050

MULTIFOCAL ATRIAL TACHYCARDIA

Multifocal Atrial Tachycardia

C71080

NON Q WAVE MYOCARDIAL INFARCTION NON-SPECIFIC ST-T CHANGES NON-SUSTAINED VENTRICULAR TACHYCARDIA NOTCHED T-WAVES

Non Q Wave Myocardial Infarction Non-specific ST-T changes Non-sustained ventricular tachycardia Notched T-waves

Non Q Wave Myocardial Infarction

C71031

Non-Specific ST-T Changes

C71053

Non-Sustained Ventricular Tachycardia Notched T-Waves

C71032

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 64 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Outflow tract ventricular tachycardia

NCI Code C71064

CDISC Submission Value OUTFLOW TRACT VENTRICULAR TACHYCARDIA

CDISC Definition Right ventricular outflow tract tachycardia (RVOT) is the most common with a female predominance. It is often exercise induced or enhanced. The site of origin is the right ventricular outflow tract and hence the electrocardiographic appearance is that of left bundle branch block and inferior axis. The mechanism is thought to be abnormal automaticity that is sensitive to adenosine. (NCI) An electrocardiographic finding for the P wave that is atypical either for the shape, duration, amplitude, axis or polarity. Abnormality of the P wave signifies aberrant propagation of the electrical impulse through the atria. (NCI) P waves with two peaks longer in duration than normal and amplitude greater than normal. (NCI) An electrocardiographic finding in which both the atrial and ventricular rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the atrial rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the cardiac rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. An electrocardiographic finding in which the ventricular rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. Sudden onset AV block, often associated with preexisting conduction disorders. (NCI) An episodic form of ventricular tachycardia, with abrupt onset and termination. (NCI) Lack of progression of R wave height across precordial leads. (NCI) Electrocardiographic finding showing an injury in leads corresponding to the anatomic region of the posterior wall of the heart. (NCI) A PR interval of more than 0.20 seconds in adults. (NCI) A condition characterized by the activation of the whole or some part of the ventricle by the transmission of an atrial impulse along an accessory pathway rather than by way of the normal specific conduction system which includes a delay at the atrioventricular node. (NCI) Ectopic impulses originating in the atria. (NCI)

NCI Preferred Term Right Ventricular Outflow Tract Tachycardia

C90430

P WAVE ABNORMALITY

P Wave Abnormality

P Wave Abnormality

C90431 C92232

P WAVE NOTCHED PACED ATRIAL AND VENTRICULAR RHYTHM

P Wave Notched Paced Atrial And Ventricular Rhythm Paced Atrial Rhythm Paced Rhythm; Atrial and/or Ventricular Paced Rhythm Paced Ventricular Rhythm Paroxysmal AV block Paroxysmal Ventricular Tachycardia Poor R Wave Progression Posterior Wall Myocardial Infarction PR prolongation Pre-excitation

P Wave Notched Paced Atrial And Ventricular Rhythm

C92233

PACED ATRIAL RHYTHM

Paced Atrial Rhythm

C88140

PACED RHYTHM

Paced Rhythm

C92234

PACED VENTRICULAR RHYTHM PAROXYSMAL AV BLOCK PAROXYSMAL VENTRICULAR TACHYCARDIA POOR R WAVE PROGRESSION POSTERIOR WALL MYOCARDIAL INFARCTION PR PROLONGATION PRE-EXCITATION

Paced Ventricular Rhythm

C62250 C34902

Paroxysmal Atrioventricular Block Paroxysmal Ventricular Tachycardia

C71033 C71081

Poor R Wave Progression Posterior Wall Myocardial Infarction Prolonged PR Interval Pre-Excitation Syndrome

C62247 C34940

C62257

PREMATURE ATRIAL COMPLEXES

Premature atrial complexes

Atrial Premature Complex

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 65 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym PVC Prolonged QT Q Axis, Left axis deviation Q Axis, Right axis deviation QRS Complex Abnormality QRS Complex Absent QTcB prolongation >500 msec QTcF prolongation >500 msec R on T phenomenon

NCI Code C62256 C71034 C71094 C71095 C90440

CDISC Submission Value PREMATURE VENTRICULAR COMPLEX PROLONGED QT Q AXIS, LEFT AXIS DEVIATION Q AXIS, RIGHT AXIS DEVIATION QRS COMPLEX ABNORMALITY QRS COMPLEX ABSENT

CDISC Definition Ectopic impulses originating in the ventricles. (NCI) A QT interval that is prolonged. The length of the QT interval varies with the heart rate. (NCI) Q axis from -30 to -90 degrees. (NCI) Q axis from +90 to +180 degrees. (NCI) An electrocardiographic finding for the QRS complex that is atypical either for the shape, duration, amplitude, axis or polarity. (NCI) A disturbance in the depolarization of the ventricular myocardium which leads to an absence of the QRS complex in the electrocardiogram tracing. (NCI) Corrected QT interval longer than 500 msec, in accordance with Bazett's correction formula. (NCI) Corrected QT interval greater than 500 msec, in accordance with Fridericia's correction formula. (NCI) An electrocardiographic finding phenomena in which the R wave occurs on top of the T wave; this can trigger ventricular fibrillation or ventricular tachycardia. (NCI)

NCI Preferred Term Ventricular Premature Complex Prolonged QT Interval Q Axis Left Axis Deviation Q Axis Right Axis Deviation QRS Complex Abnormality

C90441

QRS Complex Absent

C71096

QTCB PROLONGATION >500 MSEC QTCF PROLONGATION >500 MSEC R ON T PHENOMENON

QTcB Prolongation Greater Than 500 msec QTcF Prolongation Greater Than 500 msec R On T Phenomenon

C71097

C61395

C90443

R WAVE ABNORMALITY

R Wave Abnormality

An abnormal R wave that is part of the QRS complex in R Wave Abnormality an electrocardiographic recording, which occurs due to a disturbance in the depolarization mechanism of the ventricular myocardium. (NCI) An R wave variant in which there is a small deflection of the R wave, with changing polarity, within the QRS complex. (NCI) The inherent change of a subject's heart rate associated with each excursion of breath, which can be traced in an electrocardiographic recording. (NCI) An electrocardiographic finding suggesting underlying hypertrophy or dilatation of the right atrium. Electrocardiographic criteria used for the diagnosis of right atrial abnormality may include a peaked p wave greater than 2.5 millimeters in amplitude in the inferior leads. (NCI) An impairment of transmission of the cardiac electrical impulse along the fibers of the right bundle branch. A "complete RBBB pattern" (with QRS duration > 0.11s) does not necessarily reflect the existence of a total conduction block in the right branch. This pattern only indicates that the entire or major parts of both ventricles are activated by the impulse emerging from the left branch. Thus, a significant degree of conduction delay ("high-grade" or "incomplete RBBB") can produce a similar pattern. (NCI) R Wave Notched

C90444

R WAVE NOTCHED

R Wave Notched

C90450

RESPIRATORY SINUS ARRHYTHMIA RIGHT ATRIAL ABNORMALITY

Respiratory Sinus Arrhythmia P-pulmonale

Respiratory Sinus Arrhythmia

C71041

P-pulmonale

C62270

RIGHT BUNDLE BRANCH BLOCK

Right Bundle Branch Block

Right Bundle Branch Block

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 66 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Right Ventricular Conduction Delay; Right Ventricular Delay Right ventricular Hypertrophy RSR'

NCI Code C92235

CDISC Submission Value RIGHT VENTRICULAR CONDUCTION DELAY

CDISC Definition An electrocardiographic finding in which there is evidence that electrical transmission through the right ventricle is impaired.

NCI Preferred Term Right Ventricular Conduction Delay

C71077 C92227

RIGHT VENTRICULAR HYPERTROPHY RSR PRIME

Electrocardiographic findings suggestive of an enlarged right ventricle. (NCI) An electrocardiographic finding in which there are two R waves, which are two deflections above the baseline resulting from a single ventricular depolarization. The first upward deflection in the complex is the R wave. The S is the first downward deflection. A second upward deflection is called the R-prime wave. An abnormal S wave that is part of the QRS complex in an electrocardiographic recording, which occurs due to a disturbance in the depolarization of the ventricular myocardium. (NCI) Electrocardiographic findings suggesting an infarction in the anatomic location of the cardiac septum. (NCI) A PR interval of less than 0.12 seconds. (NCI) A constellation of signs and symptoms which may include syncope, fatigue, dizziness, and alternating periods of bradycardia and atrial tachycardia, which is caused by sinoatrial node dysfunction. (NCI) A blockage of electrical conduction within the sinoatrial node resulting in the failure of impulse transmission from the sinoatrial node. (NCI) A failure of impulse formation in the sinus node. Sinus arrest is indistinguishable from third degree sinoatrial exit block on the standard ECG. (NCI) Irregularity of the heartbeat due to a variation in the sinus rhythm resulting in cyclic changes in the heart rate during breathing. This rhythm is most commonly seen with breathing due to fluctuations in parasympathetic vagal tone. During inspiration stretch receptors in the lungs stimulate the cardioinhibitory centers in the medulla via fibers in the vagus nerve. Irregularity of the heartbeat due to a variation in the sinus rhythm resulting in cyclic changes in the heart rate during breathing. This rhythm is most commonly seen with breathing due to fluctuations in parasympathetic vagal tone. During inspiration stretch receptors in the lungs stimulate the cardioinhibitory centers in the medulla via fibers in the vagus nerve. (NCI)

EKG Finding Right Ventricular Hypertrophy RSR'

C90451

S WAVE ABNORMALITY

S Wave Abnormality

S Wave Abnormality

C71082

SEPTAL MYOCARDIAL INFARCTION SHORT PR INTERVAL SICK SINUS SYNDROME

Septal myocardial infarction Short PR interval Sick sinus syndrome

Septal Myocardial Infarction

C62246 C62244

Short PR Interval Sick Sinus Syndrome

C50553

SINOATRIAL EXIT BLOCK

Sinoatrial exit block Sinus arrest/pause Sinus arrhythmia

Sinoatrial Node Exit Block

C62242

SINUS ARREST/PAUSE

Sinus Arrest

C62239

SINUS ARRHYTHMIA

Sinus Arrhythmia

C26923

SINUS BRADYCARDIA

Sinus bradycardia A heart rate of less than 60 beats per minute, with its origin in the sinus node. (NCI)

Sinus Bradycardia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 67 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Sinus node dysfunction (bradycardia)

NCI Code C62243

CDISC Submission Value SINUS NODE DYSFUNCTION (BRADYCARDIA)

CDISC Definition A derangement in the normal functioning of the sinoatrial node. Typically, SA node dysfunction is manifest as sinoatrial exit block or sinus arrest, but may present as an absolute or relative bradycardia in the presence of a stressor. It may be associated with bradycardia-tachycardia syndrome. (NCI) A heart rate of more than 100 beats per minute, with its origin in the sinus node. (NCI) An electrocardiographic finding of ST segment depression below the baseline, often described as up sloping, down sloping or horizontal. (NCI) An electrocardiographic finding of ST segment elevation above the baseline. (NCI) An electrocardiographic finding of ST changes consistent with pericarditis. (NCI) An electrocardiographic finding of the ST segment elevation or depression which is not indicative of ischemia or infarction. (NCI) A generic expression for any tachycardia that originates in the atria or the atrioventricular node. (NCI) An electrocardiographic finding of ventricular tachycardia greater than 30 seconds in duration. (NCI) An electrocardiographic finding of a T wave which appears peaked, inverted, flattened or biphasic. (NCI)

NCI Preferred Term Sinus Node Dysfunction

C26889 C71027

SINUS TACHYCARDIA ST DEPRESSION

Sinus tachycardia ST depression

Sinus Tachycardia ST Depression

C50540 C71029 C71026

ST ELEVATION ST ELEVATION PERICARDITIS ST SEGMENT ABNORMALITY SUPRAVENTRICULAR TACHYCARDIA

ST elevation ST elevation pericarditis ST segment abnormality Supraventricular tachycardia

ST Elevation ST Elevation Pericarditis ST Segment Abnormality

C35061

Supraventricular Tachycardia

C71052

SUSTAINED VENTRICULAR Sustained TACHYCARDIA ventricular tachycardia T WAVE ABNORMALITY T WAVE INVERSION T WAVE PEAKED T wave abnormality

Sustained Ventricular Tachycardia

C71083 C71085 C71086

T Wave Abnormality T Wave Inversion T Wave Peaked

T Wave Inversion An electrocardiographic finding of an inversion of the T wave from the expected axis. (NCI) T wave peaked An electrocardiographic finding in which the T wave appears increased in amplitude and cresting at a point. (NCI) An electrocardiographic finding in which the T wave is asymmetric. (NCI) An electrocardiographic finding in which the T wave appears decreased in amplitude. (NCI) An abnormally rapid heartbeat, usually applied to a heart rate above 100 per minute. An atypical rapid polymorphic ventricular tachycardia with a characteristic rotation of the QRS complex around the isoelectric baseline. In addition the QRS complex displays a periodic waxing and waning of amplitude on the electrogram. (NCI) An electrocardiographic finding of normal QRS followed by a premature ventricular contraction; a rhythmic pairing of normal and abnormal beats originating from the ventricles in a 1-2 ratio. (NCI)

C71087 C71088 C38029 C50779

T WAVES BIPHASIC T WAVES FLAT TACHYCARDIA TORSADES DE POINTES

T waves biphasic T waves flat Tachycardia Torsades de pointes

T Waves Biphasic T Waves Flat Tachycardia Torsades De Pointes

C71055

TRIGEMINY

Trigeminy

Trigeminy

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 68 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym U waves

NCI Code C71089

CDISC Submission Value U WAVES

CDISC Definition An electrocardiographic finding of a small hump following the T wave occurring during the final phase of Purkinje repolarization. (NCI) Polymorphic ventricular tachycardia in the absence of structural heart disease, associated with a baseline ECG pattern during sinus rhythm showing right bundle branch block with ST segment elevation in leads V1 through V3. It can also be characterized by documentation of ECG patterns associated with Brugada Syndrome, some of which may be unmasked when provoked with drugs. The most common genetic mutations identified for Brugada syndrome are in the sodium channel gene SCN5A. Long QT Syndrome includes prolongation of the corrected QT interval beyond 440 ms for adult males, 460 ms for adult females and 50 ms in the presence of ventricular depolarization abnormalities (i.e., bundle branch blocks or IVCB more than 120 ms. A normal QT interval in a resting ECG with a failure to shorten with an increase in heart rate qualifies as Long QT Syndrome. Short QT Syndrome is characterized by a QT interval of less than or equal to 300 ms.

NCI Preferred Term U Waves

C71059

VENTRICULAR ARRHYTHMIA ASSOCIATED WITH BRUGADA SYNDROME

Ventricular arrhythmia associated with Brugada syndrome

Brugada Syndrome

C34786

VENTRICULAR ARRHYTHMIA ASSOCIATED WITH LONG QT SYNDROME

Ventricular arrhythmia associated with long QT syndrome

Long QT Syndrome

C71060

VENTRICULAR ARRHYTHMIA ASSOCIATED WITH SHORT QT SYNDROME VENTRICULAR COUPLET

Ventricular arrhythmia associated with short QT syndrome Ventricular couplet

Short QT Syndrome

C62259

Two sequential ventricular premature complexes. An otherwise normal finding, but possibly indicative of electrical heart disease particularly in comparison with a single ventricular premature complexes. (NCI) A compensatory ectopic beat that occurs in the ventricle after a pause in the ventricular rhythm, which is due to an absence in electrical activity to the ventricles. (NCI) Ventricular Fibrillation is characterized by rapid, usually more than 300 bpm (cycle length: 180 ms or less), grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. A ventricular tachyarrhythmia characterized by a high ventricular rate (180 and 250 beats per minute) with a regular rhythm. The electrocardiogram shows large oscillating sine wave-like complexes occurring as a result of QRS complexes and T waves being merged. The P wave is not visible. (NCI) Electrocardiographic findings suggestive of enlarged cardiac ventricles. (NCI) A tachycardia arising distal to bundle of His, with a rate greater than 100 beats per minute. (NCI) Multiple, temporally related, episodes of ventricular tachycardia or fibrillation, occurring three or more times in a 24 hour period. (NCI)

Ventricular Couplet

C90483

VENTRICULAR ESCAPE BEAT

Ventricular Escape Beat

Ventricular Escape Beat

C50799

VENTRICULAR FIBRILLATION

Ventricular fibrillation

Ventricular Fibrillation

C50800

VENTRICULAR FLUTTER

Ventricular flutter

Ventricular Flutter

C71084 C50802 C71056

VENTRICULAR HYPERTROPHY VENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA STORM

Ventricular Hypertrophy Ventricular tachycardia Ventricular tachycardia storm

Ventricular Hypertrophy Ventricular Tachycardia Ventricular Tachycardia Storm

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 69 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71150 - EGSTRESC - ECG Result Codelist extensible: Yes
CDISC Synonym Ventricular tachycardia, monomorphic Ventricular tachycardia, polymorphic Verapamil-sensit ive ventricular tachycardia

NCI Code C62234

CDISC Submission Value VENTRICULAR TACHYCARDIA, MONOMORPHIC VENTRICULAR TACHYCARDIA, POLYMORPHIC VERAPAMIL-SENSITIVE VENTRICULAR TACHYCARDIA

CDISC Definition A ventricular tachycardia in which the ventricular activation sequence is constant. The morphology of the electrocardiographic waveform is unchanging and is referred to as monomorphic. (NCI) A ventricular tachycardia in which the ventricular activation sequence is variable. The morphology of the electrocardiographic waveform is variable and is referred to as polymorphic. (NCI) A well-recognized condition that is believed to result from triggered activity. Despite its uniform response to verapamil, however, this uncommon form of ventricular tachycardia may not be as homogeneous a condition as first believed. (NCI) A condition characterized by the site of origin of impulses, controlling the heart rate, changing within the atria, including the sinus node. Variations within P waves and PR intervals occur and an irregular rate of impulse formation is observed. (NCI) An electrocardiographic finding of a QRS complex. (NCI) A type of ventricular pre-excitation resulting from the activation of an accessory pathway known as the Bundle of Kent. This pathway presents an abnormal electrical communication from the atria to the ventricles. Wolff-Parkinson-White syndrome is characterized by a short PR interval and a long QRS interval with a delta wave. (NCI)

NCI Preferred Term Monomorphic Ventricular Tachycardia

C62236

Polymorphic Ventricular Tachycardia

C71058

Verapamil-Sensitive Ventricular Tachycardia

C62240

WANDERING ATRIAL PACEMAKER

Wandering atrial pacemaker

Wandering Atrial Pacemaker

C71090 C35132

WIDE QRS TACHYCARDIA WOLFF-PARKINSON-WHIT E SYNDROME

Wide QRS tachycardia Wolff-Parkinson -White syndrome

Wide QRS Tachycardia Wolff-Parkinson-White Syndrome

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 70 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym Interpretation

NCI Code C41255

CDISC Submission Value Interpretation

CDISC Definition An act or process of elucidation; explication, or explanation of the meaning of the event or thing via the assignment of objects from the domain to the constants of a formal language, truth-values to the proposition symbols, truth-functions to the connectives, other functions to the function symbols, and extensions to the predicates, if any. The assignments are result of human logic application and are not native to the symbols of the formal language. A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcB = JT/SqRootRR(seconds) and theoretically corrects the JT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcF = JT/CubeRootRR(seconds) and theoretically corrects the JT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. The linear correction formula uses population-based data obtained and validated using a large cohort of subjects. Using this method, the corrected JT interval is independent of the ventricular rate. (NCI) The average (mean) duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval while the ventricle rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize. The time interval between the start of the Q wave and the end of the T wave in the cardiac cycle as corrected with a non-specified correction formula. A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcB = QT/SqRootRR(seconds) and theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI)

NCI Preferred Term Interpretation

C62118

JTcB - Bazett's Correction Formula

JTcB - Bazett's Correction Formula

JTcB-Bazett's Correction Formula

C62119

JTcF - Fridericia's Correction Formula

JTcF Fridericia's Correction Formula

JTcF-Fridericia's Correction Formula

C62120

JTcLC - Linear Correction Formula

JTcLC - Linear Correction Formula

JTcLC-Linear Correction Formula

C100390

QRS Duration Ventricular Paced

QRS Duration Ventricular Paced

EKG Mean QRS Duration Ventricular Paced

C100391

QT Interval, Corrected

QT Interval, Corrected QTcB - Bazett's Correction Formula

Corrected QT Interval

C62112

QTcB - Bazett's Correction Formula

QTcB-Bazett's Correction Formula

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 71 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym QTcF Fridericia's Correction Formula

NCI Code C62113

CDISC Submission Value QTcF - Fridericia's Correction Formula

CDISC Definition A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcF = QT/CubeRootRR(seconds) and theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. The linear correction formula uses population-based data obtained and validated using a large cohort of subjects. This method theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A mathematic formula defined as: QTcV = QT-0.087[(60/Heart Rate)-1](seconds). It permits comparison of the QT interval across a range of rates, while accounting for the progressive shortening of the QT interval which occurs as the heart rate increases. (NCI) The minimum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) The maximum duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The maximum duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The maximum duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI)

NCI Preferred Term QTcF-Fridericia's Correction Formula

C62114

QTcLC - Linear Correction Formula

QTcLC - Linear Correction Formula

QTcLC-Linear Correction Formula

C90442

QTcV - Van de Water's Correction Formula

QTcV - Van de Water's Correction Formula

QTcV Van de Water's Correction Formula

C39779

Summary (Max) Heart Rate

Summary (Max) Heart Rate

Maximum Heart Rate

C62117

Summary (Max) JT Interval

Summary (Max) JT Interval

EKG Maximum JT Duration

C62131

Summary (Max) PR Duration

Summary (Max) PR Duration

EKG Maximum PR Duration

C62135

Summary (Max) QT Duration

Summary (Max) QT Duration

EKG Maximum QT Duration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 72 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym Summary (Max) RR Duration Summary (Max) ST Depression

NCI Code C62094

CDISC Submission Value Summary (Max) RR Duration

CDISC Definition The maximum duration (time) between successive peaks of R waves in a particular set of RR intervals. (NCI) The maximum depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI) The maximum deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) The maximum elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The maximum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) The average (mean) number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) The average (mean) duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The mean (average) direction (range -180 degrees to 180 degrees) of the electrical potential generated by atrial depolarization in a particular plane (usually the frontal plane). (NCI) The average (mean) duration (time) from the onset of atrial depolarization to the completion of atrial depolarization (length of the P wave), obtained from a set of measurements of the time from beginning to end of atrial depolarization. (NCI) The average (mean) height (usually measured in mm) of the maximum deflection from baseline of the P wave (representing atrial depolarization), obtained from a set of measurements of the P wave, from a single lead or set of leads. Typically this measurement is obtained by analysis of Lead II. (NCI)

NCI Preferred Term EKG Maximum RR Duration

C62163

Summary (Max) ST Depression

EKG Maximum ST Segment Depression

C62157

Summary (Max) ST Deviation

Summary (Max) ST Deviation

EKG Maximum ST Deviation

C62160

Summary (Max) ST Elevation

Summary (Max) ST Elevation

EKG Maximum ST Segment Elevation

C62154

Summary (Max) Ventricular Rate

Summary (Max) Ventricular Rate

Maximum Ventricular Heart Rate

C62095

Summary (Mean) Heart Rate

Summary (Mean) Heart Rate

Mean Heart Rate

C62115

Summary (Mean) JT Interval

Summary (Mean) JT Interval

EKG Mean JT Duration

C62121

Summary (Mean) P Axis

Summary (Mean) P Axis

EKG Mean P Axis

C62123

Summary (Mean) P Wave Duration

Summary (Mean) P Wave Duration

EKG Mean P Wave Duration

C62124

Summary (Mean) P Wave Height

Summary (Mean) P Wave Height

EKG Mean P Wave Height

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 73 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym Summary (Mean) PR Duration

NCI Code C62086

CDISC Submission Value Summary (Mean) PR Duration

CDISC Definition The average (mean) duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The mean (average) direction of the electrical potential generated by ventricular depolarization. (NCI) The average (mean) duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize. (NCI) The average (mean) duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI) The average (mean) amplitude (usually in mm) of the R wave, obtained from a set of measurements of the R wave, in a particular lead or set of leads. (NCI) The average (mean) amplitude (usually in mm) of the summation of the R and S waves, obtained from a set of measurements of the R and S waves, in a particular lead or set of leads. (NCI) The average (mean) duration (time) of the RR interval, obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. (NCI) The average (mean) amplitude (usually in mm) of the S wave, obtained from a set of measurements of the S wave, in a particular lead or set of leads. (NCI) The average (mean) depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI) The average (mean) deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI)

NCI Preferred Term EKG Mean PR Duration

C62132

Summary (Mean) QRS Axis

Summary (Mean) QRS Axis Summary (Mean) QRS Duration

Mean QRS Axis

C62087

Summary (Mean) QRS Duration

EKG Mean QRS Duration

C62089

Summary (Mean) QT Duration

Summary (Mean) QT Duration

EKG Mean QT Duration

C62136

Summary (Mean) R Wave Amplitude Summary (Mean) R+S Amplitude

Summary (Mean) R Wave Amplitude Summary (Mean) R+S Amplitude

EKG Mean R Wave Amplitude

C62144

EKG Mean R+S Amplitude

C62090

Summary (Mean) RR Duration

Summary (Mean) RR Duration

EKG Mean RR Duration

C62137

Summary (Mean) S Wave Amplitude Summary (Mean) ST Depression

Summary (Mean) S Wave Amplitude Summary (Mean) ST Depression

EKG Mean S Wave Amplitude

C62161

EKG Mean ST Segment Depression

C62155

Summary (Mean) ST Deviation

Summary (Mean) ST Deviation

EKG Mean ST Deviation

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 74 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym

NCI Code C62158

CDISC Submission Value

CDISC Definition The average (mean) elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The average (mean) duration (time) from the end of ventricular depolarization (end of QRS complex) to the end of ventricular repolarization (end of the T wave). (NCI) The average (mean) area under the curve of the deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) The mean (average) direction of the electrical potential generated by ventricular repolarization. (NCI) The average (mean) duration (time) from the onset of ventricular repolarization to the completion of ventricular repolarization (length of the T wave), obtained from a set of measurements of the time from beginning to end of ventricular repolarization. (NCI) The average (mean) height (usually measured in mm) of the maximum deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) The average (mean) number of cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) The median number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. The median duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. The median duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize.

NCI Preferred Term EKG Mean ST Segment Elevation

Summary (Mean) ST Elevation Summary (Mean) ST Elevation

C62145

Summary (Mean) ST Segment Duration

Summary (Mean) ST Segment Duration

EKG Mean ST Segment Duration

C62148

Summary (Mean) T Wave Area Summary (Mean) T Wave Area

EKG Mean T Wave Area

C62146 C62147

Summary (Mean) T Wave Axis Summary (Mean) T Wave Axis Summary (Mean) T Wave Duration Summary (Mean) T Wave Duration

EKG Mean T Wave Axis EKG Mean T Wave Duration

C62149

Summary (Mean) T Wave Height

Summary (Mean) T Wave Height

EKG Mean T Wave Height

C62152

Summary (Mean) Ventricular Rate

Summary (Mean) Ventricular Rate

Mean Ventricular Heart Rate

C102249

Summary (Median) Heart Rate

Summary (Median) Heart Rate Summary (Median) PR Duration

Median Heart Rate

C102250

Summary (Median) PR Duration

Median PR Duration

C102251

Summary (Median) QRS Duration

Summary (Median) QRS Duration

Median QRS Duration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 75 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym Summary (Median) QT Duration

NCI Code C102252

CDISC Submission Value Summary (Median) QT Duration

CDISC Definition The median duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. The median duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Fridericia's correction Formula. The median duration (time) of the RR interval, obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. The maximum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) The minimum duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The minimum duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The minimum duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI) The minimum duration (time) between successive peaks of R waves in a particular set of RR intervals. (NCI)

NCI Preferred Term Median QT Duration

C102253

Summary (Median) QTcF

Summary (Median) QTcF

Median QTcF

C102254

Summary (Median) RR Duration

Summary (Median) RR Duration

Median RR Duration

C62096

Summary (Min) Heart Rate

Summary (Min) Heart Rate

Minimum Heart Rate

C62116

Summary (Min) JT Interval

Summary (Min) JT Interval

EKG Minimum JT Duration

C62125

Summary (Min) PR Duration

Summary (Min) PR Duration

EKG Minimum PR Duration

C62133

Summary (Min) QT Duration

Summary (Min) QT Duration

Minimum QT Duration

C62093

Summary (Min) RR Duration

Summary (Min) RR Duration

EKG Minimum RR Duration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 76 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71152 - EGTEST - ECG Test Name Codelist extensible: Yes
CDISC Synonym Summary (Min) ST Depression

NCI Code C62162

CDISC Submission Value Summary (Min) ST Depression

CDISC Definition The minimum depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI) The minimum deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) The minimum elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The minimum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI)

NCI Preferred Term EKG Minimum ST Segment Depression

C62156

Summary (Min) ST Deviation

Summary (Min) ST Deviation

EKG Minimum ST Deviation

C62159

Summary (Min) ST Elevation

Summary (Min) ST Elevation

EKG Minimum ST Segment Elevation

C62153

Summary (Min) Ventricular Rate

Summary (Min) Ventricular Rate

Minimum Ventricular Heart Rate

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 77 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Max) Heart Rate

NCI Code C39779

CDISC Submission Value HRMAX

CDISC Definition The minimum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) The average (mean) number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) The median number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. The maximum time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI) An act or process of elucidation; explication, or explanation of the meaning of the event or thing via the assignment of objects from the domain to the constants of a formal language, truth-values to the proposition symbols, truth-functions to the connectives, other functions to the function symbols, and extensions to the predicates, if any. The assignments are result of human logic application and are not native to the symbols of the formal language. A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcB = JT/SqRootRR(seconds) and theoretically corrects the JT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. It is mathematically defined as: JTcF = JT/CubeRootRR(seconds) and theoretically corrects the JT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the JT interval which occurs as the heart rate increases, permitting comparison of the JT interval across a range of rates. The linear correction formula uses population-based data obtained and validated using a large cohort of subjects. Using this method, the corrected JT interval is independent of the ventricular rate. (NCI)

NCI Preferred Term Maximum Heart Rate

C62095

HRMEAN

Summary (Mean) Heart Rate

Mean Heart Rate

C102249

HRMED

Summary (Median) Heart Rate Summary (Min) Heart Rate

Median Heart Rate

C62096

HRMIN

Minimum Heart Rate

C41255

INTP

Interpretation

Interpretation

C62118

JTCB

JTcB - Bazett's Correction Formula

JTcB-Bazett's Correction Formula

C62119

JTCF

JTcF Fridericia's Correction Formula

JTcF-Fridericia's Correction Formula

C62120

JTCLC

JTcLC - Linear Correction Formula

JTcLC-Linear Correction Formula

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 78 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Max) JT Interval

NCI Code C62117

CDISC Submission Value JTMAX

CDISC Definition The maximum duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The average (mean) duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The minimum duration (time) of the JT interval, obtained from a set of measurements of the JT interval. The JT interval is defined as the time from the J point (end of ventricular depolarization, the point at which the QRS meets the ST segment) to the end of the T wave (representing the end of ventricular repolarization). (NCI) The mean (average) direction (range -180 degrees to 180 degrees) of the electrical potential generated by atrial depolarization in a particular plane (usually the frontal plane). (NCI) The maximum duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The average (mean) duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The median duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave.

NCI Preferred Term EKG Maximum JT Duration

C62115

JTMEAN

Summary (Mean) JT Interval

EKG Mean JT Duration

C62116

JTMIN

Summary (Min) JT Interval

EKG Minimum JT Duration

C62121

PAXIS

Summary (Mean) P Axis

EKG Mean P Axis

C62131

PRMAX

Summary (Max) PR Duration

EKG Maximum PR Duration

C62086

PRMEAN

Summary (Mean) PR Duration

EKG Mean PR Duration

C102250

PRMED

Summary (Median) PR Duration

Median PR Duration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 79 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Min) PR Duration

NCI Code C62125

CDISC Submission Value PRMIN

CDISC Definition The minimum duration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave. (NCI) The average (mean) duration (time) from the onset of atrial depolarization to the completion of atrial depolarization (length of the P wave), obtained from a set of measurements of the time from beginning to end of atrial depolarization. (NCI) The average (mean) height (usually measured in mm) of the maximum deflection from baseline of the P wave (representing atrial depolarization), obtained from a set of measurements of the P wave, from a single lead or set of leads. Typically this measurement is obtained by analysis of Lead II. (NCI) The mean (average) direction of the electrical potential generated by ventricular depolarization. (NCI) The average (mean) duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize. (NCI) The average (mean) duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval while the ventricle rhythm is controlled by an electrical impulse from a mechanical cardiac pacemaker. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize. The median duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize. The time interval between the start of the Q wave and the end of the T wave in the cardiac cycle as corrected with a non-specified correction formula.

NCI Preferred Term EKG Minimum PR Duration

C62123

PWAVEDUR

Summary (Mean) P Wave Duration

EKG Mean P Wave Duration

C62124

PWAVEHT

Summary (Mean) P Wave Height

EKG Mean P Wave Height

C62132

QRSAXIS

Summary (Mean) QRS Axis Summary (Mean) QRS Duration

Mean QRS Axis

C62087

QRSDUR

EKG Mean QRS Duration

C100390

QRSDURVP

QRS Duration Ventricular Paced

EKG Mean QRS Duration Ventricular Paced

C102251

QRSMED

Summary (Median) QRS Duration

Median QRS Duration

C100391

QTC

QT Interval, Corrected

Corrected QT Interval

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 80 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym QTcB - Bazett's Correction Formula

NCI Code C62112

CDISC Submission Value QTCB

CDISC Definition A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcB = QT/SqRootRR(seconds) and theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. It is mathematically defined as: QTcF = QT/CubeRootRR(seconds) and theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) The median duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Fridericia's correction Formula. A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates. The linear correction formula uses population-based data obtained and validated using a large cohort of subjects. This method theoretically corrects the QT interval to that which would be observed at a heart rate of 1 cycle per second. (NCI) A mathematic formula defined as: QTcV = QT-0.087[(60/Heart Rate)-1](seconds). It permits comparison of the QT interval across a range of rates, while accounting for the progressive shortening of the QT interval which occurs as the heart rate increases. (NCI) The maximum duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI) The average (mean) duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI)

NCI Preferred Term QTcB-Bazett's Correction Formula

C62113

QTCF

QTcF Fridericia's Correction Formula

QTcF-Fridericia's Correction Formula

C102253

QTCFMED

Summary (Median) QTcF

Median QTcF

C62114

QTCLC

QTcLC - Linear Correction Formula

QTcLC-Linear Correction Formula

C90442

QTCV

QTcV - Van de Water's Correction Formula

QTcV Van de Water's Correction Formula

C62135

QTMAX

Summary (Max) QT Duration

EKG Maximum QT Duration

C62089

QTMEAN

Summary (Mean) QT Duration

EKG Mean QT Duration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 81 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Median) QT Duration

NCI Code C102252

CDISC Submission Value QTMED

CDISC Definition The median duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. The minimum duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave. (NCI) The maximum duration (time) between successive peaks of R waves in a particular set of RR intervals. (NCI) The average (mean) duration (time) of the RR interval, obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. (NCI) The median duration (time) of the RR interval, obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate. The minimum duration (time) between successive peaks of R waves in a particular set of RR intervals. (NCI) The average (mean) amplitude (usually in mm) of the summation of the R and S waves, obtained from a set of measurements of the R and S waves, in a particular lead or set of leads. (NCI) The average (mean) amplitude (usually in mm) of the R wave, obtained from a set of measurements of the R wave, in a particular lead or set of leads. (NCI) The maximum depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI) The average (mean) depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI) The minimum depression (negative deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the depression of the ST segment. (NCI)

NCI Preferred Term Median QT Duration

C62133

QTMIN

Summary (Min) QT Duration

Minimum QT Duration

C62094

RRMAX

Summary (Max) RR Duration Summary (Mean) RR Duration

EKG Maximum RR Duration

C62090

RRMEAN

EKG Mean RR Duration

C102254

RRMED

Summary (Median) RR Duration

Median RR Duration

C62093

RRMIN

Summary (Min) RR Duration Summary (Mean) R+S Amplitude

EKG Minimum RR Duration

C62144

RSAMP

EKG Mean R+S Amplitude

C62136

RWAVEAMP

Summary (Mean) R Wave Amplitude Summary (Max) ST Depression

EKG Mean R Wave Amplitude

C62163

STDPMAX

EKG Maximum ST Segment Depression

C62161

STDPMEAN

Summary (Mean) ST Depression

EKG Mean ST Segment Depression

C62162

STDPMIN

Summary (Min) ST Depression

EKG Minimum ST Segment Depression

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 82 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Max) ST Deviation

NCI Code C62157

CDISC Submission Value STDVMAX

CDISC Definition The maximum deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) The average (mean) deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) The minimum deviation (distance from baseline, positive or negative, usually measured in mm) of the ST segment, obtained from a set of measurements of the deviation of the ST segment. (NCI) The maximum elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The average (mean) elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The minimum elevation (positive deflection from baseline, usually measured in mm) of the ST segment, obtained from a set of measurements of the elevation of the ST segment. (NCI) The duration (time) of the ST segment, measured from the J point at the end of the QRS complex to the beginning of the T wave. (NCI) The average (mean) amplitude (usually in mm) of the S wave, obtained from a set of measurements of the S wave, in a particular lead or set of leads. (NCI) The mean (average) direction of the electrical potential generated by ventricular repolarization. (NCI) The average (mean) area under the curve of the deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI) The average (mean) duration (time) from the onset of ventricular repolarization to the completion of ventricular repolarization (length of the T wave), obtained from a set of measurements of the time from beginning to end of ventricular repolarization. (NCI) The average (mean) height (usually measured in mm) of the maximum deflection from baseline of the T wave (representing ventricular repolarization), obtained from a set of measurements of the T wave, from a single lead or set of leads. (NCI)

NCI Preferred Term EKG Maximum ST Deviation

C62155

STDVMEAN

Summary (Mean) ST Deviation

EKG Mean ST Deviation

C62156

STDVMIN

Summary (Min) ST Deviation

EKG Minimum ST Deviation

C62160

STELMAX

Summary (Max) ST Elevation

EKG Maximum ST Segment Elevation

C62158

STELMEAN

Summary (Mean) ST Elevation

EKG Mean ST Segment Elevation

C62159

STELMIN

Summary (Min) ST Elevation

EKG Minimum ST Segment Elevation

C62145

STSEGDUR

Summary (Mean) ST Segment Duration Summary (Mean) S Wave Amplitude Summary (Mean) T Wave Axis Summary (Mean) T Wave Area

EKG Mean ST Segment Duration

C62137

SWAVEAMP

EKG Mean S Wave Amplitude

C62146 C62148

TAXIS TWAVAREA

EKG Mean T Wave Axis EKG Mean T Wave Area

C62147

TWAVEDUR

Summary (Mean) T Wave Duration

EKG Mean T Wave Duration

C62149

TWAVEHT

Summary (Mean) T Wave Height

EKG Mean T Wave Height

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 83 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71153 - EGTESTCD - ECG Test Code Codelist extensible: Yes
CDISC Synonym Summary (Max) Ventricular Rate

NCI Code C62154

CDISC Submission Value VRMAX

CDISC Definition The maximum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) The average (mean) number of cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI) The minimum time between successive cycles of contraction and subsequent relaxation of the ventricles, usually expressed as beats per minute, obtained from a set of measurements of the ventricular rate. (NCI)

NCI Preferred Term Maximum Ventricular Heart Rate

C62152

VRMEAN

Summary (Mean) Ventricular Rate

Mean Ventricular Heart Rate

C62153

VRMIN

Summary (Min) Ventricular Rate

Minimum Ventricular Heart Rate

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 84 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99079 - EPOCH - Epoch Codelist extensible: Yes
CDISC Synonym

NCI Code C102255 C99158

CDISC Submission Value BLINDED TREATMENT FOLLOW-UP

CDISC Definition A period in a clinical study during which subjects receive blinded therapeutic treatment. A period in a clinical study during which information about the health status of an individual is obtained after study procedures and treatments have concluded. A period in a clinical study during which subjects receive open label therapeutic treatment. A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason. A period in a clinical study during which subjects are evaluated for participation in the study. A period in a clinical study during which subjects receive therapeutic treatment. A period of time during a clinical study when a participant is taken off of a study drug or other medication in order to eliminate the effects of the treatment.

NCI Preferred Term Blinded Treatment Epoch Clinical Study Follow-up

C102256 C98779

OPEN LABEL TREATMENT RUN-IN

Open Label Treatment Epoch Run-in Period

C48262 C49236 C42872

SCREENING TREATMENT WASHOUT

Trial Screening Therapeutic Procedure Washout Period

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 85 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66790 - ETHNIC - Ethnic Group Codelist extensible: Yes
CDISC Synonym

NCI Code C17459

CDISC Submission Value HISPANIC OR LATINO

CDISC Definition A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. An arbitrary ethnic classification. (NCI)

NCI Preferred Term Hispanic or Latino

C41222

NOT HISPANIC OR LATINO

Not Hispanic or Latino

C43234 C17998

NOT REPORTED UNKNOWN

Not reported U; Unknown

Not provided or available. Not known, not observed, not recorded, or refused. (NCI)

Not Stated Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 86 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78735 - EVAL - Evaluator Codelist extensible: Yes
CDISC Synonym

NCI Code C78726

CDISC Submission Value ADJUDICATION COMMITTEE CAREGIVER

CDISC Definition An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met. (NCI)

NCI Preferred Term Adjudication Committee

C17445

Caregiver

The primary person in charge of the care of a patient, usually a family member or a designated health care professional. (NCI) A son or a daughter.

Caregiver

C42708 C25465

CHILD CLINICAL RESEARCH ASSOCIATE Research Associate

Child Clinical Research Associate

A person who is employed by a study sponsor or by a contract research organization (CRO), operates independently from the clinical study site and functions as a monitor, and/or auditor, and/or a project director within a particular trial or institution. (NCI) A person to whom a clinical investigator delegates routine administrative requirements of a protocol. The duties and responsibilities of a clinical research coordinator may vary across different infrastructures. Generally, the coordinator manages the subject's clinical trial participation and provides a vital linkage between the subject, the investigator, and the sponsor. (NCI)

C51811

CLINICAL RESEARCH COORDINATOR

Clinical Coordinator

C70793

CLINICAL STUDY SPONSOR

Clinical Study Sponsor; Study Sponsor, Sponsor Domestic Partner

An entity that is responsible for the initiation, management, and/or financing of a clinical study.

Clinical Study Sponsor

C53262

DOMESTIC PARTNER

A person who is a member of an unmarried couple, including same sex couples living together in longstanding relationships, that are registered or unregistered. (NCI) A person whom an individual knows, likes, and trusts. (NCI) An individual who is authorized under applicable State or local law to consent on behalf of a child or incapable person to general medical care including participation in clinical research. (NCI) A person qualified to be engaged in activity directed at preservation of mental and physical health by diseases prevention and treatment as a source of livelihood. (NCI) An individual qualified to perform an evaluation who is masked from a subject's data in order to minimize bias or maximize consistency and quality. (NCI) A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principle investigator. A mother or a father.

Domestic Partnership

C72884 C51828

FRIEND GUARDIAN

Friend Guardian

C53287

HEALTH CARE PROFESSIONAL

Health Care Professional

C78720

INDEPENDENT ASSESSOR

Independent Rater

C25936

INVESTIGATOR

Investigator

C42709

PARENT

Parent

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 87 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78735 - EVAL - Evaluator Codelist extensible: Yes
CDISC Synonym Spouse

NCI Code C62649 C41189

CDISC Submission Value SPOUSE STUDY SUBJECT

CDISC Definition A person's partner in marriage. (NCI) An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. Spouse

NCI Preferred Term

Study Subject

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 88 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71113 - FREQ - Frequency Codelist extensible: Yes
CDISC Synonym One Time Per Week 2 Times Per Year 3 Times Per Month 3 Times Per Year 4 Times Per Month 4 Times Per Year 5 Times Daily 5 Times Per Month 5 Times Per Week 5 Times Per Year 6 Times Daily 6 Times Per Month 6 Times Per Week 6 Times Per Year 7 Times Per Week Ad Libitum BD; Twice per day Twice per month Twice per week Continuous

NCI Code C64526 C98861 C98859 C98860 C98852 C98853 C98849 C98850 C85552 C98851 C98855 C98856 C98857 C98858 C98854 C64636 C64496 C71129 C64497 C53279

CDISC Submission Value 1 TIME PER WEEK 2 TIMES PER YEAR 3 TIMES PER MONTH 3 TIMES PER YEAR 4 TIMES PER MONTH 4 TIMES PER YEAR 5 TIMES PER DAY 5 TIMES PER MONTH 5 TIMES PER WEEK 5 TIMES PER YEAR 6 TIMES PER DAY 6 TIMES PER MONTH 6 TIMES PER WEEK 6 TIMES PER YEAR 7 TIMES PER WEEK AD LIBITUM BID BIM BIS CONTINUOUS

CDISC Definition One time per week. (NCI) Two times per year. (NCI) Three times per month. (NCI) Three times per year. (NCI) Four times per month. (NCI) Four times per year. (NCI) Five times per day. (NCI) Five times per month. (NCI) Five times per week. (NCI) Five times per year. (NCI) Six times per day. (NCI) Six times per month. (NCI) Six times per week. (NCI) Six times per year. (NCI) Seven times per week. (NCI) As much as desired. Two times per day, at unspecified times. (NCI) Twice per month. (NCI) Two times per week. (NCI) Remain in force or carry on without letup; keep or maintain in unaltered condition; exist in time or space without stop or interruption. (NCI) Periodically stopping and starting. (NCI) Not occurring regularly or at short intervals. A one time intervention. (NCI) Different than the one(s) previously specified or mentioned. (NCI) A frequency rate of occurrences of something within a period of time equal to three hundred sixty-five days. As needed. (NCI) Every ten hours. (NCI)

NCI Preferred Term Once Weekly Two Times Yearly Three Times Monthly Three Times Yearly Four Times Monthly Four Times Yearly Five Times Daily Five Times Monthly Five Times Weekly Five Times Yearly Six Times Daily Six Times Monthly Six Times Weekly Six Times Yearly Seven Times Weekly As Much as Desired Twice Daily Twice Per Month Twice Weekly Continue

C71325 C64954 C64576 C17649 C74924 C64499 C64500

INTERMITTENT OCCASIONAL ONCE OTHER PA PRN Q10H

Intermittent Occasional Once Other Per Annum; Per Year; Every Year As needed Every 10 hours

Intermittent Infrequent Once Other Per Year As Necessary Every Ten Hours

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 89 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71113 - FREQ - Frequency Codelist extensible: Yes
CDISC Synonym Every 11 hours Every 12 hours Every 13 hours Every 14 hours Every 15 hours Every 16 hours Every 17 hours Every 18 hours Every 19 hours Every 20 hours Every 21 hours Every 22 hours Every 23 hours Every 24 hours Every 2 hours Every two months Every 2 weeks Every 3 days Every 3 hours Every 3 months Every 3 weeks Every 4 days Every 4 hours Every 4 months Every 4 weeks Every 5 days Every 5 hours Every 6 hours Every 6 Weeks Every 7 hours Every 8 hours Every 9 hours Daily Every hour

NCI Code C64501 C64502 C64503 C64504 C64505 C64506 C64507 C64508 C64509 C64511 C64512 C64513 C64514 C64515 C64516 C64536 C71127 C64533 C64517 C64537 C64535 C64534 C64518 C64538 C64529 C71124 C64519 C64520 C89788 C64521 C64523 C64524 C25473 C64510

CDISC Submission Value Q11H Q12H Q13H Q14H Q15H Q16H Q17H Q18H Q19H Q20H Q21H Q22H Q23H Q24H Q2H Q2M Q2S Q3D Q3H Q3M Q3S Q4D Q4H Q4M Q4S Q5D Q5H Q6H Q6S Q7H Q8H Q9H QD QH

CDISC Definition Every eleven hours. (NCI) Every twelve hours. (NCI) Every thirteen hours. (NCI) Every fourteen hours. (NCI) Every fifteen hours. (NCI) Every sixteen hours. (NCI) Every seventeen hours. (NCI) Every eighteen hours. (NCI) Every nineteen hours. (NCI) Every twenty hours. (NCI) Every twenty-one hours. (NCI) Every twenty-two hours. (NCI) Every twenty-three hours. (NCI) Every twenty-four hours. (NCI) Every two hours. (NCI) Every two months. (NCI) Every two weeks. (NCI) Every three days. (NCI) Every three hours. (NCI) Every three months. (NCI) Every three weeks. (NCI) Every four days. (NCI) Every four hours. (NCI) Every four months. (NCI) Every four weeks. (NCI) Every five days. (NCI) Every five hours. (NCI) Every six hours. (NCI) Every six weeks. (NCI) Every seven hours. (NCI) Every eight hours. (NCI) Every nine hours. (NCI) Occurring or done each day. Every hour. (NCI)

NCI Preferred Term Every Eleven Hours Every Twelve Hours Every Thirteen Hours Every Fourteen Hours Every Fifteen Hours Every Sixteen Hours Every Seventeen Hours Every Eighteen Hours Every Nineteen Hours Every Twenty Hours Every Twenty-One Hours Every Twenty-Two Hours Every Twenty-Three Hours Every Twenty-Four Hours Every Two Hours Every Two Months Every Two Weeks Every Three Days Every Three Hours Every Three Months Every Three Weeks Every Four Days Every Four Hours Every Four Months Every Four Weeks Every Five Days Every Five Hours Every Six Hours Every Six Weeks Every Seven Hours Every Eight Hours Every Nine Hours Daily Every Hour

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 90 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71113 - FREQ - Frequency Codelist extensible: Yes
CDISC Synonym 4 times per day 4 times per week Every Month; Per Month Every other day Every week; Per Week 3 times per day Three times a week U; Unknown

NCI Code C64530 C64531 C64498 C64525 C67069 C64527 C64528 C17998

CDISC Submission Value QID QIS QM QOD QS TID TIS UNKNOWN

CDISC Definition Four times per day. (NCI) Four times per week. (NCI) Every month. (NCI) Every other day. (NCI) Every week. (NCI) Three times per day. (NCI) Three times per week. (NCI) Not known, not observed, not recorded, or refused. (NCI)

NCI Preferred Term Four Times Daily Four Times Weekly Monthly Every Other Day Weekly Three Times Daily Three Times Weekly Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 91 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym aer

NCI Code C42887

CDISC Submission Value AEROSOL

CDISC Definition A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (FDA) A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. (FDA) A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation. (NCI) A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. (NCI) An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents. (NCI) A solid dosage form usually in the form of a rectangle that is meant to be chewed. (NCI) A solid dosage form in the shape of a small ball. (NCI) A small sterile solid mass consisting of a highly purified drug intended for implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. (NCI) Solid dosage form, usually in the shape of a square or rectangle. (NCI) A solid dosage form in which a tablet has been compacted into capsule shape.

NCI Preferred Term Aerosol Dosage Form

C42888

AEROSOL, FOAM

Aerosol Foam Dosage Form

C42960

AEROSOL, METERED

Metered Aerosol Dosage Form

C42971

AEROSOL, POWDER

Powder Aerosol Dosage Form

C42889

AEROSOL, SPRAY

Aerosol Spray Dosage Form

C42892 C42890 C43451

BAR, CHEWABLE BEAD BEAD, IMPLANT, EXTENDED RELEASE

Chewable Bar Dosage Form Bead Dosage Form Extended Release Bead Implant Dosage Form

C42891 C97197 C25158

BLOCK CAPLET CAPSULE cap

Block Dosage Form Caplet Dosage Form Capsule Dosage Form

A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. (NCI)

C42895

CAPSULE, COATED

Coated Capsule Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 92 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42896

CDISC Submission Value CAPSULE, COATED PELLETS

CDISC Definition A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. (NCI) A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. (NCI) A substance that serves to produce solid union between two surfaces. (NCI)

NCI Preferred Term Coated Pellets in Capsule Dosage Form

C42917

CAPSULE, COATED, EXTENDED RELEASE

Extended Release Coated Capsule Dosage Form

C42902

CAPSULE, DELAYED RELEASE

Delayed Release Capsule Dosage Form

C42904

CAPSULE, DELAYED RELEASE PELLETS

Delayed Release Pellets in Capsule Dosage Form

C42916

CAPSULE, EXTENDED RELEASE

Extended Release Capsule Dosage Form

C42928

CAPSULE, FILM COATED, EXTENDED RELEASE

Extended Release Film Coated Capsule Dosage Form

C42936

CAPSULE, GELATIN COATED

Gelatin Coated Capsule Dosage Form

C42954

CAPSULE, LIQUID FILLED

Liquid Filled Capsule Dosage Form

C45414

CEMENT

Cement Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 93 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42678

CDISC Submission Value CIGARETTE

CDISC Definition A narrow tube filled with material that is capable to burn with release of therapeutically-active substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler system for fast-acting substances.(FDA) A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. (FDA) A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration. (NCI) A solid dosage form bounded by a circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva after a dental extraction. (NCI) An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period. (NCI) A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. The propagation of microorganisms or of living tissue cells in special media conducive to their growth. (NCI) A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection. (NCI) A circular plate-like organ or structure. (FDA) A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents. (NCI) The application of various materials for protecting a wound.(FDA) Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. (FDA)

NCI Preferred Term Cigarette Dosage Form

C60884

CLOTH

Cloth Dosage Form

C60891

CONCENTRATE

Concentrate Dosage Form

C42900

CONE

Cone Dosage Form

C42919

CORE, EXTENDED RELEASE CREAM

Extended Release Core Dosage Form Cream Dosage Form

C28944

C60897

CREAM, AUGMENTED

Augmented Cream Dosage Form

C42901

CRYSTAL

Crystal Dosage Form

C45415 C47890

CULTURE DIAPHRAGM

Culture Dosage Form Diaphragm Dosage Form

C43525 C42679

DISC DOUCHE

Disc Dosage Form Douche Dosage Form

C42763 C17423

DRESSING DRUG DELIVERY SYSTEM

Dressing Dosage Form Drug Delivery System

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 94 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42912

CDISC Submission Value ELIXIR

CDISC Definition A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. (NCI) A dosage form consisting of a two-phase system comprised of at least two immiscible liquids (1), one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment. (NCI) A rectal preparation for therapeutic, diagnostic, or nutritive purposes. (NCI) A concentrated preparation of vegetable or animal drugs obtained by removal of the active constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of the solvent, and adjustment of the residual masses or powders to the prescribed standards. (NCI) A slender and elongated solid thread-like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) A thin layer or coating. (NCI) A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue. (NCI) A thin layer or coating which is susceptible to being dissolved when in contact with a liquid. (NCI) A product, usually a solid, intended for solution prior to administration. (FDA) A product, usually a solid, intended for suspension prior to administration. (FDA) A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period. (FDA) Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI)

NCI Preferred Term Elixir Dosage Form

C42913

EMULSION

Emulsion Dosage Form

C42915 C42929

ENEMA EXTRACT

Enema Dosage Form Extract Dosage Form

C60926

FIBER, EXTENDED RELEASE

Extended Release Fiber Dosage Form

C42932 C42920

FILM FILM, EXTENDED RELEASE

Film Dosage Form Extended Release Film Dosage Form

C42984 C60927 C60928 C60929

FILM, SOLUBLE FOR SOLUTION FOR SUSPENSION FOR SUSPENSION, EXTENDED RELEASE

Soluble Film Dosage Form Dosage Form For Solution Dosage Form For Suspension Extended Release Dosage Form For Suspension

C42933

GAS

Gas Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 95 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42934

CDISC Submission Value GEL

CDISC Definition A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (NCI) A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth. (NCI) A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. (FDA) An apparatus for the formation of vapor or gas from a liquid or solid by heat or chemical action. The term GENERATOR also applies to radioactive columns from which radionuclides are provided. (NCI) Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade. (NCI) A slip of skin or of other tissue for implantation. (NCI) A small particle or grain. (NCI) A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines. (NCI) A small particle or grain containing a medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the capability to release gas, resulting in effervescence. (NCI) A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. (NCI) A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. (NCI)

NCI Preferred Term Gel Dosage Form

C42906

GEL, DENTIFRICE

Dentifrice Gel Dosage Form

C60930

GEL, METERED

Metered Gel Dosage Form

C48193

GENERATOR

Generator Dosage Form

C42937

GLOBULE

Globule Dosage Form

C45416 C42938 C42903

GRAFT GRANULE GRANULE, DELAYED RELEASE GRANULE, EFFERVESCENT

Graft Dosage Form Granule Dosage Form Delayed Release Granule Dosage Form Effervescent Granule Dosage Form

C42909

C42939

GRANULE, FOR SOLUTION

Granule For Solution Dosage Form

C42940

GRANULE, FOR SUSPENSION

Granule For Suspension Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 96 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42921

CDISC Submission Value GRANULE, FOR SUSPENSION, EXTENDED RELEASE

CDISC Definition A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue. (NCI) A mucilaginous excretion from various plants. (NCI) A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity. (NCI) Natural mixture of gum and resin, usually obtained as exudations from plants. (NCI) A material containing drug intended to be inserted securely and deeply in a living site for growth, slow release, or formation of an organic union. (NCI) A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure, can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler. (NCI) An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). (FDA) A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP. (NCI) An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.(FDA) [definition pending](FDA) A sterile preparation intended for reconstitution to form a solution for parenteral use. (NCI) A sterile preparation intended for reconstitution to form a suspension for parenteral use. (NCI) A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution).(FDA) A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would allow liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution. (NCI)

NCI Preferred Term Extended Release Granule For Suspension Dosage Form

C42941 C42894

GUM GUM, CHEWING

Gum Dosage Form Chewing Gum Dosage Form

C42978 C42942

GUM, RESIN IMPLANT

Resin Gum Dosage Form Implant Dosage Form

C42944

INHALANT

Inhalant Dosage Form

C60931

INJECTABLE, LIPOSOMAL

Liposomal Injection Dosage Form

C42946

INJECTION

Injectable Dosage Form

C42914

INJECTION, EMULSION

Emulsion for Injection Dosage Form

C42950 C42974 C42976 C42977

INJECTION, LIPID COMPLEX INJECTION, POWDER, FOR SOLUTION INJECTION, POWDER, FOR SUSPENSION INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE

Injectable Lipid Complex Dosage Form Powder For Injectable Solution Dosage Form Powder For Injectable Suspension Dosage Form Powder For Injectable Extended Release Suspension Dosage Form

C42959

INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION

Lyophilized Powder For Injectable Liposomal Suspension Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 97 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42957

CDISC Submission Value INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

CDISC Definition A dosage form intended for the solution prepared by lyophilization ('freeze drying'), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections. (NCI) A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. (NCI) A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). (NCI) A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection. (NCI) A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections. (NCI) A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa. (NCI) A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) A liquid parenteral pharmaceutical dosage form structured as a multilamellar composition of concentric phospholipid spheres that encapsulate the drug (drug delivery systems) separated by layers of water. Drug release is facilitated and controlled by in vivo erosion of the liposomes. To further increase the in vivo circulation time, liposomes in some preparations are covalently derivatized with PEG to produce PEGylated or stealth liposomes. Covalent attachment of drugs to the outer surface of liposomes can potentially serve as a delayed-release product. (NCI)

NCI Preferred Term Lyophilized Powder For Injectable Solution Dosage Form

C42958

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Lyophilized Powder For Injectable Suspension Dosage Form

C42956

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE

Lyophilized Powder For Extended Release Injectable Suspension Dosage Form

C42945

INJECTION, SOLUTION

Injectable Solution Dosage Form

C42899

INJECTION, SOLUTION, CONCENTRATE

Concentrate for Injectable Solution Dosage Form

C42995

INJECTION, SUSPENSION

Injectable Suspension Dosage Form

C42926

INJECTION, SUSPENSION, EXTENDED RELEASE

Injectable Extended Release Suspension Dosage Form

C42951

INJECTION, SUSPENSION, LIPOSOMAL

Injectable Liposomal Suspension Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 98 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42988

CDISC Submission Value INJECTION, SUSPENSION, SONICATED

CDISC Definition A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles. (NCI) A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. (FDA) A specially formulated and shaped solid preparation (e.g., ring, tablet, or stick) intended to be placed in the vagina by special inserters, where the medication is released, generally for localized effects; the extended release preparation is designed to allow a reduction in dosing frequency. (NCI) A device inserted and left in the uterus to prevent effective conception. (NCI) A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally. (NCI) A class of gels--semisolid systems which consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water. (NCI) A packaged collection of related material. (NCI) A material applied to the inside of the dental cavity, for protection or insulation of the surface.(FDA) A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application. (NCI) A waxy solid, usually colored cosmetic, in stick form for the lips. (NCI) A dosage form consisting of a pure chemical in its liquid state. This dosage form term should not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA)

NCI Preferred Term Injectable Sonicated Suspension Dosage Form

C60933

INSERT

Insert Dosage Form

C42922

INSERT, EXTENDED RELEASE

Extended Release Insert Dosage Form

C47915 C42947

INTRAUTERINE DEVICE IRRIGANT

Intrauterine Device Dosage Form Irrigant Dosage Form

C42948

JELLY

Jelly Dosage Form

C47916 C45413 C42949

KIT LINER, DENTAL LINIMENT

Kit Dosage Form Dental Liner Dosage Form Liniment Dosage Form

C42952 C42953

LIPSTICK LIQUID

Lipstick Dosage Form Liquid Dosage Form

C60934

LIQUID, EXTENDED RELEASE

A liquid that delivers a drug in such a manner to allow a Extended Release Liquid Dosage reduction in dosing frequency as compared to that drug Form (or drugs) presented as a conventional dosage form. (FDA)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 99 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C29167

CDISC Submission Value LOTION

CDISC Definition An emulsion, liquid (1) dosage form. This dosage form is generally for external application to the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the definition of a lotion was: The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin. The current definition of a lotion is restricted to an emulsion. (FDA) A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. (FDA) A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.(FDA) An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect. (NCI) The use of a dosage form term is not relevant or appropriate. (NCI) An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. (NCI)

NCI Preferred Term Lotion Dosage Form

C60957

LOTION, AUGMENTED

Augmented Lotion Dosage Form

C60958

LOTION/SHAMPOO

Lotion Shampoo Dosage Form

C42955

LOZENGE

Lozenge Dosage Form

C29269 C48624 C42965

MOUTHWASH NOT APPLICABLE OIL

Mouthwash Dosage Form Dosage Form Not Applicable Oil Dosage Form

C42966

OINTMENT

oint

A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (NCI) An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or between the tooth enamel and the gingival margin.(FDA)

Ointment Dosage Form

C60984

OINTMENT, AUGMENTED

Augmented Ointment Dosage Form

C47887

PACKING

Packing Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 100 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42967

CDISC Submission Value PASTE

CDISC Definition A semisolid dosage form, containing a large proportion (20 - 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. (NCI) A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. (FDA) A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (NCI) A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) A drug delivery system in the form of a patch which is controlled by an electric current that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding. (NCI) A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. (NCI) A solid dosage form in which the drug itself is in the form of granules to which varying amounts of coating have been applied, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) A dose of medicine in the form of a small pellet. (NCI)

NCI Preferred Term Paste Dosage Form

C42907

PASTE, DENTIFRICE

Dentifrice Paste Dosage Form

C60985 C42968

PASTILLE PATCH

Pastille Dosage Form Patch Dosage Form

C42923

PATCH, EXTENDED RELEASE

Extended Release Patch Dosage Form

C42911

PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED

Electrically Controlled Extended Release Patch Dosage Form

C42969

PELLET

Pellet Dosage Form

C42943

PELLET, IMPLANTABLE

Implantable Pellet Dosage Form

C42918

PELLETS, COATED, EXTENDED RELEASE

Extended Release Coated Pellets Dosage Form

C25394

PILL

Pill Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 101 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42970

CDISC Submission Value PLASTER

CDISC Definition Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. (NCI) A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency. (NCI) An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. (NCI) An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle). (NCI) A powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity. (NCI) A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. (FDA) A liquid used to cleanse by flushing. (NCI) A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster). (NCI) A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. (NCI) A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. (NCI) Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic. (NCI)

NCI Preferred Term Plaster Dosage Form

C47913

POULTICE

Poultice Dosage Form

C42972

POWDER

Powder Dosage Form

C42908

POWDER, DENTIFRICE

Dentifrice Powder Dosage Form

C42973

POWDER, FOR SOLUTION

Powder for Solution Dosage Form

C42975

POWDER, FOR SUSPENSION

Powder for Suspension Dosage Form

C42961

POWDER, METERED

Metered Powder Dosage Form

C60988

RING

Ring Dosage Form

C42979 C42980

RINSE SALVE

Rinse Dosage Form Salve Dosage Form

C42981

SHAMPOO

Shampoo Dosage Form

C42982

SHAMPOO, SUSPENSION

Shampoo Suspension Dosage Form

C42983

SOAP

Soap Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 102 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42986

CDISC Submission Value SOLUTION

CDISC Definition A clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (NCI) A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its non-active parts. (NCI) A solution for the preparation of an iced saline slush, which is administered by irrigation and used to induce regional hypothermia (in conditions such as certain open heart and kidney surgical procedures) by its direct application. (NCI) A solution, which after usually being administered in a drop-wise fashion, forms a gel. (FDA) A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency. (FDA) A solution which is usually administered in a drop-wise fashion. (FDA) A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.(FDA) A liquid minutely divided as by a jet of air or steam. (NCI) A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. (NCI) A liquid preparation containing solid particles dispersed in a liquid vehicle and in the form of coarse droplets or as finely divided solids to be applied locally, most usually to the nasal-pharyngeal tract, or topically to the skin. (NCI) A dosage form prepared in a relatively long and slender often cylindrical form. (NCI) A long narrow piece of material.

NCI Preferred Term Solution Dosage Form

C42898

SOLUTION, CONCENTRATE

Concentrate for Solution Dosage Form

C42987

SOLUTION, FOR SLUSH

Solution For Slush Dosage Form

C60994 C42935

SOLUTION, GEL FORMING / DROPS SOLUTION, GEL FORMING, EXTENDED RELEASE SOLUTION/ DROPS SPONGE

Gel Forming Drops Solution Dosage Form Extended Release Gel Forming Solution Dosage Form Drops Solution Dosage Form Sponge Dosage Form

C60992 C47912

C42989 C42962

SPRAY SPRAY, METERED

Spray Dosage Form Metered Spray Dosage Form

C42990

SPRAY, SUSPENSION

Spray Suspension Dosage Form

C42991 C47914 C42993

STICK STRIP SUPPOSITORY supp

Stick Dosage Form Strip Dosage Form Suppository Dosage Form

A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. (NCI) A drug delivery system in the form of a suppository that allows at least a reduction in dosing frequency. (NCI)

C42924

SUPPOSITORY, EXTENDED RELEASE

Extended Release Suppository Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 103 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym susp

NCI Code C42994

CDISC Submission Value SUSPENSION

CDISC Definition A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA) A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) A suspension which is usually administered in a dropwise fashion. (FDA) A strand or fiber used to hold wound edges in apposition during healing. (NCI) A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. (NCI) An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. (NCI)

NCI Preferred Term Suspension Dosage Form

C42925

SUSPENSION, EXTENDED RELEASE

Extended Release Suspension Dosage Form

C60995 C47889 C47898

SUSPENSION/DROPS SUTURE SWAB

Drops Suspension Dosage Form Suture Dosage Form Swab Dosage Form

C42996

SYRUP

Syrup Dosage Form

C42998 C42893

TABLET TABLET, CHEWABLE

tab

A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste. (NCI) A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. (NCI) A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. (FDA) A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI) A solid dosage form containing a conglomerate of medicinal particles that have been covered with a coating which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI)

Tablet Dosage Form Chewable Tablet Dosage Form

C42897

TABLET, COATED

Coated Tablet Dosage Form

C60997

TABLET, COATED PARTICLES TABLET, DELAYED RELEASE

Tablet Coated Particles Dosage Form Delayed Release Tablet Dosage Form

C42905

C42997

TABLET, DELAYED RELEASE PARTICLES

Delayed Release Particles Tablet Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 104 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C42910

CDISC Submission Value TABLET, EFFERVESCENT

CDISC Definition A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.(FDA) A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form. (NCI) A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer. (NCI) A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. (NCI) A tablet that forms a solution when placed in a liquid. (FDA) A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible Tablet). A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell. (NCI) A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. (NCI) A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. (NCI) A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. (FDA) A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids. (NCI) A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar. (NCI)

NCI Preferred Term Effervescent Tablet Dosage Form

C42927

TABLET, EXTENDED RELEASE TABLET, FILM COATED

Extended Release Tablet Dosage Form Film Coated Tablet Dosage Form

C42931

C42930

TABLET, FILM COATED, EXTENDED RELEASE

Film Coated Extended Release Tablet Dosage Form

C61004 C61005 C42964

TABLET, FOR SOLUTION TABLET, FOR SUSPENSION TABLET, MULTILAYER

Tablet For Solution Dosage Form Tablet For Suspension Dosage Form Multilayered Tablet Dosage Form

C42963

TABLET, MULTILAYER, EXTENDED RELEASE

Multilayered Extended Release Tablet Dosage Form

C42999

TABLET, ORALLY DISINTEGRATING TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Orally Disintegrating Tablet Dosage Form Tablet Orally Disintegrating Delayed Release Dosage Form

C61006

C42985

TABLET, SOLUBLE

Soluble Tablet Dosage Form

C42992

TABLET, SUGAR COATED

Sugar Coated Tablet Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 105 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66726 - FRM - Pharmaceutical Dosage Form Codelist extensible: Yes
CDISC Synonym

NCI Code C47892

CDISC Submission Value TAMPON

CDISC Definition A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions. (NCI) A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides. (NCI) An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances. (NCI) A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients. (NCI) A dosage form has yet to be assigned. (NCI) A thin slice of material containing a medicinal agent. (NCI)

NCI Preferred Term Tampon Dosage Form

C47897

TAPE

Tape Dosage Form

C43000

TINCTURE

Tincture Dosage Form

C43001

TROCHE

Troche Dosage Form

C43002 C43003

UNASSIGNED WAFER

Unassigned Dosage Form Wafer Dosage Form

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 106 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101853 - GRSTNLOC - Location of Most Severe Stenosis Within a Graft Codelist extensible: No
CDISC Synonym

NCI Code C99915 C99918 C80476

CDISC Submission Value AORTIC ANASTOMOSIS OF THE GRAFT BODY OF THE GRAFT

CDISC Definition The connection where the graft joins the aorta usually less than or equal to 3 mm from insertion point. The portion of the graft that lies between its anastomoses. The connection where the graft joins the coronary artery usually less than or equal to 3 mm from insertion point.

NCI Preferred Term Aortic Anastomosis of Graft Body of Graft Coronary Graft Anastomoses

CORONARY ANASTOMOSIS Coronary Graft OF THE GRAFT Anastomoses

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 107 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66797 - IECAT - Category for Inclusion/Exclusion Codelist extensible: No
CDISC Synonym

NCI Code C25370

CDISC Submission Value EXCLUSION

CDISC Definition List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (CDISC glossary) The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. (CDISC glossary)

NCI Preferred Term Exclusion Criteria

C25532

INCLUSION

Inclusion Criteria

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 108 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99076 - INTMODEL - Intervention Model Codelist extensible: Yes
CDISC Synonym

NCI Code C82637

CDISC Submission Value CROSS-OVER

CDISC Definition Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study. Two or more interventions, each alone and in combination, are evaluated in parallel against a control group. Participants are assigned to one of two or more arms in parallel for the duration of the study. Single arm study.

NCI Preferred Term Crossover Study

C82638

FACTORIAL

Factorial Study

C82639 C82640

PARALLEL SINGLE GROUP

Parallel Study Single Group Study

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 109 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99078 - INTTYPE - Intervention Type Codelist extensible: No
CDISC Synonym

NCI Code C15184

CDISC Submission Value BEHAVIORAL THERAPY

CDISC Definition A technique used to change subjects' behavior, for example, psychotherapy, lifestyle counseling or hypnosis. A substance made from living organisms or things they produce, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (FDA) Oral preparations containing dietary ingredient(s) intended to supplement the diet. Dietary ingredients include vitamins, minerals, herbs, amino acids, extracts and metabolites. An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient (21 CFR 314.3(b)). Application of genetic material into cells in order to correct an inherited or acquired disease.

NCI Preferred Term Behavioral Intervention

C307

BIOLOGIC

Biological Agent

C16830

DEVICE

Medical Device

C1505

DIETARY SUPPLEMENT

Nutritional Supplement

C1909

DRUG

Pharmacologic Substance

C15238 C17649 C98769

GENETIC OTHER PROCEDURE Other

Gene Therapy Other Physical Medical Procedure

Different than the one(s) previously specified or mentioned. (NCI) A treatment procedure performed by manual and/or instrumental means, for example: surgery, lithotripsy, or external manipulation. Treatment of a disease by means of exposure of the target or the whole body to radiation.

C15313

RADIATION

Radiation Therapy

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 110 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101854 - KILLIPC - Killip Class Responses Codelist extensible: No
CDISC Synonym

NCI Code C77269 C77270

CDISC Submission Value Killip CLASS I Killip CLASS II

CDISC Definition The absence of rales over the lung fields and absence of third heart sound (S3). (ACC/AHA) The presence of rales over 50% or less of the lung fields or the presence of a third heart sound (S3).(ACC/AHA) The presence of rales over more than 50% of the lung fields. (ACC/AHA) The presence of cardiogenic shock (systolic BP less than 90 mm Hg) for greater than 30 minutes, not responsive to fluid resuscitation alone, and felt to be secondary to cardiac dysfunction. (ACC/AHA)

NCI Preferred Term Killip Class I Killip Class II

C77271 C77272

Killip CLASS III Killip CLASS IV

Killip Class III Killip Class IV

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 111 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99073 - LAT - Laterality Codelist extensible: Yes
CDISC Synonym

NCI Code C13332 C25307 C25308 C25230 C25229 C25228 C28012

CDISC Submission Value BILATERAL CONTRALATERAL IPSILATERAL LATERAL LEFT RIGHT UNILATERAL

CDISC Definition Affecting both sides of the body, or a pair of organs. Having to do with the opposite side of the body, in relation to a pre-existing reference point. Having to do with the same side of the body, in relation to a pre-existing reference point. Situated at or extending to the side. Being or located on or directed toward the side of the body to the west when facing north. Being or located on or directed toward the side of the body to the east when facing north. Affecting one side of the body or one of a pair of organs.

NCI Preferred Term Bilateral Contralateral Ipsilateral Lateral Left Right Unilateral

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 112 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym 1, 25-Dihydroxyvit amin D; Active Vitamin D 25-Hydroxyvita min D; Inactive Vitamin D 3,4-Dihydroxyph enylglycol; 3.4 Dihydroxyphenyl glycol 5 Prime Nucleotidase; 5'-Ribonucleotid e Phosphohydrolas e 6-Monoacetylmo rphine A Fetoprotein L3/A Fetoprotein ADV Viral Load Acanthocytes Acanthocytes/ Erythrocytes Acetoacetic Acid; Acetoacetate Acetylcholine Acetylcholine Receptor Antibody Acetylcholineste rase Acid Phosphatase Acid Urate Crystals Activated PTT/Standard

NCI Code C92267

CDISC Submission Value 1, 25-Dihydroxyvitamin D

CDISC Definition A measurement of the total active Vitamin D in a biological specimen.

NCI Preferred Term 1, 25-Dihydroxyvitamin D Measurement

C92268

25-Hydroxyvitamin D

A measurement of the total inactive Vitamin D in a biological specimen. A measurement of the catecholamine metabolite, 3,4-Dihydroxyphenylglycol in a biological specimen.

25-Hydroxyvitamin D Measurement

C101017

3,4-Dihydroxyphenylglycol

3,4-Dihydroxyphenylglycol Measurement

C79437

5 Prime Nucleotidase

A measurement of the 5'-nucleotidase in a biological specimen.

5 Prime Nucleotidase Measurement

C74876 C96565

6-Monoacetylmorphine A Fetoprotein L3/A Fetoprotein ADV Viral Load Acanthocytes Acanthocytes/Erythrocytes

A measurement of the 6-monoacetylmorphine present in a biological specimen. A relative measurement (ratio or percentage) of alpha fetoprotein L3 to total alpha fetoprotein in a biological specimen. A measurement of the adenovirus viral load in a biological specimen. A measurement of the acanthocytes in a biological specimen. A relative measurement (ratio or percentage) of acanthocytes to all erythrocytes in a biological specimen. A measurement of the acetoacetic acid in a biological specimen. A measurement of the acetylcholine hormone in a biological specimen. A measurement of the acetylcholine receptor antibody in a biological specimen. A measurement of the acetylcholinesterase in a biological specimen. A measurement of the acid phosphatase in a biological specimen. A measurement of the acid urate crystals present in a biological specimen. A relative measurement (ratio or percentage) of the subject's partial thromboplastin time to a standard or control partial thromboplastin time.

6-Monoacetylmorphine Measurement Alpha Fetoprotein L3 to Total Alpha Fetoprotein Ratio Measurement Adenovirus Viral Load Measurement Acanthocyte Count Acanthocyte to Erythrocyte Ratio Measurement Acetoacetic Acid Measurement

C98705 C74699 C74633

C92247

Acetoacetic Acid

C74838 C96559

Acetylcholine Acetylcholine Receptor Antibody Acetylcholinesterase Acid Phosphatase Acid Urate Crystals Activated PTT/Standard

Acetylcholine Measurement Acetylcholine Receptor Antibody Measurement Acetylcholinesterase Measurement Acid Phosphatase Measurement Acid Urate Crystal Measurement Activated PTT/Standard Ratio Measurement

C96560 C80163 C74912 C98862

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 113 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Activated PTT/Standard PTT; Activated Partial Thromboplastin Time/Standard Thromboplastin Time Activated Partial Thromboplastin Time Activated Protein C Resistance; Factor V Leiden Screen Acyl Coenzyme A Oxidase; Fatty Acyl Coenzyme A Oxidase; Acyl CoA Oxidase Adenosine Diphosphate Adiponectin Adrenocorticotr opic Hormone Alanine Aminopeptidase Alanine Aminotransferas e; SGPT Albumin; Microalbumin Albumin/ Creatinine; Microalbumin/ Creatinine Ratio Albumin/ Globulin Aldolase Aldosterone Alkaline Phosphatase Alkaline Phosphatase/ Creatinine

NCI Code C100421

CDISC Submission Value Activated PTT/Standard PTT

CDISC Definition A relative measurement (ratio or percentage) of the subject's activated partial thromboplastin time to a standard or control partial thromboplastin time.

NCI Preferred Term Activated PTT to Standard PTT Ratio Measurement

C38462

Activated Partial Thromboplastin Time

A measurement of the length of time that it takes for clotting to occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. A measurement of the resistance in the anticoagulation response to activated protein C in a biological specimen. A measurement of the acyl coenzyme A oxidase in a biological specimen.

Partial Thromboplastin Time

C100471

Activated Protein C Resistance

Activated Protein C Resistance Measurement

C92286

Acyl Coenzyme A Oxidase

Acyl Coenzyme A Oxidase Measurement

C102257 C74839 C74780 C100430 C64433

Adenosine Diphosphate Adiponectin Adrenocorticotropic Hormone Alanine Aminopeptidase Alanine Aminotransferase

A measurement of the adenosine diphosphate in a biological specimen. A measurement of the adiponectin hormone in a biological specimen. A measurement of the adrenocorticotropic hormone in a biological specimen. A measurement of the alanine aminopeptidase in a biological specimen. A measurement of the alanine aminotransferase in a biological specimen. A measurement of the albumin protein in a biological specimen. A relative measurement (ratio or percentage) of the albumin to the creatinine in a biological specimen.

Adenosine Diphosphate Measurement Adiponectin Measurement Adrenocorticotropic Hormone Measurement Alanine Aminopeptidase Measurement Alanine Aminotransferase Measurement Albumin Measurement Albumin To Creatinine Protein Ratio Measurement

C64431 C74761

Albumin Albumin/Creatinine

C74894 C74731 C74841 C64432 C79438

Albumin/Globulin Aldolase Aldosterone Alkaline Phosphatase Alkaline Phosphatase/Creatinine

The ratio of albumin to globulin in a biological specimen. A measurement of the aldolase enzyme in a biological specimen. A measurement of the aldosterone hormone in a biological specimen. A measurement of the alkaline phosphatase in a biological specimen. A relative measurement (ratio or percentage) of the alkaline phosphatase to creatinine in a biological specimen.

Albumin to Globulin Ratio Measurement Aldolase Measurement Aldosterone Measurement Alkaline Phosphatase Measurement Alkaline Phosphatase to Creatinine Ratio Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 114 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Alpha Fetoprotein Alpha Fetoprotein L1 Alpha Fetoprotein L2 Alpha Fetoprotein L3 Alpha Glutathione-S-Tr ansferase Alpha-1 Acid Glycoprotein Alpha-1 Antitrypsin; Serum Trypsin Inhibitor Alpha-1 Globulin; A1-Globulin Alpha-1 Globulin/Total Protein Alpha-1 Microglobulin; Protein HC Alpha-1 Microglobulin/ Creatinine Alpha-2 Globulin; A2-Globulin Alpha-2 Globulin/Total Protein Alpha-2 Macroglobulin Ammonia; NH3 Ammonium Biurate Crystals; Ammonium Urate Crystals; Acid Ammonium Urate Crystals Ammonium Oxalate Crystals

NCI Code C74732 C96562 C96563 C96564 C79433

CDISC Submission Value Alpha Fetoprotein Alpha Fetoprotein L1 Alpha Fetoprotein L2 Alpha Fetoprotein L3 Alpha Glutathione-S-Transferase Alpha-1 Acid Glycoprotein Alpha-1 Antitrypsin

CDISC Definition A measurement of the alpha fetoprotein in a biological specimen. A measurement of the alpha fetoprotein L1 in a biological specimen. A measurement of the alpha fetoprotein L2 in a biological specimen. A measurement of the alpha fetoprotein L3 in a biological specimen. A measurement of the alpha form of glutathione S-transferase in a biological specimen. A measurement of the alpha-1 acid glycoprotein in a biological specimen. A measurement of the alpha-1 antitrypsin in a biological specimen.

NCI Preferred Term Alpha-fetoprotein Measurement Alpha Fetoprotein L1 Measurement Alpha Fetoprotein L2 Measurement Alpha Fetoprotein L3 Measurement Alpha Glutathione-S-Transferase Measurement Alpha-1 Acid Glycoprotein Measurement Alpha-1 Antitrypsin Measurement

C100429 C80167

C92252

Alpha-1 Globulin

A measurement of the proteins contributing to the alpha 1 fraction in a biological specimen. A relative measurement (ratio or percentage) of alpha-1-fraction proteins to total proteins in a biological specimen. A measurement of the alpha-1 microglobulin in a biological specimen. A relative measurement (ratio or percentage) of the alpha-1 microglobulin to creatinine in a biological specimen. A measurement of the proteins contributing to the alpha 2 fraction in a biological specimen. A relative measurement (ratio or percentage) of alpha-2-fraction proteins to total proteins in a biological specimen. A measurement of the alpha-2 macroglobulin in a biological specimen. A measurement of the ammonia in a biological specimen. A measurement of the ammonium biurate crystals present in a biological specimen.

Alpha-1 Globulin Measurement

C92253

Alpha-1 Globulin/Total Protein Alpha-1 Microglobulin

Alpha-1 Globulin to Total Protein Ratio Measurement Alpha-1 Microglobulin Measurement

C100461

C100462

Alpha-1 Microglobulin/Creatinine Alpha-2 Globulin

Alpha-1 Microglobulin to Creatinine Ratio Measurement Alpha-2 Globulin Measurement

C92254

C92255

Alpha-2 Globulin/Total Protein Alpha-2 Macroglobulin Ammonia Ammonium Biurate Crystals

Alpha-2 Globulin to Total Protein Ratio Measurement Alpha-2 Macroglobulin Measurement Ammonia Measurement Urine Ammonium Biurate Crystal Measurement

C80168 C74799 C74758

C74759

Ammonium Oxalate Crystals

A measurement of the ammonium oxalate crystals present in a urine specimen.

Urine Ammonium Oxalate Crystal Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 115 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Amorphous Crystals Amorphous Phosphate Crystals Amorphous Sediment; Amorphous Debris Amorphous Urate Crystals Amphetamine Amylase Amylase, Pancreatic Amylase, Salivary Amyloid Beta 42; Amyloid Beta 42 Protein Amyloid P Amyloid, Beta; Beta Amyloid Androstenediol Androstenedione ; 4-Androstenedio ne Angiotensin Converting Enzyme Angiotensin I Angiotensin II Angiotensinogen; Angiotensin Precursor Anion Gap

NCI Code C74665

CDISC Submission Value Amorphous Crystals

CDISC Definition A measurement of the amorphous (Note: phosphate or urate, depending on pH) crystals present in a biological specimen. A measurement of the amorphous phosphate crystals in a biological specimen. A measurement of the amorphous sediment present in a biological specimen.

NCI Preferred Term Amorphous Crystal Measurement

C92243

Amorphous Phosphate Crystals Amorphous Sediment

Amorphous Phosphate Crystals Measurement Amorphous Sediment Measurement

C74666

C92244 C74687 C64434 C98767 C98780 C84809

Amorphous Urate Crystals Amphetamine Amylase Amylase, Pancreatic Amylase, Salivary Amyloid Beta 42

A measurement of the amorphous urate crystals in a biological specimen. A measurement of any amphetamine class drug present in a biological specimen. A measurement of the total enzyme amylase in a biological specimen. A measurement of the pancreatic enzyme amylase in a biological specimen. A measurement of the salivary enzyme amylase in a biological specimen. A measurement of the 42 amino acid amyloid beta protein isoform in a biological specimen. A measurement of the total amyloid P in a biological specimen. A measurement of the total amyloid beta in a biological specimen. A measurement of the androstenediol metabolite in a biological specimen. A measurement of the androstenedione hormone in a biological specimen.

Amorphous Urate Crystals Measurement Amphetamine Drug Class Measurement Amylase Measurement Pancreatic Amylase Measurement Salivary Amylase Measurement Beta Amyloid 42 Measurement

C81998 C81999 C74842 C74843

Amyloid P Amyloid, Beta Androstenediol Androstenedione

Amyloid P Measurement Beta Amyloid Measurement Androstenediol Metabolite Measurement Androstenedione Measurement

C80169

Angiotensin Converting Enzyme Angiotensin I Angiotensin II Angiotensinogen

A measurement of the angiotensin converting enzyme in a biological specimen. A measurement of the angiotensin I hormone in a biological specimen. A measurement of the angiotensin II hormone in a biological specimen. A measurement of the angiotensinogen hormone in a biological specimen. A computed estimate of the unmeasured anions (those other than the chloride and bicarbonate anions) in a biological specimen.

Angiotensin Converting Enzyme Measurement Angiotensin I Measurement Angiotensin II Measurement Angiotensinogen Measurement

C74844 C74845 C74846

C74685

Anion Gap

Anion Gap Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 116 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Anisocytes Anti-DNA Antibodies; Anti-ds-DNA Antibodies Anti-Double Stranded DNA Anti-Factor Xa Activity

NCI Code C74797 C81973

CDISC Submission Value Anisocytes Anti-DNA Antibodies

CDISC Definition A measurement of the inequality in the size of the red blood cells in a whole blood specimen. A measurement of the anti-DNA antibodies in a biological specimen.

NCI Preferred Term Anisocyte Measurement Anti-DNA Antibody Measurement

C74913 C98706

Anti-Double Stranded DNA Anti-Factor Xa Activity

A measurement of the anti-double stranded DNA antibody in a biological specimen. A measurement of the anti-activated Factor X in a biological specimen. This test is used to monitor low molecular weight or unfractionated heparin levels in a biological specimen. A measurement of the anti-Saccharomyces cerevisiae antibody in a biological specimen. A measurement of the anti-single stranded DNA IgG antibody in a biological specimen. A measurement of any antidepressant class drug present in a biological specimen. A measurement of the antidiuretic hormone in a biological specimen. A measurement of the antibody or complement-coated erythrocytes in a biological specimen in vivo.

Anti-Double Stranded DNA Measurement Anti-Factor Xa Activity Measurement

C81976

Anti-Saccharomyces cerevisiae Antibody

Anti-Saccharomy ces cerevisiae Antibody

Anti-Saccharomyces cerevisiae Antibody Measurement Anti-Single Stranded DNA IgG Measurement Antidepressant Measurement Antidiuretic Hormone Measurement

C92269

Anti-Single Stranded DNA IgG Anti-Single Stranded DNA IgG Antidepressants Antidiuretic Hormone Antidepressants Antidiuretic Hormone; Vasopressin Antiglobulin Test, Direct; Direct Coombs Test Antimitochondri al Antibodies; Mitochondrial Antibody Antinuclear Antibodies Antiphospholipid Antibodies Antithrombin; Antithrombin III; Antithrombin Activity; Antithrombin III Activity Antithrombin Antigen; Antithrombin III Antigen Apolipoprotein A1

C74691 C74847

C81974

Antiglobulin Test, Direct

Direct Antiglobulin Test

C81975

Antimitochondrial Antibodies

A measurement of the antimitochondrial antibodies in a biological specimen.

Antimitochondrial Antibody Measurement

C74916

Antinuclear Antibodies

A measurement of the antinuclear antibodies (antibodies that attack the body's own tissue) in a biological specimen. A measurement of the antiphospholipid antibodies in a biological specimen. A measurement of the antithrombin activity in a biological specimen.

Antinuclear Antibody Measurement

C102258 C81958

Antiphospholipid Antibodies Antithrombin

Antiphospholipid Antibody Measurement Antithrombin Measurement

C81977

Antithrombin Antigen

A measurement of the antithrombin antigen in a biological specimen.

Antithrombin Antigen Measurement

C74733

Apolipoprotein A1

A measurement of the apolipoprotein A1 in the high density lipoproteins of a biological specimen.

Apolipoprotein A1 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 117 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Apolipoprotein AII Apolipoprotein B Apolipoprotein C2; Apolipoprotein CII Apolipoprotein CIII Apolipoprotein E Apolipoprotein E4 Apolipoprotein H Apolipoprotein J; Clusterin Arachidonic Acid Aspartate Aminotransferas e; SGOT Aspartate Aminotransferas e Antigen; SGOT Antigen Atrial Natriuretic Peptide; Atriopeptin Auer Rods

NCI Code C82000 C74734 C100427

CDISC Submission Value Apolipoprotein AII Apolipoprotein B Apolipoprotein C2

CDISC Definition A measurement of the apolipoprotein AII in a biological specimen. A measurement of the apolipoprotein B in the low density lipoproteins of a biological specimen. A measurement of the apolipoprotein C2 in a biological specimen.

NCI Preferred Term Apolipoprotein AII Measurement Apolipoprotein B Measurement Apolipoprotein C2 Measurement

C82001 C82002 C92293 C82003 C100428 C102259 C64467

Apolipoprotein CIII Apolipoprotein E Apolipoprotein E4 Apolipoprotein H Apolipoprotein J Arachidonic Acid Aspartate Aminotransferase

A measurement of the apolipoprotein CIII in a biological specimen. A measurement of the apolipoprotein E in a biological specimen. A measurement of the apolipoprotein E4 in a biological specimen. A measurement of the apolipoprotein H in a biological specimen. A measurement of the apolipoprotein J in a biological specimen. A measurement of the arachidonic acid present in a biological specimen. A measurement of the aspartate aminotransferase in a biological specimen. A measurement of the aspartate aminotransferase antigen in a biological specimen.

Apolipoprotein CIII Measurement Apolipoprotein E Measurement Apolipoprotein E4 Measurement Apolipoprotein H Measurement Apolipoprotein J Measurement Arachidonic Acid Measurement Aspartate Aminotransferase Measurement Aspartate Aminotransferase Antigen Measurement

C81978

Aspartate Aminotransferase Antigen

C74886

Atrial Natriuretic Peptide

A measurement of the atrial natriuretic peptide in a biological specimen. A measurement of the Auer rods (elongated needle structures that are found in the cytoplasm of leukemic blasts and are formed by clumps of azurophilic granular material) in a biological specimen. A measurement of the BK virus viral load in a biological specimen. A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a biological specimen. A measurement of the bacteria in a biological specimen. A measurement of the bacterial casts present in a biological specimen. A measurement of any barbiturate class drug present in a biological specimen. A measurement of the basophilic stippling in a biological specimen.

Atrial Natriuretic Peptide Measurement Auer Rod Measurement

C74657

Auer Rods

C98710 C74753

BKV Viral Load BUN/Creatinine

BKV Viral Load BUN/Creatinine

BK Virus Viral Load Measurement Blood Urea Nitrogen To Creatinine Ratio Measurement Bacterial Count Bacterial Cast Measurement Barbiturate Drug Class Measurement Basophilic Stippling Measurement

C64469 C74762 C74688 C96567

Bacteria Bacterial Casts Barbiturates Basophilic Stippling

Bacteria Bacterial Casts Barbiturates Basophilic Stippling

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 118 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Basophils Basophils/ Leukocytes Basophils/Total Cells Benzodiazepine Benzoylecgonine ; Cocaine Metabolite Beta Carotene; b-Carotene; Beta Carotin Beta Globulin Beta Globulin/Total Protein Beta-2 Glycoprotein Antibody Beta-2 Microglobulin Beta-Hydroxybut yrate; B-Hydroxybutyra te; 3-Hydroxybutyra te Beta-Trace Protein Bicarbonate; HCO3 Bile Acid; Bile Salts; Bile Acids; Bile Salt Bilirubin; Total Bilirubin Bilirubin Crystals Bite Cells

NCI Code C64470 C64471 C98865

CDISC Submission Value Basophils Basophils/Leukocytes Basophils/Total Cells

CDISC Definition A measurement of the basophils in a biological specimen. A relative measurement (ratio or percentage) of the basophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the basophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of any benzodiazepine class drug present in a biological specimen. A measurement of the benzoylecgonine in a biological specimen. A measurement of the beta carotene in a biological specimen. A measurement of the proteins contributing to the beta fraction in a biological specimen. A relative measurement (ratio or percentage) of beta fraction proteins to total proteins in a biological specimen. A measurement of the beta-2 glycoprotein antibody in a biological specimen. A measurement of the beta-2 microglobulin in a biological specimen. A measurement of the total Beta-hydroxybutyrate in a biological specimen.

NCI Preferred Term Total Basophil Count Basophil To Leukocyte Ratio Basophil to Total CellRatio Measurement Benzodiazepine Measurement Benzoylecgonine Measurement

C74692 C75350

Benzodiazepine Benzoylecgonine

C100472

Beta Carotene

Beta Carotene Measurement

C92256 C92294

Beta Globulin Beta Globulin/Total Protein

Beta Globulin Measurement Beta Globulin to Total Protein Ratio Measurement Beta-2 Glycoprotein Antibody Measurement Beta-2 Microglobulin Measurement Beta-Hydroxybutyrate Measurement

C81979

Beta-2 Glycoprotein Antibody

C81980 C96568

Beta-2 Microglobulin Beta-Hydroxybutyrate

C100426 C74667 C74800

Beta-Trace Protein Bicarbonate Bile Acid

A measurement of the beta-trace protein in a biological specimen. A measurement of the bicarbonate in a biological specimen. A measurement of the total bile acids in a biological specimen. A measurement of the total bilirubin in a biological specimen. A measurement of the bilirubin crystals present in a biological specimen. A measurement of the bite cells (erythrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen .

Beta-Trace Protein Measurement Bicarbonate Measurement Bile Acid Measurement

C38037 C74668 C74700

Bilirubin Bilirubin Crystals Bite Cells

Total Bilirubin Measurement Bilirubin Crystal Measurement Bite Cell Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 119 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Bite Cells/ Erythrocytes Blasts Blasts/ Leukocytes Blood Urea Nitrogen Bone Specific Alkaline Phosphatase Brain Natriuretic Peptide; B-Type Natriuretic Peptide Brain-Derived Neurotrophic Factor Broad Casts Burr Cells; Keratocytes

NCI Code C74634

CDISC Submission Value Bite Cells/Erythrocytes

CDISC Definition A relative measurement (ratio or percentage) of bite cells (erythrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) to all erythrocytes in a biological specimen . A measurement of the blast cells in a biological specimen. A relative measurement (ratio or percentage) of the blasts to leukocytes in a biological specimen. A measurement of the urea nitrogen in a blood specimen. A measurement of the bone specific alkaline phosphatase isoform in a biological specimen. A measurement of the brain (B-type) natriuretic peptide in a biological specimen.

NCI Preferred Term Bite Cell to Erythrocyte Ratio Measurement

C74605 C64487 C61019 C92287

Blasts Blasts/Leukocytes Blood Urea Nitrogen Bone Specific Alkaline Phosphatase Brain Natriuretic Peptide

Blast Count Blast To Leukocyte Ratio Blood Urea Nitrogen Measurement Bone Specific Alkaline Phosphatase Measurement Brain Natriuretic Peptide Measurement

C74735

C82004

Brain-Derived Neurotrophic Factor Broad Casts Burr Cells

A measurement of the brain-derived neurotrophic factor in a biological specimen. A measurement of the broad casts in a biological specimen. A measurement of the Burr cells (erythrocytes characterized by the presence of small, blunt projections evenly distributed across the cell surface) in a biological specimen. A measurement of the C reactive protein in a biological specimen. A measurement of the C (connecting) peptide of insulin in a biological specimen. A measurement of the CD19 B cells in a biological specimen. A relative measurement (ratio or percentage) of CD19 B cells to all lymphocytes in a biological specimen. A measurement of the CD3 T cells in a biological specimen. A relative measurement (ratio or percentage) of CD3 T cells to all lymphocytes in a biological specimen. A measurement of the CD34 expressing cells per unit in a biological specimen. A measurement of the CD4 T cells in a biological specimen. A relative measurement (ratio or percentage) of CD4 T cells to the CD8 T cells in a biological specimen. A relative measurement (ratio or percentage) of CD4 T cells to all lymphocytes in a biological specimen.

Brain-Derived Neurotrophic Factor Measurement Broad Casts Measurement Burr Cell Count

C96588 C74701

C64548 C74736 C74606 C74635 C74607 C74636 C102260 C74608 C74637 C74638

C Reactive Protein C-peptide CD19 CD19/Lymphocytes CD3 CD3/Lymphocytes CD34 CD4 CD4/CD8 CD4/Lymphocytes

C Reactive Protein C-peptide CD19 CD19/ Lymphocytes CD3 CD3/ Lymphocytes CD34 CD4 CD4/CD8 CD4/ Lymphocytes

C-Reactive Protein Measurement C-peptide Measurement CD19 Expressing B Cell Count CD19 B Cell to Lymphocyte Ratio Measurement CD3 Expressing T Cell Count CD3 T Cell to Lymphocyte Ratio Measurement CD34 Measurement CD4 Expressing T Cell Count CD4 T Cell to CD8 T Cell Ratio Measurement CD4 T Cell to Lymphocyte Ratio Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 120 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym CD40 CD40 Ligand CD8 CD8/ Lymphocytes CMV Viral Load Cabot Rings

NCI Code C82006 C82007 C74609 C74639 C98716 C74702

CDISC Submission Value CD40 CD40 Ligand CD8 CD8/Lymphocytes CMV Viral Load Cabot Rings

CDISC Definition A measurement of the CD40 in a biological specimen. A measurement of the CD40 ligand in a biological specimen. A measurement of the CD8 T cells in a biological specimen. A relative measurement (ratio or percentage) of CD8 T cells to all lymphocytes in a biological specimen. A measurement of the cytomegalovirus viral load in a biological specimen. A measurement of the Cabot rings (red-purple staining, threadlike, ring or figure 8 shaped filaments in an erythrocyte) in a biological specimen. A measurement of the calcitonin hormone in a biological specimen. A measurement of the calcitriol hormone in a biological specimen. A measurement of the calcium in a biological specimen. A measurement of the calcium carbonate crystals present in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of calcium by excretion of urine for a specified unit of time (e.g. one minute). A measurement of the calcium oxalate crystals present in a biological specimen. A measurement of the calcium phosphate crystals present in a biological specimen. A measurement of the calcium sulphate in a biological specimen. A measurement of the ionized calcium in a biological specimen. A relative measurement (ratio or percentage) of the calcium to creatinine in a biological specimen. A measurement of the calprotectin in a biological specimen. A measurement of the cancer antigen 125 in a biological specimen. A measurement of the cancer antigen 19-9 in a biological specimen. A measurement of any cannabinoid class drug present in a biological specimen.

NCI Preferred Term CD40 Measurement CD40 Ligand Measurement CD8 Expressing T Cell Count CD8 T Cell to Lymphocyte Ratio Measurement Cytomegalovirus Viral Load Measurement Cabot Ring Count

C74848 C74849 C64488 C74669

Calcitonin Calcitriol Calcium Calcium Carbonate Crystals

Calcitonin Calcitriol Calcium Calcium Carbonate Crystals Calcium Clearance Calcium Oxalate Crystals Calcium Phosphate Crystals Calcium Sulphate Calcium, Ionized Calcium/ Creatinine Calprotectin Cancer Antigen 125 Cancer Antigen 19-9 Cannabinoids

Calcitonin Measurement Calcitriol Measurement Calcium Measurement Calcium Carbonate Crystal Measurement Calcium Clearance Measurement

C96589

Calcium Clearance

C74670 C74671

Calcium Oxalate Crystals Calcium Phosphate Crystals

Calcium Oxalate Crystal Measurement Calcium Phosphate Crystal Measurement Calcium Sulphate Measurement Ionized Calcium Measurement Calcium to Creatinine Ratio Measurement Calprotectin Measurement Cancer Antigen 125 Measurement Cancer Antigen 19-9 Measurement Cannabinoid Drug Class Measurement

C96590 C81948 C79439 C82005 C81981 C81982 C74689

Calcium Sulphate Calcium, Ionized Calcium/Creatinine Calprotectin Cancer Antigen 125 Cancer Antigen 19-9 Cannabinoids

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 121 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Carbohydrate-De ficient Transferrin Carbon Dioxide Carboxyhemoglo bin Carcinoembryoni c Antigen Carnitine Carnitine Acetyl Transferase Carnitine, Free Casts Cellular Casts

NCI Code C101016

CDISC Submission Value Carbohydrate-Deficient Transferrin Carbon Dioxide Carboxyhemoglobin Carcinoembryonic Antigen Carnitine Carnitine Acetyl Transferase Carnitine, Free Casts Cellular Casts

CDISC Definition A measurement of transferrin with a reduced number of carbohydrate moieties in a biological specimen. A measurement of the carbon dioxide gas in a biological specimen. A measurement of the carboxyhemoglobin in a biological specimen. A measurement of the carcinoembryonic antigen in a biological specimen. A measurement of the total carnitine in a biological specimen. A measurement of the carnitine acetyl transferase in a biological specimen. A measurement of the free carnitine in a biological specimen. A statement that indicates casts were looked for in a biological specimen. A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a biological specimen. A measurement of ceruloplasmin in a biological specimen. A measurement of the CXCR3, chemokine (C-X-C motif) receptor 3, in a biological specimen.

NCI Preferred Term Carbohydrate-Deficient Transferrin Measurement Carbon Dioxide Measurement Carboxyhemoglobin Measurement Carcinoembryonic Antigen Measurement Total Carnitine Measurement Carnitine Acetyl Transferase Measurement Free Carnitine Measurement Cast Present Or Absent Cellular Cast Measurement

C64545 C96591 C81983 C74682 C92288 C74677 C74763 C74764

C100432 C100431

Ceruloplasmin Chemokine (C-X-C Motif) Receptor 3

Ceruloplasmin; Caeruloplasmin Chemokine (C-X-C Motif) Receptor 3; GPR9, CD183, CXCR3 Chlamydia pneumoniae IgA Antibody Chlamydia pneumoniae IgM Antibody Chlamydia trachomatis IgA Antibody Chlamydia trachomatis IgG Antibody Chlamydia trachomatis IgM Antibody Chloride Chloride/ Creatinine

Ceruloplasmin Measurement Chemokine Receptor CXCR3 Measurement

C92432

Chlamydia pneumoniae IgA Antibody Chlamydia pneumoniae IgM Antibody Chlamydia trachomatis IgA Antibody Chlamydia trachomatis IgG Antibody Chlamydia trachomatis IgM Antibody Chloride Chloride/Creatinine

A measurement of the Chlamydia pneumoniae IgA antibody in a biological specimen. A measurement of the Chlamydia pneumoniae IgM in a biological specimen. A measurement of the Chlamydia trachomatis IgA antibody in a biological specimen. A measurement of the Chlamydia trachomatis IgG antibody in a biological specimen. A measurement of the Chlamydia trachomatis IgM antibody in a biological specimen. A measurement of the chloride in a biological specimen. A relative measurement (ratio or percentage) of the chloride to creatinine in a biological specimen.

Chlamydia pneumoniae IgA Antibody Measurement Chlamydia pneumoniae IgM Antibody Measurement Chlamydia trachomatis IgA Antibody Measurement Chlamydia trachomatis IgG Antibody Measurement Chlamydia trachomatis IgM Antibody Measurement Chloride Measurement Chloride to Creatinine Ratio Measurement

C92433

C100464

C100466

C100465

C64495 C79440

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 122 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Cholecystokinin; Pancreozymin Cholesterol; Total Cholesterol Cholesterol Crystals Cholesterol/ HDL-Cholestero l Cholinesterase Choriogonadotro pin Beta; Pregnancy Test Circulating Endothelial Cells Circulating Tumor Cells Citrate Clarity Clue Cells Cocaine Codeine Color Complement Bb Complement C1q Antibody Complement C3 Complement C3a; ASP, Complement C3 DesArg, Acetylation-stim ulating Protein Complement C3b Complement C4

NCI Code C74850 C61032

CDISC Submission Value Cholecystokinin Cholesterol

CDISC Definition A measurement of the cholecystokinin hormone in a biological specimen. A measurement of the cholesterol in a biological specimen. A measurement of the cholesterol crystals present in a biological specimen. A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a biological specimen. A measurement of the cholinesterase in a biological specimen. A measurement of the Choriogonadotropin Beta in a biological specimen. A measurement of the circulating endothelial cells in a biological specimen. A measurement of the circulating tumor cells in a biological specimen. A measurement of the citrate in a biological specimen. A measurement of the transparency of a biological specimen. A measurement of the clue cells in a biological specimen. A measurement of the cocaine present in a biological specimen. A measurement of the codeine present in a biological specimen. A measurement of the color of a biological specimen. A measurement of the complement Bb in a biological specimen. A measurement of the complement C1q antibody in a biological specimen. A measurement of the complement C3 in a biological specimen. A measurement of the complement C3a in a biological specimen.

NCI Preferred Term Cholecystokinin Measurement Serum Total Cholesterol Measurement Cholesterol Crystal Measurement Cholesterol to HDL-Cholesterol Ratio Measurement Cholinesterase Measurement Choriogonadotropin Beta Measurement Circulating Endothelial Cell Count Circulating Tumor Cell Count Citrate Measurement Clarity Measurement Clue Cell Count Cocaine Measurement Codeine Measurement Color Assessment Complement Bb Measurement Complement C1q Antibody Measurement Complement C3 Measurement Complement C3a Measurement

C74672 C80171

Cholesterol Crystals Cholesterol/HDL-Cholesterol

C92289 C64851

Cholinesterase Choriogonadotropin Beta

C96592 C96593 C92248 C96594 C102261 C74690 C74877 C64546 C80172 C80173 C80174 C80175

Circulating Endothelial Cells Circulating Tumor Cells Citrate Clarity Clue Cells Cocaine Codeine Color Complement Bb Complement C1q Antibody Complement C3 Complement C3a

C80176 C80177

Complement C3b Complement C4

A measurement of the complement C3b in a biological specimen. A measurement of the complement C4 in a biological specimen.

Complement C3b Measurement Complement C4 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 123 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Complement C4a Complement C5a Complement CH50; Total Hemolytic Complement; CH50 Complement Total Corticosterone Corticotropin Releasing Hormone; Corticotropin Releasing Factor Cortisol; Total Cortisol Cortisol, Free Cotinine Creatine Kinase Creatine Kinase BB Creatine Kinase BB/Total Creatine Kinase Creatine Kinase MB Creatine Kinase MB/Total Creatine Kinase Creatine Kinase MM Creatine Kinase MM/Total Creatine Kinase Creatinine Creatinine Clearance

NCI Code C80178 C80179 C100423

CDISC Submission Value Complement C4a Complement C5a Complement CH50

CDISC Definition A measurement of the complement C4a in a biological specimen. A measurement of the complement C5a in a biological specimen. A measurement of the complement required to lyse 50 percent of red blood cells in a biological specimen.

NCI Preferred Term Complement C4a Measurement Complement C5a Measurement CH50 Measurement

C80160 C79434 C74851

Complement Total Corticosterone Corticotropin Releasing Hormone

A measurement of the total complement in a biological specimen. A measurement of corticosterone in a biological specimen. A measurement of the corticotropin releasing hormone in a biological specimen.

Complement Measurement Corticosterone Measurement Corticotropin Releasing Hormone Measurement

C74781 C88113 C92249 C64489 C64490 C79466

Cortisol Cortisol, Free Cotinine Creatine Kinase Creatine Kinase BB Creatine Kinase BB/Total Creatine Kinase Creatine Kinase MB Creatine Kinase MB/Total Creatine Kinase Creatine Kinase MM Creatine Kinase MM/Total Creatine Kinase Creatinine Creatinine Clearance

A measurement of the cortisol in a biological specimen. A measurement of the free, unbound cortisol in a biological specimen. A measurement of the cotinine in a biological specimen. A measurement of the total creatine kinase in a biological specimen. A measurement of the homozygous B-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the BB-type creatine kinase to total creatine kinase in a biological specimen. A measurement of the heterozygous MB-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the MB-type creatine kinase to total creatine kinase in a biological specimen. A measurement of the homozygous M-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the MM-type creatine kinase to total creatine kinase in a biological specimen. A measurement of the creatinine in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of creatinine by excretion of urine for a specified unit of time (e.g. one minute).

Cortisol Measurement Free Cortisol Measurement Cotinine Measurement Creatine Kinase Measurement Creatine Kinase BB Measurement Creatine Kinase BB to Total Creatine Kinase Ratio Measurement Creatine Kinase MB Measurement Creatine Kinase MB to Total Creatine Kinase Ratio Measurement Creatine Kinase MM Measurement Creatine Kinase MM to Total Creatine Kinase Ratio Measurement Creatinine Measurement Creatinine Clearance

C64491 C79441

C64494 C79442

C64547 C25747

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 124 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Crenated Cells; Echinocytes

NCI Code C74703

CDISC Submission Value Crenated Cells

CDISC Definition A measurement of the Burr cells (erythrocytes characterized by the presence of multiple small, sharp projections evenly distributed across the cell surface) in a biological specimen. A statement that indicates crystals were looked for in a biological specimen. A measurement of the cyclic citrullinated peptide antibody in a biological specimen. A measurement of the cystatin C in a biological specimen. A measurement of the cystine crystals present in a biological specimen. A measurement of the cytomegalovirus IgG antibody in a biological specimen. A measurement of the cytomegalovirus IgM antibody in a biological specimen. A measurement of the d-dimers in a biological specimen. A measurement of Dnase-B antibody in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of Diethylenetriamine pentaacetate (DTPA) through its excretion for a specified unit of time. A measurement of dacryocytes in a biological specimen.

NCI Preferred Term Crenated Cell Measurement

C74673 C96595

Crystals Cyclic Citrullinated Peptide Antibody Cystatin C Cystine Crystals Cytomegalovirus IgG Antibody Cytomegalovirus IgM Antibody D-Dimer DNase-B Antibody

Crystals Cyclic Citrullinated Peptide Antibody Cystatin C Cystine Crystals Cytomegalovirus IgG Antibody Cytomegalovirus IgM Antibody D-Dimer DNase-B Antibody; Anti-Dnase B DTPA Clearance

Crystal Present Or Absent Cyclic Citrullinated Peptide Antibody Measurement Cystatin C Measurement Cystine Crystal Measurement Cytomegalovirus IgG Antibody Measurement Cytomegalovirus IgM Antibody Measurement D-Dimer Measurement DNase-B Antibody Measurement

C92290 C74674 C96596 C96597 C82621 C100463

C100441

DTPA Clearance

Diethylene Triamine Pentaacetic Acid Clearance

C64801

Dacryocytes

Dacryocytes; Tear Shaped Erythrocytes; Teardrop Cells Dehydroepiandro sterone; Dehydroisoandro sterone Dehydroepiandro sterone Sulfate; DHEA-S; sDHEA; DHEA Sulfate Deoxypyridinoli ne Deoxypyridinoli ne/Creatinine Dextroamphetam ine; d-amphetamine

Dacryocyte Analysis

C74852

Dehydroepiandrosterone

A measurement of the dehydroepiandrosterone hormone in a biological specimen.

Dehydroepiandrosterone Measurement

C96629

Dehydroepiandrosterone Sulfate

A measurement of the sulfated Dehydroepiandrosterone in a biological specimen.

Sulfated DHEA Measurement

C79443 C79444

Deoxypyridinoline Deoxypyridinoline/Creatinine

A measurement of the deoxypyridinoline in a biological specimen. A relative measurement (ratio or percentage) of the deoxypyridinoline to creatinine in a biological specimen. A measurement of the dextroamphetamine in a biological specimen.

Deoxypyridinoline Measurement Deoxypyridinoline to Creatinine Ratio Measurement Dextroamphetamine Measurement

C102262

Dextroamphetamine

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 125 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Dihydrocodeine Dihydrotestoster one; Androstanalone Dilute Russell's Viper Venom Time Direct Bilirubin Dohle Bodies

NCI Code C74878 C74853

CDISC Submission Value Dihydrocodeine Dihydrotestosterone

CDISC Definition A measurement of the dihydrocodeine present in a biological specimen. A measurement of the dihydrotestosterone hormone in a biological specimen. A measurement of the time it takes a plasma sample to clot after adding dilute Russell's viper venom. A measurement of the conjugated or water-soluble bilirubin in a biological specimen. A measurement of the Dohle bodies (blue-gray, basophilic, leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. A measurement of the dopamine hormone in a biological specimen. An indication of the presence or absence of recreational drugs or drugs of abuse in a biological specimen. A measurement of the Epstein-Barr virus viral load in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of Ethylenediamine tetraacetic acid (EDTA) through its excretion for a specified unit of time. A measurement of the area under the thrombin generation curve.

NCI Preferred Term Dihydrocodeine Measurement Dihydrotestosterone Measurement

C96696

Dilute Russell's Viper Venom Time Direct Bilirubin Dohle Bodies

Dilute Russell's Viper Venom Time Measurement Direct Bilirubin Measurement Dohle Body Measurement

C64481 C74610

C74854 C78139

Dopamine Drug Screen

Dopamine Drug Screen

Dopamine Measurement Drug Test

C98721 C100440

EBV Viral Load EDTA Clearance

EBV Viral Load EDTA Clearance

Epstein-Barr Virus Viral Load Measurement EDTA Clearance

C102263

ETP Area Under Curve

ETP Area Under Curve; Endogenous Thrombin Potential Area Under Curve ETP Lag Time; Endogenous Thrombin Potential Lag Time ETP Lag Time Relative; Endogenous Thrombin Potential Lag Time Relative ETP Peak Height; Endogenous Thrombin Potential Peak Height

Endogenous Thrombin Potential Area Under Curve Measurement

C102264

ETP Lag Time

A measurement of time from the start of the thrombin generation test to the point where a predetermined amount of thrombin is generated.

Endogenous Thrombin Potential Lag Time Measurement

C102265

ETP Lag Time Relative

A relative measurement (ratio or percentage) of time from the start of the thrombin generation test to the point where a predetermined amount of thrombin is generated.

Endogenous Thrombin Potential Lag Time Relative Measurement

C102267

ETP Peak Height

A measurement of the maximum concentration of thrombin generated during a thrombin generation test.

Endogenous Thrombin Potential Peak Height Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 126 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym ETP Peak Height Relative; Endogenous Thrombin Potential Peak Height Relative ETP Time to Peak; Endogenous Thrombin Potential Time to Peak ETP Time to Peak Relative; Endogenous Thrombin Potential Time to Peak Relative Ecarin Clotting Time Eccentrocytes

NCI Code C102268

CDISC Submission Value ETP Peak Height Relative

CDISC Definition A relative (ratio or percentage) of the maximum concentration of thrombin generated during a thrombin generation test.

NCI Preferred Term Endogenous Thrombin Potential Peak Height Relative Measurement

C102269

ETP Time to Peak

A measurement of the time it takes to generate the maximum concentration of thrombin.

Endogenous Thrombin Potential Time to Peak Measurement

C102270

ETP Time to Peak Relative

A relative (ratio or percentage) measurement of the time it takes to generate the maximum concentration of thrombin.

Endogenous Thrombin Potential Time to Peak Relative Measurement

C100422

Ecarin Clotting Time

A measurement of the activity of thrombin inhibitors in a biological specimen based on the generation of meizothrombin. A measurement of the eccentrocytes (erythrocytes in which the hemoglobin is localized to a particular portion of the cell, noticeable as localized staining) in a biological specimen. A measurement of the elliptically shaped erythrocytes in a biological specimen. A measurement of the total concentration of thrombin generated in the presence of a substrate in a plasma or blood sample. A measurement of the endothelin-1 in a biological specimen. A measurement of the eosinphilic metamyelocytes in a biological specimen. A measurement of the eosinophilic myelocytes in a biological specimen. A measurement of the eosinophils in a biological specimen. A relative measurement (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the eosinophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the eotaxin-1 in a biological specimen. A measurement of the eotaxin-2 in a biological specimen.

Ecarin Clotting Time Measurement

C96598

Eccentrocytes

Eccentrocyte Count

C64549 C102266

Elliptocytes Endogenous Thrombin Potential Endothelin-1 Eosinophilic Metamyelocytes Eosinophilic Myelocytes Eosinophils Eosinophils/Leukocytes Eosinophils/Total Cells

Elliptocytes; Ovalocytes Endogenous Thrombin Potential Endothelin-1 Eosinophilic Metamyelocytes Eosinophilic Myelocytes Eosinophils Eosinophils/ Leukocytes Eosinophils/ Total Cells Eotaxin-1; Chemokine Ligand 11 Eotaxin-2; Chemokine Ligand 24

Elliptocyte Count Endogenous Thrombin Potential Measurement Endothelin-1 Measurement Eosinophilic Metamyelocyte Count Eosinophilic Myelocyte Count Eosinophil Count Eosinophil To Leukocyte Ratio Eosinophils to Total Cell Ratio Measurement Eotaxin-1 Measurement

C82008 C84819 C84821 C64550 C64604 C98720

C81952

Eotaxin-1

C81953

Eotaxin-2

Eotaxin-2 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 127 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Eotaxin-3; Chemokine Ligand 26 Epidermal Growth Factor Epinephrine; Adrenaline Epith Neutrophil-Activ ating Peptide 78 Epithelial Casts Epithelial Cells Epstein-Barr Capsid IgG Antibody Epstein-Barr Capsid IgM Antibody Epstein-Barr Early Antigen Epstein-Barr Nuclear Antibody Epstein-Barr Nuclear Antigen Ery. Mean Corpuscular HGB Concentration Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular Volume Erythrocyte Cell Clumps; Red Blood Cell Clumps; RBC Clumps Erythrocyte Cell Morphology; Red Blood Cell Morphology; RBC Morphology

NCI Code C81954

CDISC Submission Value Eotaxin-3

CDISC Definition A measurement of the eotaxin-3 in a biological specimen. A measurement of the epidermal growth factor in a biological specimen. A measurement of the epinephrine hormone in a biological specimen. A measurement of the epithelial neutrophil-activating peptide in a biological specimen. A measurement of the epithelial cell casts present in a biological specimen. A measurement of the epithelial cells in a biological specimen. A measurement of the Epstein-Barr capsid IgG antibody in a biological specimen. A measurement of the Epstein-Barr capsid IgM antibody in a biological specimen. A measurement of the Epstein-Barr early antigen in a biological specimen. A measurement of the Epstein-Barr nuclear antibody in a biological specimen. A measurement of the Epstein-Barr nuclear antigen in a biological specimen. A quantitative measurement of the mean amount of hemoglobin per erythrocytes in a specified volume of a biological specimen. A quantitative measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen. A quantitative measurement of the mean volume of erythrocytes in a biological specimen. A measurement of red blood cell clumps in a biological specimen.

NCI Preferred Term Eotaxin-3 Measurement

C82009 C79445 C82010

Epidermal Growth Factor Epinephrine Epith Neutrophil-Activating Peptide 78 Epithelial Casts Epithelial Cells Epstein-Barr Capsid IgG Antibody Epstein-Barr Capsid IgM Antibody Epstein-Barr Early Antigen Epstein-Barr Nuclear Antibody Epstein-Barr Nuclear Antigen Ery. Mean Corpuscular HGB Concentration

Epidermal Growth Factor Measurement Epinephrine Measurement Epithelial Neutrophil-Activating Peptide 78 Measurement Epithelial-Cast Measurement Epithelial Cell Count Epstein-Barr Capsid IgG Antibody Measurement Epstein-Barr Capsid IgM Antibody Measurement Epstein-Barr Early Antigen Measurement Epstein-Barr Nuclear Antibody Measurement Epstein-Barr Nuclear Antigen Measurement Erythrocyte Mean Corpuscular Hemoglobin Concentration

C74779 C64605 C96600

C96601

C96602 C96603

C96604 C64798

C64797

Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular Volume Erythrocyte Cell Clumps

Erythrocyte Mean Corpuscular Hemoglobin Erythrocyte Mean Corpuscular Volume Erythrocyte Cell Clumps Measurement

C64799

C92245

C92296

Erythrocyte Cell Morphology

An examination or assessment of the form and structure of red blood cells.

Erythrocyte Cell Morphology

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 128 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Erythrocyte Ghosts; RBC Ghosts Erythrocyte Sedimentation Rate; Biernacki Reaction Erythrocytes; Red Blood Cells Erythrocytes Distribution Width Erythropoietin; Hematopoietin Estradiol; Oestradiol Estriol; Oestriol Estriol, Free Estrone; Oestrone Ethanol; Alcohol

NCI Code C96605

CDISC Submission Value Erythrocyte Ghosts

CDISC Definition A measurement of the erythrocyte ghosts (erythrocytes in which hemoglobin has been removed through hemolysis) in a biological specimen. The distance (e.g. millimeters) that red blood cells settle in unclotted blood over a specified unit of time (e.g. one hour). A measurement of the total erythrocytes in a biological specimen. A value derived from mean corpuscular volume and the standard deviation of the red blood cell volume in a whole blood specimen. A measurement of the erythropoietin hormone in a biological specimen. A measurement of the estradiol in a biological specimen. A measurement of the estriol hormone in a biological specimen. A measurement of the free estriol in a biological specimen. A measurement of the estrone hormone in a biological specimen. A measurement of the ethanol present in a biological specimen.

NCI Preferred Term Erythrocyte Ghost Count

C74611

Erythrocyte Sedimentation Rate

Erythrocyte Sedimentation Rate Measurement

C51946 C64800

Erythrocytes Erythrocytes Distribution Width Erythropoietin Estradiol Estriol Estriol, Free Estrone Ethanol Extracell Newly Ident RAGE Bind Protein

Erythrocyte Count Erythrocyte Distribution Width Measurement Erythropoietin Measurement Estradiol Measurement Estriol Measurement Free Estriol Measurement Estrone Measurement Ethanol Measurement Extracell Newly Ident RAGE Bind Protein Measurement

C74855 C74782 C74856 C81963 C74857 C74693 C82011

Extracell Newly A measurement of the extracellular newly identified Ident RAGE Bind RAGE (receptor for advanced glycation end products) Protein; S100 binding protein in a biological specimen. Calcium Binding Protein A12 Anti-ENA; Extractable Nuclear Antigen Antibody F2-Isoprostane Factor II; Prothrombin Factor III; Tissue Factor, CD142 Factor IX Factor V Factor V Leiden Factor VII A measurement of the extractable nuclear antigen antibody in a biological specimen.

C92270

Extractable Nuclear Antigen Antibody

Extractable Nuclear Antigen Antibody Measurement

C80180 C96626 C81959 C98725 C98726 C102271 C81960

F2-Isoprostane Factor II Factor III Factor IX Factor V Factor V Leiden Factor VII

A measurement of the F2-isoprostane in a biological specimen. A measurement of the Factor II in a biological specimen. A measurement of the factor III in a biological specimen. A measurement of the factor IX in a biological specimen. A measurement of the factor V in a biological specimen. A measurement of the Factor V Leiden in a biological specimen. A measurement of the factor VII in a biological specimen.

F2 Isoprostane Measurement Prothrombin Measurement Factor III Measurement Factor IX Measurement Factor V Measurement Factor V Leiden Measurement Factor VII Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 129 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Factor VIII Factor X Factor XIV; Autoprothrombin IIA; Protein C Fat Fat Bodies, Oval

NCI Code C81961 C98727 C102272

CDISC Submission Value Factor VIII Factor X Factor XIV

CDISC Definition A measurement of the factor VIII in a biological specimen. A measurement of the factor X in a biological specimen. A measurement of the factor XIV in a biological specimen. A measurement of the fat in a biological specimen. A measurement of the oval-shaped fat bodies, usually renal proximal tubular cells with lipid aggregates in the cytoplasm, in a biological specimen. A measurement of the triglyceride aggregates within a biological specimen. A measurement of the fatty acid binding protein 1 in a biological specimen. A measurement of the fatty casts present in a biological specimen. A measurement of the ferritin in a biological specimen. A measurement of the fibrin degradation products in a biological specimen. A measurement of the fibrinogen in a biological specimen. A measurement of the fibroblast growth factor 23 in a biological specimen. A measurement of the basic form of fibroblast growth factor in a biological specimen.

NCI Preferred Term Factor VIII Measurement Factor X Measurement Factor XIV Measurement

C96648 C81947

Fat Fat Bodies, Oval

Fat Measurement Oval Fat Body Measurement

C98728 C82012

Fat Droplet Fatty Acid Binding Protein 1

Fat Droplet Fatty Acid Binding Protein 1 Fatty Casts Ferritin Fibrin Degradation Products Fibrinogen Fibroblast Growth Factor 23; Phosphatonin Fibroblast Growth Factor Basic Form; FGF2 Follicle Stimulating Hormone Free Fatty Acid; Non-Esterified Fatty Acid, Free Free Fatty Acid, Saturated; Non-esterified Fatty Acid, Saturated Free Fatty Acid, Unsaturated; Non-esterified Fatty Acid, Unsaturated

Fat Droplet Measurement Fatty Acid Binding Protein 1 Measurement Fatty Cast Measurement Ferritin Measurement Fibrin Degradation Products Measurement Fibrinogen Measurement Fibroblast Growth Factor 23 Measurement Fibroblast Growth Factor Basic Form Measurement

C74766 C74737 C82013

Fatty Casts Ferritin Fibrin Degradation Products

C64606 C96650

Fibrinogen Fibroblast Growth Factor 23

C82014

Fibroblast Growth Factor Basic Form

C74783

Follicle Stimulating Hormone

A measurement of the follicle stimulating hormone (FSH) in a biological specimen. A measurement of the total non-esterified fatty acids in a biological specimen. A measurement of the saturated non-esterified fatty acids in a biological specimen.

Follicle Stimulating Hormone Measurement Non-esterified Fatty Acids Measurement Saturated Non-esterified Fatty Acids Measurement

C80200

Free Fatty Acid

C80206

Free Fatty Acid, Saturated

C80209

Free Fatty Acid, Unsaturated

A measurement of the unsaturated non-esterified fatty acids in a biological specimen.

Unsaturated Non-esterified Fatty Acids Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 130 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Free Glycerol; Free Glycerin Fructosamine; Glycated Serum Protein GFR from B-2 Microglobulin Adj for BSA GFR from Beta-Trace Protein Adj for BSA GFR from Creatinine Adjusted for BSA GFR from Cystatin C Adjusted for BSA Galanin Gamma Globulin Gamma Globulin/Total Protein

NCI Code C100448 C74678

CDISC Submission Value Free Glycerol Fructosamine

CDISC Definition A measurement of the amount of unbound glycerol in a biological specimen. A measurement of the fructosamine in a biological specimen. A measurement of the glomerular filtration rate (GFR) based on the clearance of beta-2 microglobulin after adjusting it for the body surface area. A measurement of the glomerular filtration rate (GFR) based on the clearance of beta-trace protein after adjusting it for the body surface area. An estimation of the glomerular filtration rate adjusted for body size based on creatinine.

NCI Preferred Term Free Glycerol Measurement Fructosamine Measurement

C100450

GFR from B-2 Microglobulin Adj for BSA GFR from Beta-Trace Protein Adj for BSA

Glomerular Filtration Rate from B-2 Microglobulin Adjusted for BSA Measurement Glomerular Filtration Rate from Beta-Trace Protein Adjusted for BSA Measurement Glomerular Filtration Rate from Creatinine Adjusted for BSA

C100449

C98735

GFR from Creatinine Adjusted for BSA

C98736

GFR from Cystatin C Adjusted for BSA

An estimation of the glomerular filtration rate adjusted for body size based on cystatin C.

Glomerular Filtration Rate from Cystatin C Adjusted for BSA

C80182 C92257 C92295

Galanin Gamma Globulin Gamma Globulin/Total Protein Gamma Glutamyl Transferase Gamma Glutamyl Transferase/Creatinine Gastrin Giant Neutrophils Giant Platelets Globulin Glomerular Filtration Rate

A measurement of the galanin in a biological specimen. A measurement of the proteins contributing to the gamma fraction in a biological specimen. A relative measurement (ratio or percentage) of gamma fraction proteins to total proteins in a biological specimen.

Galanin Measurement Gamma Globulin Measurement Gamma Globulin to Total Protein Ratio Measurement Gamma Glutamyl Transpeptidase Measurement Gamma Glutamyl Transferase to Creatinine Ratio Measurement Gastrin Measurement Giant Neutrophil Count Giant Platelet Count Globulin Protein Measurement Glomerular Filtration Rate

C64847 C79446

Gamma Glutamyl A measurement of the gamma glutamyl transferase in a Transferase biological specimen. Gamma Glutamyl A relative measurement (ratio or percentage) of the Transferase/ gamma glutamyl transferase to creatinine in a Creatinine biological specimen. Gastrin Giant Neutrophils Giant Platelets Globulin Glomerular Filtration Rate Glomerular Filtration Rate Adj for BSA Glucagon A measurement of the gastrin hormone in a biological specimen. A measurement of the giant neutrophils in a biological specimen. A measurement of the giant (larger than 7um in diameter) platelets in a biological specimen. A measurement of the globulin protein in a biological specimen. A kidney function test that measures the fluid volume that is filtered from the kidney glomeruli to the Bowman's capsule per unit of time. A measurement of the glomerular filtration rate adjusted for body size. A measurement of the glucagon hormone in a biological specimen.

C74858 C96651 C74728 C74738 C90505

C98734

Glomerular Filtration Rate Adj for BSA Glucagon

Glomerular Filtration Rate Adjusted for BSA Glucagon Measurement

C74859

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 131 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Glucagon-Like Peptide-1; Total Glucagon-Like Peptide-1 Glucagon-Like Peptide-1, Active Form Glucose Glucose Clearance Glucose-6-Phos phate Dehydrogenase Glucose/ Creatinine Glucuronidase, Alpha Glucuronidase, Beta Glutamate; Glutamic Acid Glutamate Dehydrogenase Glutamic Acid Decarboxylase 1; Glutamic Acid Decarboxylase 67 Glutamic Acid Decarboxylase 2; Glutamic Acid Decarboxylase 65 Glutamic Acid Decarboxylase 2 Antibody; Glutamic Acid Decarboxylase 65 Antibody Glutamic Acid Decarboxylase Antibody; GAD Antibody Glutathione S-Transferase, Alpha/Creat Glutathione S-Transferase, Pi

NCI Code C80183

CDISC Submission Value Glucagon-Like Peptide-1

CDISC Definition A measurement of the total glucagon-like peptide-1 in a biological specimen.

NCI Preferred Term Glucagon-like Peptide-1 Measurement

C80164

Glucagon-Like Peptide-1, Active Form Glucose Glucose Clearance Glucose-6-Phosphate Dehydrogenase Glucose/Creatinine Glucuronidase, Alpha Glucuronidase, Beta Glutamate Glutamate Dehydrogenase Glutamic Acid Decarboxylase 1

A measurement of the active form of glucagon-like peptide-1 in a biological specimen. A measurement of the glucose in a biological specimen. A measurement of the glucose clearance in a biological specimen. A measurement of the glucose-6-phosphate dehydrogenase in a biological specimen. A relative measurement (ratio or percentage) of the glucose to creatinine in a biological specimen. A measurement of the alpha glucuronidase in a biological specimen. A measurement of the beta glucuronidase in a biological specimen. A measurement of the glutamate in a biological specimen. A measurement of the glutamate dehydrogenase in a biological specimen. A measurement of the glutamic acid decarboxylase 1 in a biological specimen.

Active Glucagon-like Peptide-1 Measurement Plasma Glucose Measurement Glucose Clearance Measurement Glucose-6-Phosphate Dehydrogenase Measurement Glucose to Creatinine Ratio Measurement Alpha Glucuronidase Measurement Beta Glucuronidase Measurement Glutamate Measurement Glutamate Dehydrogenase Measurement Glutamic Acid Decarboxylase 1 Measurement

C41376 C96652 C80184

C79447 C80165 C80170 C74739 C79448 C82015

C82016

Glutamic Acid Decarboxylase 2

A measurement of the glutamic acid decarboxylase 2 in a biological specimen.

Glutamic Acid Decarboxylase 2 Measurement

C82017

Glutamic Acid Decarboxylase 2 Antibody

A measurement of the glutamic acid decarboxylase 2 antibody in a biological specimen.

Glutamic Acid Decarboxylase 2 Antibody Measurement

C96653

Glutamic Acid Decarboxylase Antibody

A measurement of the glutamic acid decarboxylase antibody in a biological specimen.

Glutamic Acid Decarboxylase Antibody Measurement

C80166

Glutathione S-Transferase, Alpha/Creat Glutathione S-Transferase, Pi

A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a biological specimen. A measurement of the Pi glutathione-s-transferase in a biological specimen.

Alpha Glutathione-S-Transferase to Creatinine Ratio Measurement Pi Glutathione S-Transferase Measurement

C80203

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 132 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Glutathione S-Transferase, Theta Glutathione S-Transferase, Total Glutathione-S-Tr ansferase/ Creatinine Gold Gonadotropin Releasing Hormone; Luteinising Hormone Releasing Hormone Granular Casts Granular Coarse Casts Granular Fine Casts Granulocyte Colony Stimulating Factor Granulocyte Macrophage Colony Stm Factor Granulocytes Granulocytes/ Total Cells Growth Hormone Inhibiting Hormone; Somatostatin Growth Hormone Releasing Hormone; Somatocrinin HAV Viral Load

NCI Code C80207

CDISC Submission Value Glutathione S-Transferase, Theta Glutathione S-Transferase, Total Glutathione-S-Transferase/ Creatinine Gold Gonadotropin Releasing Hormone

CDISC Definition A measurement of the theta glutathione-s-transferase in a biological specimen. A measurement of the total glutathione-s-transferase in a biological specimen. A relative measurement (ratio or percentage) of the glutathione S-transferase to creatinine in a biological specimen. A measurement of the gold in a biological specimen. A measurement of the gonadotropin releasing hormone in a biological specimen.

NCI Preferred Term Theta Glutathione S-Transferase Measurement Glutathione-S-Transferase Measurement Glutathione-S-Transferase to Creatinine Ratio Measurement Gold Measurement Gonadotropin Releasing Hormone Measurement

C80185

C79435

C80186 C74860

C74768 C74765 C74769 C82018

Granular Casts Granular Coarse Casts Granular Fine Casts Granulocyte Colony Stimulating Factor

A measurement of the granular (coarse and fine) casts present in a biological specimen. A measurement of the coarse granular casts present in a biological specimen. A measurement of the fine granular casts present in a biological specimen. A measurement of the granulocyte colony stimulating factor in a biological specimen.

Granular Cast Measurement Coarse Granular Cast Measurement Granular Fine Cast Measurement Granulocyte Colony Stimulating Factor Measurement

C82019

Granulocyte Macrophage Colony Stm Factor

A measurement of the granulocyte macrophage colony stimulating factor in a biological specimen.

Granulocyte Macrophage Colony Stm Factor Measurement

C96654 C98866

Granulocytes Granulocytes/Total Cells

A measurement of the granulocytes in a biological specimen. A relative measurement (ratio or percentage) of the granulocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the growth hormone inhibiting hormone in a biological specimen.

Granulocyte Count Granulocyte to Total CellRatio Measurement Growth Hormone Inhibiting Hormone Measurement

C74861

Growth Hormone Inhibiting Hormone

C74862

Growth Hormone Releasing Hormone

A measurement of the growth hormone releasing hormone in a biological specimen.

Growth Hormone Releasing Hormone Measurement

C92541

HAV Viral Load

A measurement of the hepatitis A viral load in a biological specimen.

Hepatitis A Viral Load Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 133 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym HBV Viral Load HCT Corrected Reticulocytes/ Erythrocytes HCV Viral Load HDL Cholesterol HDL Cholesterol/LDL Cholesterol Ratio HDL-Cholestero l Subclass 2 HDL-Cholestero l Subclass 3 HIV Viral Load HIV-1 Antibody HIV-1 Group M and O Nucleic Acid HIV-1 Group O Antibody HIV-1 p24 Antigen HIV-1/2 Antibody HIV-2 Antibody HIV-2 Nucleic Acid HLA-B27 Antigen; Human Leukocyte Antigen B27 Hairy Cells

NCI Code C92542 C102274

CDISC Submission Value HBV Viral Load HCT Corrected Reticulocytes/Erythrocytes HCV Viral Load HDL Cholesterol HDL Cholesterol/LDL Cholesterol Ratio

CDISC Definition A measurement of the hepatitis B viral load in a biological specimen. A relative measurement (ratio or percentage) of the hematocrit corrected reticulocytes to erythrocytes in a biological specimen. A measurement of the hepatitis C viral load in a biological specimen. A measurement of the high density lipoprotein cholesterol in a biological specimen. A relative measurement (ratio or percentage) of the amount of HDL cholesterol compared to LDL cholesterol in a biological specimen. A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a biological specimen. A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a biological specimen. A measurement of the HIV viral load in a biological specimen. A measurement of the antibody reaction of a biological specimen to the HIV-1 virus. A measurement of the HIV-1 group M and O nucleic acids in a biological specimen. A measurement of the HIV-1 group O antibody in a biological specimen. A measurement of the HIV-1 p24 antigen in a biological specimen. A measurement of the antibody reaction of a biological specimen to the either the HIV-1 or HIV-2 virus. A measurement of the antibody reaction of a biological specimen to the HIV-2 virus. A measurement of the HIV-2 nucleic acids in a biological specimen. A measurement of the human leukocyte antigen B27 (HLA-B27) in a biological specimen.

NCI Preferred Term Hepatitis B Viral Load Measurement Hematocrit Corrected Reticulocytes to Erythrocytes Ratio Measurement Hepatitis C Viral Load Measurement Serum HDL Cholesterol Measurement HDL Cholesterol to LDL Cholesterol Ratio Measurement

C92543 C61041 C100425

C80187 C80188 C92544 C74713 C92263

HDL-Cholesterol Subclass 2 HDL-Cholesterol Subclass 3 HIV Viral Load HIV-1 Antibody HIV-1 Group M and O Nucleic Acid HIV-1 Group O Antibody HIV-1 p24 Antigen HIV-1/2 Antibody

HDL-Cholesterol Subclass 2 Measurement HDL-Cholesterol Subclass 3 Measurement HIV Viral Load Measurement HIV-1 Antibody Measurement HIV-1 Group M and O Nucleic Acid Measurement HIV-1 Group O Antibody Measurement HIV-1 p24 Antigen Measurement HIV-1 HIV-2 Antibody Measurement

C92264 C92265 C74714

C74715 C92266 C100460

HIV-2 Antibody HIV-2 Nucleic Acid HLA-B27 Antigen

HIV-2 Antibody Measurement HIV-2 Nucleic Acid Measurement HLA-B27 Antigen Measurement

C74604

Hairy Cells

A measurement of the hairy cells (b-cell lymphocytes with hairy projections from the cytoplasm) in a biological specimen. A relative measurement (ratio or percentage) of the hairy cells (b-cell lymphocytes with hairy projections from the cytoplasm) to all lymphocytes in a biological specimen .

Hairy Cell Count

C74640

Hairy Cells/Lymphocytes

Hairy Cells/ Lymphocytes

Hairy Cell to Lymphocyte Ratio Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 134 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Haptoglobin Heinz Bodies; Heinz-Erhlich Bodies Helmet Cells

NCI Code C74740 C74709

CDISC Submission Value Haptoglobin Heinz Bodies

CDISC Definition A measurement of the haptoglobin protein in a biological specimen. A measurement of the Heinz bodies (small round inclusions within the body of a red blood cell) in a biological specimen. A measurement of the Helmet cells (specialized Keratocytes with two projections on either end that are tapered and hornlike) in a biological specimen. The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes). A measurement of the hematocrit corrected reticulocytes in a biological specimen. A measurement of the hemoglobin in a biological specimen. A measurement of the hemoglobin A in a biological specimen. A measurement of the glycosylated hemoglobin in a biological specimen. A measurement of the hemoglobin A2 in a biological specimen. A measurement of the hemoglobin B in a biological specimen. A measurement of the hemoglobin C in a biological specimen. A measurement of the hemoglobin F in a biological specimen. A measurement of the hemosiderin complex in a biological specimen. A measurement of the antibody reaction of a biological specimen to the Hepatitis A virus. A measurement of hepatitis A virus antibody IgM in a biological specimen. A measurement of the hepatitis B virus core antibody in a biological specimen. A measurement of the hepatitis B virus core IgM antibody in a biological specimen. A measurement of the surface antibody reaction of a biological specimen to the Hepatitis B virus.

NCI Preferred Term Haptoglobin Protein Measurement Heinz-Ehrlich Body Measurement

C74658

Helmet Cells

Helmet Cell Count

C64796 C102273

Hematocrit Hematocrit Corrected Reticulocytes Hemoglobin Hemoglobin A Hemoglobin A1C Hemoglobin A2 Hemoglobin B Hemoglobin C Hemoglobin F

Hematocrit Hematocrit Corrected Reticulocytes Hemoglobin Hemoglobin A Hemoglobin A1C Hemoglobin A2 Hemoglobin B Hemoglobin C Hemoglobin F; Fetal Hemoglobin Hemosiderin Hepatitis A Virus Antibody Hepatitis A Virus Antibody IgM Hepatitis B Virus Core Antibody Hepatitis B Virus Core IgM Antibody Anti-HBs; HBsAb; Hepatitis B Virus Surface Antibody HBsAg; Hepatitis B Virus Surface Antigen

Hematocrit Hematocrit Corrected Reticulocyte Count Hemoglobin Measurement Hemoglobin A Measurement Glycosylated Hemoglobin Measurement Hemoglobin A2 Measurement Hemoglobin B Measurement Hemoglobin C Measurement Hemoglobin F Measurement

C64848 C92258 C64849 C92259 C92260 C92261 C92262

C96659 C92534 C92271 C96660 C96661

Hemosiderin Hepatitis A Virus Antibody Hepatitis A Virus Antibody IgM Hepatitis B Virus Core Antibody Hepatitis B Virus Core IgM Antibody Hepatitis B Virus Surface Antibody

Hemosiderin Measurement Hepatitis A Antibody Measurement Hepatitis A Virus Antibody IgM Measurement Hepatitis B Virus Core Antibody Measurement Hepatitis B Virus Core IgM Antibody Measurement Hepatitis B Surface Antibody Measurement

C74711

C64850

Hepatitis B Virus Surface Antigen

A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.

Hepatitis B Virus Surface Antigen Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 135 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Hepatitis B Virus e Antibody Hepatitis B Virus e Antigen Hepatitis C Virus Antibody Hepatitis D Virus Antibody; Hepatitis Delta Antibody Hepatitis E Virus IgM Antibody Hepatitis G RNA Herpes Simplex Virus 1 IgG Antibody; HSV-1 IgG Antibody Herpes Simplex Virus 1 IgM Antibody Herpes Simplex Virus 1/2 IgG Antibody; HSV-1/2 IgG Ab Herpes Simplex Virus 1/2 IgM Antibody; HSV-1/2 IgM Ab Herpes Simplex Virus 2 IgG Antibody; HSV-2 IgG Antibody Herpes Simplex Virus 2 IgM Antibody Heterophile Antibodies Hexokinase Hippuric Acid Crystals Histamine Homocysteine

NCI Code C96662 C96663 C92535 C96664

CDISC Submission Value Hepatitis B Virus e Antibody Hepatitis B Virus e Antigen Hepatitis C Virus Antibody Hepatitis D Virus Antibody

CDISC Definition A measurement of the hepatitis B e antibody in a biological specimen. A measurement of the hepatitis B e antigen in a biological specimen. A measurement of the antibody reaction of a biological specimen to the Hepatitis C virus. A measurement of the hepatitis D virus antibody in a biological specimen.

NCI Preferred Term Hepatitis B Virus e Antibody Measurement Hepatitis B Virus e Antigen Measurement Hepatitis C Antibody Measurement Hepatitis D Virus Antibody Measurement

C96665 C92272 C96697

Hepatitis E Virus IgM Antibody Hepatitis G RNA Herpes Simplex Virus 1 IgG Antibody

A measurement of the hepatitis E virus IgM antibody in a biological specimen. A measurement of the Hepatitis G RNA in a biological specimen. A measurement of the herpes simplex virus 1 IgG antibody in a biological specimen.

Hepatitis E Virus IgM Antibody Measurement Hepatitis G RNA Measurement Herpes Simplex Virus 1 IgG Antibody Measurement

C98738

Herpes Simplex Virus 1 IgM Antibody Herpes Simplex Virus 1/2 IgG Antibody

A measurement of the Herpes Simplex virus 1 IgM antibodies in a biological specimen. A measurement of the herpes simplex virus 1 and 2 IgG antibody in a biological specimen.

Herpes Simplex Virus 1 IgM Antibody Measurement Herpes Simplex Virus 1/2 IgG Antibody Measurement

C96698

C96666

Herpes Simplex Virus 1/2 IgM Antibody

A measurement of the herpes simplex virus 1 and 2 IgM antibody in a biological specimen.

Herpes Simplex Virus 1/2 IgM Antibody Measurement

C96667

Herpes Simplex Virus 2 IgG Antibody

A measurement of the herpes simplex virus 2 IgG antibody in a biological specimen.

Herpes Simplex Virus 2 IgG Antibody Measurement

C98739

Herpes Simplex Virus 2 IgM Antibody Heterophile Antibodies Hexokinase Hippuric Acid Crystals Histamine Homocysteine

A measurement of the Herpes Simplex virus 2 IgM antibodies in a biological specimen. A measurement of the heterophile antibodies in a biological specimen. A measurement of the hexokinase in a biological specimen. A measurement of the hippuric acid crystals present in a biological specimen. A measurement of the histamine in a biological specimen. A measurement of the homocysteine amino acid in a biological specimen.

Herpes Simplex Virus 2 IgM Antibody Measurement Heterophile Antibody Measurement Hexokinase Measurement Hippuric Acid Crystal Measurement Histamine Measurement Homocysteine Acid Measurement

C81984 C96668 C74754 C80189 C74741

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 136 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Homostat Model Assess of Insulin Rstn; Homeostatic Model Assessment of Insulin Resistance Homovanillic Acid Howell-Jolly Bodies

NCI Code C100447

CDISC Submission Value Homostat Model Assess of Insulin Rstn

CDISC Definition An assessment of beta-cell function and insulin resistance based on fasting blood glucose and insulin concentrations.

NCI Preferred Term Homeostatic Model Assessment of Insulin Resistance

C74863 C74704

Homovanillic Acid Howell-Jolly Bodies

A measurement of the homovanillic acid metabolite in a biological specimen. A measurement of the Howell-Jolly bodies (spherical, blue-black condensed DNA inclusions within the body of a red blood cell that appear under Wright-stain) in a biological specimen. A measurement of the human anti-sheep IgE antibodies in a biological specimen. A measurement of the human anti-sheep IgG antibodies in a biological specimen. A measurement of the human anti-sheep IgM antibodies in a biological specimen. A measurement of the hyaline casts present in a biological specimen. A measurement of the hydrocodone present in a biological specimen. A measurement of the hydrogen in a biological specimen. A measurement of the hydromorphone present in a biological specimen. A measurement of the total hydroxyproline in a biological specimen. A measurement of the prevalence of the erthrocytes with an elevated hemoglobin concentration. A measurement of the hypersegmented (more than five lobes) neutrophils in a biological specimen. An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level. A measurement of the immature basophils in a biological specimen. A relative measurement (ratio or percentage) of immature basophils to total leukocytes in a biological specimen. A measurement of the total immature cells in a blood specimen.

Homovanillic Acid Measurement Howell-Jolly Body Measurement

C98740

Human Anti-Sheep IgE Antibody Human Anti-Sheep IgG Antibody Human Anti-Sheep IgM Antibody Hyaline Casts Hydrocodone Hydrogen Hydromorphone Hydroxyproline Hyperchromia Hypersegmented Cells Hypochromia

Human Anti-Sheep IgE Antibody Human Anti-Sheep IgG Antibody Human Anti-Sheep IgM Antibody Hyaline Casts Hydrocodone Hydrogen Hydromorphone Hydroxyproline Hyperchromia Hypersegmented Cells Hypochromia

Human Anti-Sheep IgE Antibody Measurement Human Anti-Sheep IgG Antibody Measurement Human Anti-Sheep IgM Antibody Measurement Hyaline Cast Measurement Hydrocodone Measurement Hydrogen Measurement Hydromorphone Measurement Hydroxyproline Measurement Hyperchromia Measurement Hypersegmented Neutrophil Measurement Hypochromia

C98741

C98742

C74770 C74879 C102275 C74880 C80190 C96669 C74612 C64802

C96670 C96671

Immature Basophils Immature Basophils/Leukocytes Immature Cells

Immature Basophils Immature Basophils/ Leukocytes Immature Cells

Immature Basophil Count Immature Basophil to Leukocyte Ratio Measurement Immature Cell Count

C96672

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 137 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Immature Eosinophils Immature Eosinophils/ Leukocytes Immature Granulocytes Immature Granulocytes/ Leukocytes Immature Lymphocytes Immature Lymphocytes/ Leukocytes Immature Monocytes Immature Monocytes/ Leukocytes Immature Neutrophils Immature Neutrophils/ Leukocytes Immature Plasma Cells Immature Plasma Cells/ Lymphocytes Immature Reticulocyte Fraction Immunoglobulin A Immunoglobulin D Immunoglobulin E Immunoglobulin G Immunoglobulin M Indican

NCI Code C96673 C96674

CDISC Submission Value Immature Eosinophils Immature Eosinophils/Leukocytes Immature Granulocytes Immature Granulocytes/Leukocytes Immature Lymphocytes Immature Lymphocytes/Leukocytes Immature Monocytes Immature Monocytes/Leukocytes Immature Neutrophils Immature Neutrophils/Leukocytes Immature Plasma Cells Immature Plasma Cells/Lymphocytes Immature Reticulocyte Fraction Immunoglobulin A Immunoglobulin D Immunoglobulin E Immunoglobulin G Immunoglobulin M Indican

CDISC Definition A measurement of the immature eosinophils in a biological specimen. A relative measurement (ratio or percentage) of immature eosinophils to total leukocytes in a biological specimen. A measurement of the total immature granulocytes in a biological specimen. A relative measurement (ratio or percentage) of the immature granulocytes to leukocytes in a biological specimen (for example a bone marrow specimen). A measurement of the immature lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the immature lymphocytes to leukocytes in a biological specimen. A measurement of the immature monocytes in a biological specimen. A relative measurement (ratio or percentage) of immature monocytes to total leukocytes in a biological specimen. A measurement of the total immature neutrophils in a biological specimen. A relative measurement (ratio or percentage) of the immature neutrophils to leukocytes in a biological specimen. A measurement of the immature plasma cells in a biological specimen. A relative measurement (ratio or percentage) of immature plasma cells to total lymphocytes in a biological specimen. A measurement of the immature reticulocyte fraction present in a biological specimen. A measurement of the Immunoglobulin A in a biological specimen. A measurement of the Immunoglobulin D in a biological specimen. A measurement of the Immunoglobulin E in a biological specimen. A measurement of the Immunoglobulin G in a biological specimen. A measurement of the Immunoglobulin M in a biological specimen. A measurement of the indican present in a biological specimen.

NCI Preferred Term Immature Eosinophil Count Immature Eosinophil to Leukocyte Ratio Measurement Immature Granulocyte Count Immature Granulocytes to Leukocytes Ratio Measurement Immature Lymphocytes Measurement Immature Lymphocytes to Leukocytes Ratio Measurement Immature Monocyte Count Immature Monocyte to Leukocyte Ratio Measurement Immature Neutrophil Count Immature Neutrophils to Leukocytes Ratio Measurement Immature Plasma Cell Count Immature Plasma Cell to Lymphocyte Ratio Measurement Immature Reticulocyte Fraction Measurement Immunoglobulin A Measurement Immunoglobulin D Measurement Immunoglobulin E Measurement Immunoglobulin G Measurement Immunoglobulin M Measurement Indican Measurement

C96675 C100445

C100444 C100443

C96676 C96677

C96678 C100442

C96679 C96680

C102276

C81969 C98745 C81970 C81971 C81972 C82044

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 138 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Indirect Bilirubin Influenza A H1N1 Viral Load Influenza A Viral Load Inhibin A Inhibin B Insulin Insulin-like Growth Factor-1 Insulin-like Growth Factor-2 Interferon Alpha Interferon Beta Interferon Gamma Interleukin 1 Interleukin 10 Interleukin 11 Interleukin 12 Interleukin 13 Interleukin 14 Interleukin 15 Interleukin 16 Interleukin 17 Interleukin 18 Interleukin 19

NCI Code C64483 C92273 C92274 C82020 C96681 C74788 C74864 C74865 C81994 C81995 C81996 C74805 C74806 C74807 C74808 C74809 C74810 C74811 C74812 C74813 C74814 C74815

CDISC Submission Value Indirect Bilirubin Influenza A H1N1 Viral Load Influenza A Viral Load Inhibin A Inhibin B Insulin Insulin-like Growth Factor-1 Insulin-like Growth Factor-2 Interferon Alpha Interferon Beta Interferon Gamma Interleukin 1 Interleukin 10 Interleukin 11 Interleukin 12 Interleukin 13 Interleukin 14 Interleukin 15 Interleukin 16 Interleukin 17 Interleukin 18 Interleukin 19

CDISC Definition A measurement of the unconjugated or non-water-soluble bilirubin in a biological specimen. A measurement of the Influenza A H1N1 viral load in a biological specimen. A measurement of the Influenza A viral load in a biological specimen. A measurement of the inhibin A in a biological specimen. A measurement of the inhibin B in a biological specimen. A measurement of the insulin in a biological specimen. A measurement of the insulin-like growth factor-1 in a biological specimen. A measurement of the insulin-like growth factor-2 in a biological specimen. A measurement of the interferon alpha in a biological specimen. A measurement of the interferon beta in a biological specimen. A measurement of the interferon gamma in a biological specimen. A measurement of the interleukin 1 in a biological specimen. A measurement of the interleukin 10 in a biological specimen. A measurement of the interleukin 11 in a biological specimen. A measurement of the interleukin 12 in a biological specimen. A measurement of the interleukin 13 in a biological specimen. A measurement of the interleukin 14 in a biological specimen. A measurement of the interleukin 15 in a biological specimen. A measurement of the interleukin 16 in a biological specimen. A measurement of the interleukin 17 in a biological specimen. A measurement of the interleukin 18 in a biological specimen. A measurement of the interleukin 19 in a biological specimen.

NCI Preferred Term Indirect Bilirubin Measurement Influenza A H1N1 Viral Load Measurement Influenza A Viral Load Measurement Inhibin A Measurement Inhibin B Measurement Insulin Measurement Insulin Like Growth Factor-1 Measurement Insulin Like Growth Factor-2 Measurement Interferon Alpha Measurement Interferon Beta Measurement Interferon Gamma Measurement Interleukin 1 Measurement Interleukin 10 Measurement Interleukin 11 Measurement Interleukin 12 Measurement Interleukin 13 Measurement Interleukin 14 Measurement Interleukin 15 Measurement Interleukin 16 Measurement Interleukin 17 Measurement Interleukin 18 Measurement Interleukin 19 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 139 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Interleukin 2 Interleukin 20 Interleukin 21 Interleukin 22 Interleukin 23 Interleukin 24 Interleukin 25 Interleukin 26 Interleukin 27 Interleukin 28 Interleukin 29 Interleukin 3 Interleukin 30 Interleukin 31 Interleukin 32 Interleukin 33 Interleukin 4 Interleukin 5 Interleukin 6 Interleukin 7 Interleukin 8 Interleukin 9

NCI Code C74816 C74817 C74818 C74819 C74820 C74821 C74822 C74823 C74824 C74825 C74826 C74827 C74828 C74829 C74830 C74831 C74832 C74833 C74834 C74835 C74836 C74837

CDISC Submission Value Interleukin 2 Interleukin 20 Interleukin 21 Interleukin 22 Interleukin 23 Interleukin 24 Interleukin 25 Interleukin 26 Interleukin 27 Interleukin 28 Interleukin 29 Interleukin 3 Interleukin 30 Interleukin 31 Interleukin 32 Interleukin 33 Interleukin 4 Interleukin 5 Interleukin 6 Interleukin 7 Interleukin 8 Interleukin 9

CDISC Definition A measurement of the interleukin 2 in a biological specimen. A measurement of the interleukin 20 in a biological specimen. A measurement of the interleukin 21 in a biological specimen. A measurement of the interleukin 22 in a biological specimen. A measurement of the interleukin 23 in a biological specimen. A measurement of the interleukin 24 in a biological specimen. A measurement of the interleukin 25 in a biological specimen. A measurement of the interleukin 26 in a biological specimen. A measurement of the interleukin 27 in a biological specimen. A measurement of the interleukin 28 in a biological specimen. A measurement of the interleukin 29 in a biological specimen. A measurement of the interleukin 3 in a biological specimen. A measurement of the interleukin 30 in a biological specimen. A measurement of the interleukin 31 in a biological specimen. A measurement of the interleukin 32 in a biological specimen. A measurement of the interleukin 33 in a biological specimen. A measurement of the interleukin 4 in a biological specimen. A measurement of the interleukin 5 in a biological specimen. A measurement of the interleukin 6 in a biological specimen. A measurement of the interleukin 7 in a biological specimen. A measurement of the interleukin 8 in a biological specimen. A measurement of the interleukin 9 in a biological specimen.

NCI Preferred Term Interleukin 2 Measurement Interleukin 20 Measurement Interleukin 21 Measurement Interleukin 22 Measurement Interleukin 23 Measurement Interleukin 24 Measurement Interleukin 25 Measurement Interleukin 26 Measurement Interleukin 27 Measurement Interleukin 28 Measurement Interleukin 29 Measurement Interleukin 3 Measurement Interleukin 30 Measurement Interleukin 31 Measurement Interleukin 32 Measurement Interleukin 33 Measurement Interleukin 4 Measurement Interleukin 5 Measurement Interleukin 6 Measurement Interleukin 7 Measurement Interleukin 8 Measurement Interleukin 9 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 140 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Inulin Clearance

NCI Code C98748

CDISC Submission Value Inulin Clearance

CDISC Definition A measurement of the volume of serum or plasma that would be cleared of inulin by excretion of urine for a specified unit of time (e.g. one minute). A measurement of the volume of serum or plasma that would be cleared of Iohexol through excretion for a specified unit of time. A measurement of the volume of serum or plasma that would be cleared of iothalamate by excretion of urine for a specified unit of time (e.g. one minute). A measurement of the volume of serum or plasma that would be cleared of iothalamate by excretion of urine for a specified unit of time (e.g. one minute), adjusted for body size. A measurement of the iron in a biological specimen. A measurement of the islet cell 512 antibody in a biological specimen. A measurement of the islet cell 512 antigen in a biological specimen. A measurement of the islet neogenesis associated protein antibody in a biological specimen. A measurement of the Jo-1 antibody in a biological specimen. A measurement of the free kappa light chain in a biological specimen. A relative measurement (ratio or percentage) of the free kappa light chain to the free lambda light chain in a biological specimen. A measurement of the ketones in a biological specimen. A measurement of the kidney injury molecule-1 (Kim-1) in a biological specimen.

NCI Preferred Term Inulin Clearance

C100439

Iohexol Clearance

Iohexol Clearance Iothalamate Clearance Iothalamate Clearance Adjusted for BSA Iron; FE Islet Cell 512 Antibody Islet Cell 512 Antigen Islet Neogenesis Assoc Protein Antibody Jo-1 Antibody Kappa Light Chain, Free Kappa Lt Chain,Free/ Lambda Lt Chain,Free Ketones Kidney Injury Molecule-1; KIM-1; Hepatitis A Virus Cellular Receptor 1 Kurloff Cells

Iohexol Clearance

C98749

Iothalamate Clearance

Iothalamate Clearance

C98750

Iothalamate Clearance Adjusted for BSA

Iothalamate Clearance Adjusted for BSA

C74679 C81985 C81986 C81987

Iron Islet Cell 512 Antibody Islet Cell 512 Antigen Islet Neogenesis Assoc Protein Antibody Jo-1 Antibody Kappa Light Chain, Free Kappa Lt Chain,Free/Lambda Lt Chain,Free

Iron Measurement Islet Cell 512 Antibody Measurement Islet Cell 512 Antigen Measurement Islet Neogenesis Associated Protein Antibody Measurement Jo-1 Antibody Measurement Free Kappa Light Chain Measurement Free Kappa Light Chain to Free Lambda Light Chain Ratio Measurement Ketone Measurement Kidney Injury Molecule-1 Measurement

C100459 C98730 C98731

C64854 C100433

Ketones Kidney Injury Molecule-1

C96682

Kurloff Cells

A measurement of the large secretory granule-containing immune cells in a biological specimen taken from members of certain genera of the Caviidae family. A measurement of the lactate dehydrogenase isoenzyme 1 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 1 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 2 in a biological specimen.

Kurloff Cells Measurement

C74887 C79451

LDH Isoenzyme 1 LDH Isoenzyme 1/LDH

LDH Isoenzyme 1 LDH Isoenzyme 1/LDH LDH Isoenzyme 2

Lactate Dehydrogenase Isoenzyme 1 Measurement LDH Isoenzyme 1 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 2 Measurement

C74888

LDH Isoenzyme 2

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 141 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym LDH Isoenzyme 2/LDH LDH Isoenzyme 3 LDH Isoenzyme 3/LDH LDH Isoenzyme 4 LDH Isoenzyme 4/LDH LDH Isoenzyme 5 LDH Isoenzyme 5/LDH LDL Cholesterol Lactate Dehydrogenase Lactate Dehydrogenase/ Creatinine Lactic Acid; 2-hydroxypropan oic acid; Lactate Lactoferrin; Lactotransferrin Lambda Light Chain, Free Large Platelets Large Unstained Cells

NCI Code C79452

CDISC Submission Value LDH Isoenzyme 2/LDH

CDISC Definition A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 2 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 3 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 3 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 4 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 4 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 5 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 5 to total lactate dehydrogenase in a biological specimen. A measurement of the low density lipoprotein cholesterol in a biological specimen. A measurement of the lactate dehydrogenase in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase to creatinine in a biological specimen. A measurement of the lactic acid in a biological specimen. A measurement of the lactoferrin in a biological specimen. A measurement of the free lambda light chain in a biological specimen. A measurement of the large (between 4 um and 7um in diameter) platelets in a biological specimen. A measurement of the large, peroxidase-negative cells which cannot be further characterized (i.e. as large lymphocytes, virocytes, or stem cells) present in a biological specimen. A relative measure (ratio or percentage) of the large unstained cells to leukocytes in a biological specimen. A measurement of the Legionella pneumophila antigen in a biological specimen. A measurement of the Legionella pneumophila IgG antibody in a biological specimen.

NCI Preferred Term LDH Isoenzyme 2 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 3 Measurement LDH Isoenzyme 3 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 4 Measurement LDH Isoenzyme 4 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 5 Measurement LDH Isoenzyme 5 to LDH Ratio Measurement Serum LDL Cholesterol Measurement Lactate Dehydrogenase Measurement Lactate Dehydrogenase to Creatinine Ratio Measurement Lactic Acid Measurement

C74889 C79453

LDH Isoenzyme 3 LDH Isoenzyme 3/LDH

C74890 C79454

LDH Isoenzyme 4 LDH Isoenzyme 4/LDH

C74891 C79455

LDH Isoenzyme 5 LDH Isoenzyme 5/LDH

C61042 C64855 C79449

LDL Cholesterol Lactate Dehydrogenase Lactate Dehydrogenase/Creatinine Lactic Acid

C79450

C82021 C98732 C74729 C74659

Lactoferrin Lambda Light Chain, Free Large Platelets Large Unstained Cells

Lactoferrin Measurement Free Lambda Light Chain Measurement Large Platelet Count Large Unstained Cell Count

C79467

Large Unstained Cells/Leukocytes Legionella pneumophila Antigen Legionella pneumophila IgG Antibody

Large Unstained Cells/ Leukocytes Legionella pneumophila Antigen Legionella pneumophila IgG Antibody

Large Unstained Cells to Leukocytes Ratio Measurement Legionella pneumophila Antigen Measurement Legionella pneumophila IgG Antibody Measurement

C92275

C92276

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 142 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Legionella pneumophila IgG IgM Antibody

NCI Code C92277

CDISC Submission Value Legionella pneumophila IgG IgM Antibody Legionella pneumophila IgM Antibody Leptin Leucine Crystals Leukemic Blasts

CDISC Definition A measurement of the Legionella pneumophila IgG and IgM in a biological specimen.

NCI Preferred Term Legionella pneumophila IgG IgM Antibody Measurement Legionella pneumophila IgM Antibody Measurement Leptin Measurement Leucine Crystal Measurement Leukemic Blast Count

C92278

Legionella A measurement of the Legionella pneumophila IgM pneumophila IgM antibody in a biological specimen. Antibody Leptin Leucine Crystals Leukemic Blasts; Leukemic Lymphoblasts; Immunoblastic Lymphocytes Leukemic Blasts/ Lymphocytes Leukocyte Cell Clumps; White Blood Cell Clumps; WBC Clumps Leukocyte Cell Morphology; White Blood Cell Morphology; WBC Morphology Leukocyte Esterase Leukocytes; White Blood Cells Lipoprotein-a Liver Kidney Microsomal Type 1 Antibody; LKM-1 Liver Kidney Microsomal Type 1 IgA Ab Liver Kidney Microsomal Type 1 IgG Ab A measurement of the leptin hormone in a biological specimen. A measurement of the leucine crystals present in a biological specimen. A measurement of the leukemic blasts (lymphoblasts that remain in an immature state even when outside the bone marrow) in a biological specimen.

C74866 C74680 C74630

C74641

Leukemic Blasts/Lymphocytes Leukocyte Cell Clumps

A relative measurement (ratio or percentage) of the leukemic blasts (immature lymphoblasts) to mature lymphocytes in a biological specimen. A measurement of white blood cell clumps in a biological specimen.

Leukemic Blast to Lymphocyte Ratio Measurement Leukocyte Cell Clumps Measurement

C92246

C92297

Leukocyte Cell Morphology

An examination or assessment of the form and structure of white blood cells.

Leukocyte Cell Morphology

C64856

Leukocyte Esterase

A measurement of the enzyme which indicates the presence of white blood cells in a biological specimen. A measurement of the leukocytes in a biological specimen. A measurement of the lipoprotein-a in a biological specimen. A measurement of the liver kidney microsomal type 1 antibody in a biological specimen.

Leukocyte Esterase Measurement

C51948

Leukocytes

Leukocyte Count

C82022 C96683

Lipoprotein-a Liver Kidney Microsomal Type 1 Antibody

Lipoprotein a Measurement Liver Kidney Microsomal Type 1 Antibody Measurement

C100456

Liver Kidney Microsomal Type 1 IgA Ab Liver Kidney Microsomal Type 1 IgG Ab

A measurement of the liver kidney microsomal type 1 IgA antibodies in a biological specimen. A measurement of the liver kidney microsomal type 1 IgG antibodies in a biological specimen.

Liver Kidney Microsomal Type 1 IgA Antibody Measurement Liver Kidney Microsomal Type 1 IgG Antibody Measurement

C100454

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 143 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Liver Kidney Microsomal Type 1 IgM Ab Lupus Anticoagulant Sensitive APTT; APPT-LA Luteinizing Hormone Lymphoblasts

NCI Code C100455

CDISC Submission Value Liver Kidney Microsomal Type 1 IgM Ab Lupus Anticoagulant Sensitive APTT

CDISC Definition A measurement of the liver kidney microsomal type 1 IgM antibodies in a biological specimen. A measurement of the length of time that it takes for clotting to occur when a lupus sensitive reagent is added to a plasma specimen. A measurement of the luteinizing hormone in a biological specimen. A measurement of the lymphoblasts (immature cells that differentiate to form lymphocytes) in a biological specimen. A measurement of the lymphocytes in a biological specimen. A measurement of the atypical lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the lymphocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the malignant lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the malignant lymphocytes to all lymphocytes in a biological specimen. A measurement of the lymphotactin in a biological specimen. A measurement of the amount of interferon gamma that is released when Mycobacterium tuberculosis antigen is incubated with a biological specimen, usually blood. Increased amounts of interferon gamma suggests a prior or existing M. tuberculosis infection. A measurement of the macrocytes in a biological specimen. A measurement of the macrophage colony stimulating factor in a biological specimen.

NCI Preferred Term Liver Kidney Microsomal Type 1 IgM Antibody Measurement Lupus Anticoagulant Sensitive APTT Measurement

C102277

C74790 C102278

Luteinizing Hormone Lymphoblasts

Luteinizing Hormone Measurement Lymphoblast Count

C51949 C64818 C64819

Lymphocytes Lymphocytes Atypical Lymphocytes Atypical/Leukocytes Lymphocytes/Leukocytes Lymphocytes/Total Cells

Lymphocytes Lymphocytes Atypical Lymphocytes Atypical/ Leukocytes Lymphocytes/ Leukocytes Lymphocytes/ Total Cells Lymphoma Cells Lymphoma Cells/ Lymphocytes Lymphotactin; Chemokine Ligand 1 Mycobacterium tuberculosis IFN Gamma Response Macrocytes Macrophage Colony Stimulating Factor Macrophage Inflammatory Protein 1 Alpha; Chemokine Ligand 3

Lymphocyte Count Atypical Lymphocyte Count Atypical Lymphocyte To Leukocyte Ratio Lymphocyte To Leukocyte Ratio Lymphocyte to Total Cell Ratio Measurement Lymphoma Cell Count Lymphoma Cell to Lymphocyte Ratio Measurement Lymphotactin Measurement

C64820 C98751

C74613 C74910

Lymphoma Cells Lymphoma Cells/Lymphocytes Lymphotactin

C81955

C92241

M. tuberculosis IFN Gamma Response

Mycobacterium tuberculosis Interferon Gamma Response

C64821 C80191

Macrocytes Macrophage Colony Stimulating Factor

Macrocyte Count Macrophage Colony Stimulating Factor Measurement

C82023

Macrophage Inflammatory Protein 1 Alpha

A measurement of the macrophage inflammatory protein 1 alpha in a biological specimen.

Macrophage Inflammatory Protein 1 Alpha Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 144 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Macrophage Inflammatory Protein 1 Beta; Chemokine Ligand 4 Macrophage-Der ived Chemokine; Chemokine Ligand 22 Magnesium Magnesium/ Creatinine Malignant Cells, NOS Malignant Cells, NOS/Blood Cells Matrix Metalloproteinas e 1; Interstitial Collagenase Matrix Metalloproteinas e 2; Gelatinase A Matrix Metalloproteinas e 3; Stromelysin 1 Matrix Metalloproteinas e 7; Matrilysin Matrix Metalloproteinas e 8; Neutrophil Collagenase Matrix Metalloproteinas e 9; Gelatinase B Mature Plasma Cells; Plasmacytes Mature Plasma Cells/ Lymphocytes May-Hegglin Anomaly

NCI Code C82024

CDISC Submission Value Macrophage Inflammatory Protein 1 Beta

CDISC Definition A measurement of the macrophage inflammatory protein 1 beta in a biological specimen.

NCI Preferred Term Macrophage Inflammatory Protein 1 Beta Measurement

C81956

Macrophage-Derived Chemokine

A measurement of the macrophage-derived chemokine in a biological specimen.

Macrophage-Derived Chemokine Measurement

C64840 C79456 C74660 C74643

Magnesium Magnesium/Creatinine Malignant Cells, NOS Malignant Cells, NOS/Blood Cells Matrix Metalloproteinase 1

A measurement of the magnesium in a biological specimen. A relative measurement (ratio or percentage) of the magnesium to creatinine in a biological specimen. A measurement of the malignant cells of all types in a biological specimen. A relative measurement (ratio or percentage) of the malignant cells of all types to all blood cells in a biological specimen. A measurement of the matrix metalloproteinase 1 in a biological specimen.

Magnesium Measurement Magnesium to Creatinine Ratio Measurement Malignant Cell Count Malignant Cell to Blood Cell Ratio Measurement Matrix Metalloproteinase 1 Measurement

C80192

C80193

Matrix Metalloproteinase 2

A measurement of the matrix metalloproteinase 2 in a biological specimen. A measurement of the matrix metalloproteinase 3 in a biological specimen.

Matrix Metalloproteinase 2 Measurement Matrix Metalloproteinase 3 Measurement

C80194

Matrix Metalloproteinase 3

C80195

Matrix Metalloproteinase 7

A measurement of the matrix metalloproteinase 7 in a biological specimen. A measurement of the matrix metalloproteinase 8 in a biological specimen.

Matrix Metalloproteinase 7 Measurement Matrix Metalloproteinase 8 Measurement

C80196

Matrix Metalloproteinase 8

C80197

Matrix Metalloproteinase 9

A measurement of the matrix metalloproteinase 9 in a biological specimen. A measurement of the mature plasma cells (plasmacytes) in a biological specimen. A relative measurement (ratio or percentage) of the mature plasma cells (plasmacytes) to all lymphocytes in a biological specimen. A measurement of the May-Hegglin anomaly in a blood sample. This anomaly is characterized by large, misshapen platelets and the presence of Dohle bodies in leukocytes.

Matrix Metalloproteinase 9 Measurement Mature Plasma Cell Count

C74661

Mature Plasma Cells

C74911

Mature Plasma Cells/Lymphocytes May-Hegglin Anomaly

Mature Plasma Cell to Lymphocyte Ratio Measurement May-Hegglin Anomaly Measurement

C74614

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 145 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Mean Platelet Component Mean Platelet Volume Megakaryoblasts Megakaryoblasts /Total Cells Megakaryocytes Megakaryocytes/ Total Cells Melatonin Metamyelocytes

NCI Code C96686 C74730 C98752 C98753

CDISC Submission Value Mean Platelet Component Mean Platelet Volume Megakaryoblasts Megakaryoblasts/Total Cells

CDISC Definition A measurement of the mean platelet component (platelet activity) in a blood specimen. A measurement of the average size of the platelets present in a blood sample. A measurement of the megakaryoblasts in a biological specimen. A relative measurement (ratio or percentage) of the megakaryoblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the megakaryocytes per unit of a biological specimen. A relative measurement (ratio or percentage) of the megakaryocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the melatonin hormone in a biological specimen. A measurement of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) in a biological specimen. A relative measurement (ratio or percentage) of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) to all leukocytes in a biological specimen. A relative measurement (ratio or percentage ) of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the methadone present in a biological specimen. A measurement of the methamphetamine drug present in a biological specimen. A measurement of the methaqualone present in a biological specimen. A measurement of the methemoglobin in a biological specimen. A measurement of the methylmalonic acid in a biological specimen. A measurement of the microcytes in a biological specimen. A measurement of the mixed (the cast contains a mixture of cell types) casts present in a biological specimen. A measurement of the monoblast cells in a biological specimen. A relative measurement (ratio or percentage) of the monoblasts to leukocytes in a biological specimen.

NCI Preferred Term Mean Platelet Component Measurement Mean Platelet Volume Measurement Megakaryoblast Cell Count Megakaryoblast to Total Cell Ratio Measurement Megakaryocyte Count Megakaryocyte to Total CellRatio Measurement Melatonin Measurement Metamyelocyte Count

C96688 C98867

Megakaryocytes Megakaryocytes/Total Cells

C74867 C74615

Melatonin Metamyelocytes

C74645

Metamyelocytes/Leukocytes

Metamyelocytes/ Leukocytes

Metamyelocyte to Leukocyte Ratio Measurement

C98754

Metamyelocytes/Total Cells

Metamyelocytes/ Total Cells

Metamyelocyte to Total Cell Ratio Measurement

C74881 C75348 C74882 C96689 C96690 C64822 C74771

Methadone Methamphetamine Methaqualone Methemoglobin Methylmalonic Acid Microcytes Mixed Casts

Methadone Methamphetamin e Methaqualone Methemoglobin Methylmalonic Acid Microcytes Mixed Casts

Methadone Measurement Methamphetamine Measurement Methaqualone Measurement Methemoglobin Measurement Methylmalonic Acid Measurement Microcyte Count Mixed Cast Count

C74631 C74646

Monoblasts Monoblasts/Leukocytes

Monoblasts Monoblasts/ Leukocytes

Monoblast Count Monoblast to Leukocyte Ratio Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 146 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Monoclonal Immunoglobulin Protein; Paraprotein Monocyte Chemotactic Protein 1 Monocytes Monocytes/ Leukocytes Monocytes/Total Cells Monosodium Urate Crystals Morphine Mu Glutathione-S-Tr ansferase Mu Glutathione-S-Tr ansferase/ Creatinine Mucous Threads Mycobacterium tuberculosis Nucleic Acid Myeloblasts Myeloblasts/ Leukocytes Myeloblasts/ Total Cells Myelocytes Myelocytes/ Leukocytes Myelocytes/ Total Cells Myeloid/ Erythroid Ratio

NCI Code C92291

CDISC Submission Value Monoclonal Protein

CDISC Definition A measurement of homogenous immunoglobulin resulting from the proliferation of a single clone of plasma cells in a biological specimen. A measurement of the monocyte chemotactic protein 1 in a biological specimen. A measurement of the monocytes in a biological specimen. A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the monocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the monosodium urate crystals present in a biological specimen. A measurement of the morphine present in a biological specimen. A measurement of the mu form of glutathione S-transferase in a biological specimen. A relative measurement (ratio or percentage) of the mu gamma glutamyl transpeptidase to creatinine in a biological specimen. A measurement of the mucous threads present in a biological specimen. A measurement of the Mycobacterium tuberculosis nucleic acid in a biological specimen. A measurement of the myeloblast cells in a biological specimen. A relative measure (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the myeloblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the myelocytes in a biological specimen. A relative measurement (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the myelocytes to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of myeloid progenitor cells to erythrocyte precursor cells in a biological specimen.

NCI Preferred Term Monoclonal Protein Measurement

C82025

Monocyte Chemotactic Protein 1 Monocytes Monocytes/Leukocytes Monocytes/Total Cells

Monocyte Chemotactic Protein 1 Measurement Monocyte Count Monocyte To Leukocyte Ratio Monocytes to Total CellRatioMeasurement Monosodium Urate Crystal Measurement Morphine Measurement Mu Glutathione-S-Transferase Measurement Mu Glutathione-S-Transferase to Creatinine Ratio Measurement

C64823 C64824 C98872

C74681 C74883 C79457

Monosodium Urate Crystals Morphine Mu Glutathione-S-Transferase

C79458

Mu Glutathione-S-Transferase/ Creatinine Mucous Threads Mycobacterium tuberculosis Nucleic Acid Myeloblasts Myeloblasts/Leukocytes Myeloblasts/Total Cells

C74721 C92279

Mucous Thread Measurement Mycobacterium tuberculosis Nucleic Acid Measurement Myeloblast Count Myeloblast To Leukocyte Ratio Myeloblast to Total Cell Ratio Measurement Myelocyte Count Myelocyte To Leukocyte Ratio Myelocyte to Total CellRatio Measurement Myeloid to Erythroid Ratio Measurement

C74632 C64825 C98761

C74662 C64826 C98868

Myelocytes Myelocytes/Leukocytes Myelocytes/Total Cells

C92242

Myeloid/Erythroid Ratio

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 147 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Myeloperoxidase Myeloperoxidase Antibody Myoglobin N-Acetyl Glucosamide; N-Acetyl Glucosamine N-Acetyl Glucosamide/ Creatinine N-Terminal ProB-type Natriuretic Peptide; NT proBNP II; N-terminal pro-Brain Natriuretic Peptide N-telopeptide Natural Killer Cells Neisseria gonorrhoeae Screening Neopterin Neuropeptide Y Neutrophil Elastase Neutrophil Elastase, Polymorphonucl ear Neutrophilic Metamyelocytes Neutrophilic Myelocytes Neutrophils Neutrophils Band Form

NCI Code C80198 C92280 C79436 C79459

CDISC Submission Value Myeloperoxidase Myeloperoxidase Antibody Myoglobin N-Acetyl Glucosamide

CDISC Definition A measurement of the myeloperoxidase in a biological specimen. A measurement of the myeloperoxidase antibody in a biological specimen. A measurement of myoglobin in a biological specimen. A measurement of N-acetyl glucosamide in a biological specimen.

NCI Preferred Term Myeloperoxidase Measurement Myeloperoxidase Antibody Measurement Myoglobin Measurement N-Acetyl Glucosamide Measurement

C79460

N-Acetyl Glucosamide/Creatinine N-Terminal ProB-type Natriuretic Peptide

A relative measurement (ratio or percentage) of the N-acetyl glucosamide to creatinine in a biological specimen. A measurement of the N-terminal proB-type natriuretic peptide in a biological specimen.

N-Acetyl Glucosamide to Creatinine Ratio Measurement N-Terminal ProB-type Natriuretic Peptide Measurement

C96610

C74743 C98762 C92298

N-telopeptide Natural Killer Cells Neisseria gonorrhoeae Screening Neopterin Neuropeptide Y Neutrophil Elastase Neutrophil Elastase, Polymorphonuclear

A measurement of the N-telopeptide in a biological specimen. A measurement of the total natural killer cells in a biological specimen. Examination of a biological specimen to detect the presence of Neisseria gonorrhoeae. A measurement of the neopterin in a biological specimen. A measurement of the neuropeptide Y in a biological specimen. A measurement of the neutrophil elastase in a biological specimen. A measurement of the polymorphonuclear neutrophil elastase in a biological specimen.

N-telopeptide Measurement Natural Killer Cell Count Neisseria gonorrhoeae Screening

C80199 C74892 C82026 C82027

Neopterin Measurement Neuropeptide Y Measurement Neutrophil Elastase Measurement Polymorphonuclear Neutrophil Elastase Measurement

C84822 C84823 C63321 C64830

Neutrophilic Metamyelocytes Neutrophilic Myelocytes Neutrophils Neutrophils Band Form

A measurement of the neutrophilic metamyelocytes in a biological specimen. A measurement of the neutrophilic myelocytes in a biological specimen. A measurement of the neutrophils in a biological specimen. A measurement of the banded neutrophils in a biological specimen.

Neutrophilic Metamyelocyte Count Neutrophilic Myelocyte Count Absolute Neutrophil Count Neutrophil Band Form Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 148 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Neutrophils Band Form/ Leukocytes Neutrophils, Segmented Neutrophils, Segmented/ Leukocytes Neutrophils/ Leukocytes Neutrophils/ Total Cells Niacin; Vitamin B3 Nitrite Non-Phosphoryl ated Tau Protein Non-Prostatic Acid Phosphatase Noradrenaline; Norepinephrine Normoblasts/ Total Cells Nucleated Erythrocytes; Nucleated Red Blood Cells Nucleated Erythrocytes/ Erythrocytes; Nucleated Red Blood Cells/ Erythrocytes Nucleated Erythrocytes/ Leukocytes Occult Blood Opiate Osmolality Osmolarity

NCI Code C64831

CDISC Submission Value Neutrophils Band Form/Leukocytes Neutrophils, Segmented Neutrophils, Segmented/Leukocytes Neutrophils/Leukocytes Neutrophils/Total Cells

CDISC Definition A relative measurement (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. A measurement of the segmented neutrophils in a biological specimen. A relative measurement (ratio or percentage) of segmented neutrophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the neutrophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the niacin in a biological specimen. A measurement of the nitrite in a urine specimen. A measurement of the non-phosphorylated Tau protein in a biological specimen. A measurement of the non-prostatic acid phosphatase in a biological specimen. A measurement of the norepinephrine hormone in a biological specimen. A relative measurement (ratio or percentage) of the normoblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the nucleated erythrocytes (large, immature nucleated erythrocytes) in a biological specimen. A relative measurement (ratio or percentage) of the nucleated erythrocytes (large, immature nucleated erythrocytes) to all erythrocytes in a biological specimen.

NCI Preferred Term Neutrophil Band Form To Leukocyte Ratio Segmented Neutrophil Count Segmented Neutrophil to Leukocyte Ratio Measurement Neutrophil To Leukocyte Ratio Neutrophil to Total Cell Ratio Measurement Vitamin B3 Measurement Nitrite Measurement Nonphosphorylated Tau Protein Measurement Non-Prostatic Acid Phosphatase Measurement Noradrenaline Measurement Normoblast to Total Cell Ratio Measurement Nucleated Red Blood Cell Count

C81997 C82045

C64827 C98763

C74899 C64810 C84811 C100434

Niacin Nitrite Non-Phosphorylated Tau Protein Non-Prostatic Acid Phosphatase Norepinephrine Normoblasts/Total Cells

C74868 C98764

C74705

Nucleated Erythrocytes

C74647

Nucleated Erythrocytes/Erythrocytes

Nucleated Red Blood Cell to Erythrocyte Ratio Measurement

C82046

Nucleated Erythrocytes/Leukocytes Occult Blood Opiate Osmolality Osmolarity

A relative measurement (ratio or percentage) of nucleated erythrocytes to leukocytes in a biological specimen. A measurement of the blood in body products such as a stool sample, not detectable on gross examination. A measurement of any opiate class drug present in a biological specimen. A measurement of the osmoles of solute per unit of biological specimen. A measurement of the osmoles of solute per liter of solution.

Nucleated Erythrocyte to Leukocyte Ratio Measurement Occult Blood Measurement Opiate Measurement Osmolality Measurement Osmolarity Measurement

C74686 C74796 C74801 C74802

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 149 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Osteocalcin Measurement Ova and Parasite Measurement Oxalate Measurement Oxycodone Measurement Oxygen Capacity Measurement

NCI CodeCDISC Submission Value C74744 C100452 C92250 C74884 C96614

OsteocalcinOsteocalcinA measurement of the osteocalcin in a biological specimen. Ova and ParasiteOva and ParasiteA measurement of the parasites and ova in a biological specimen. OxalateOxalate; Ethanedioate OxycodoneOxycodone; Oxycontin A measurement of the oxalate in a biological specimen. A measurement of the oxycodone present in a biological specimen.

Oxygen CapacityOxygen CapacityA measurement of the maximum amount of oxygen that can be combined chemically with hemoglobin in a volume of blood. Saturation A measurement of the oxygen-hemoglobin saturation of a volume of blood.

C68032Oxygen SaturationOxygen C96616 C74869 C102279 C82028 C82029

Oxygen Saturation Measurement Oxyhemoglobin Measurement Oxytocin Measurement P50 Oxygen Measurement Pancreatic Elastase Measurement Polymorphonuclear Pancreatic Elastase Measurement

OxyhemoglobinOxyhemoglobinA measurement of the oxyhemoglobin in a biological specimen. OxytocinOxytocin; Oxytoxin A measurement of the oxytocin hormone in a biological specimen.

P50 OxygenP50 OxygenA measurement of the partial pressure of oxygen when hemoglobin is half saturated in a biological specimen. Pancreatic Elastase 1Pancreatic Elastase 1 Pancreatic Elastase 1, Polymorphonuclear Pancreatic Elastase 1, Polymorphonucl ear Polypeptide A measurement of the pancreatic elastase 1 in a biological specimen. A measurement of the polymorphonuclear pancreatic elastase 1 in a biological specimen.

C80201Pancreatic PolypeptidePancreatic C74616Pappenheimer BodiesPappenheimer Bodies

A measurement of the pancreatic polypeptide in a biological specimen. A measurement of the cells containing Pappenheimer Bodies (violet or blue staining ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. A measurement of the C-terminal fragment of parathyroid hormone in a biological specimen. A measurement of the fragmented parathyroid hormone in a biological specimen. A measurement of the intact parathyroid hormone in a biological specimen. A measurement of the mid-molecule fragment of parathyroid hormone in a biological specimen. A measurement of the N-terminal fragment of parathyroid hormone in a biological specimen. A measurement of the pressure of carbon dioxide in a biological specimen.

Pancreatic Polypeptide Measurement Pappenheimer Body Count

C81964

Parathyroid Hormone, C-Terminal Parathyroid Hormone, Fragmented

Parathyroid Hormone, C-Terminal Parathyroid Hormone, Fragmented

C-Terminal Parathyroid Hormone Measurement Fragmented Parathyroid Hormone Measurement Intact Parathyroid Hormone Measurement Mid-Molecule Parathyroid Hormone Measurement N-Terminal Parathyroid Hormone Measurement Partial Pressure of Carbon Dioxide Measurement

C74784

C74789

Parathyroid Hormone, IntactParathyroid Hormone, Intact Parathyroid Hormone, Mid-Molecule Parathyroid Hormone, N-Terminal Partial Pressure Carbon Dioxide

C81965Parathyroid Hormone, Mid-Molecule C81966 Parathyroid Hormone, N-Terminal Partial Pressure Carbon Dioxide

C82625

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


Source Date: 2012-06-29 - page 150 of 512 -A>

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Partial Pressure Oxygen Parvovirus B19 IgG Antibody Parvovirus B19 IgM Antibody Pelger Huet Anomaly Pemphigoid Antibodies Pepsinogen Pepsinogen A; PGA Pepsinogen C; PGC Pepsinogen I; PGI Pepsinogen II; PGII Peptide YY; Peptide Tyrosine Tyrosine Phencyclidine; Phenylcyclohexy lpiperidine Phenothiazine; Dibenzothiazine Phosphate; Phosphorus; Inorganic Phosphate Phosphate/ Creatinine Phospholipid Phosphorylated Tau Protein Plasma Cells/Total Cells

NCI Code C71251 C96617 C96618 C74617

CDISC Submission Value Partial Pressure Oxygen Parvovirus B19 IgG Antibody Parvovirus B19 IgM Antibody Pelger Huet Anomaly

CDISC Definition A measurement of the pressure of oxygen in a biological specimen. A measurement of the Parvovirus B19 IgG antibody in a biological specimen. A measurement of the Parvovirus B19 IgM antibody in a biological specimen. A measurement of the Pelger Huet Anomaly (nuclei of neutrophils and eosinophils appear rod-like, spherical or dumbbell shaped) in a biological specimen. A measurement of the pemphigoid antibodies in a biological specimen. A measurement of the pepsinogen in a biological specimen. A measurement of the pepsinogen A in a biological specimen. A measurement of the pepsinogen C in a biological specimen. A measurement of the pepsinogen I in a biological specimen. A measurement of the pepsinogen II in a biological specimen. A measurement of the peptide YY in a biological specimen. A measurement of the phencyclidine present in a biological specimen. A measurement of the phenothiazine present in a biological specimen. A measurement of the phosphate in a biological specimen.

NCI Preferred Term Partial Pressure of Oxygen Measurement Parvovirus B19 IgG Antibody Measurement Parvovirus B19 IgM Antibody Measurement Pelger Huet Anomaly Measurement

C81988 C100122 C100469 C100470 C100467 C100468 C80202

Pemphigoid Antibodies Pepsinogen Pepsinogen A Pepsinogen C Pepsinogen I Pepsinogen II Peptide YY

Pemphigoid Antibody Measurement Pepsinogen Measurement Pepsinogen A Measurement Pepsinogen C Measurement Pepsinogen I Measurement Pepsinogen II Measurement Peptide YY Measurement

C74694

Phencyclidine

Phencyclidine Measurement

C74695 C64857

Phenothiazine Phosphate

Phenothiazine Measurement Phosphate Measurement

C79461 C96623 C84812 C98869

Phosphate/Creatinine Phospholipid Phosphorylated Tau Protein Plasma Cells/Total Cells

A relative measurement (ratio or percentage) of the phosphate to creatinine in a biological specimen. A measurement of the phospholipids in a biological specimen. A measurement of the phosphorylated Tau protein in a biological specimen. A relative measurement (ratio or percentage) of the mature plasma cells (plasmacytes) to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the plasmacytoid lymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) in a biological specimen.

Phosphate to Creatinine Ratio Measurement Phospholipid Measurement Phosphorylated Tau Protein Measurement Plasma Cell to Total CellRatio Measurement

C74618

Plasmacytoid Lymphocytes

Plasmacytoid Lymphocytes; Plymphocytes

Plasmacytoid Lymphocyte Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 151 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Plasmacytoid Lymphocytes/ Lymphocytes

NCI Code C74648

CDISC Submission Value Plasmacytoid Lymphocytes/Lymphocytes

CDISC Definition A relative measurement (ratio or percentage) of the plasmacytoid lymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) to all lymphocytes in a biological specimen. A measurement of the plasminogen activator inhibitor-1 in a biological specimen. A measurement of the plasminogen activator inhibitor-1 antigen in a biological specimen. Examination of a biological specimen to detect the presence of any protozoan belonging to the Plasmodium genus. A measurement of the platelet clumps in a biological specimen. A measurement of the range of platelet sizes in a biological specimen. A relative measurement (ratio or percentage) of the proportion of the volume of blood taken up by platelets. A measurement of the platelets in a biological specimen. A measurement of the odd-shaped erythrocytes in a whole blood specimen. A relative measurement (ratio or percentage) of the poikilocytes, or irregularly shaped erythrocytes, to all erythrocytes in a biological specimen. A measurement of the blue-staining characteristic of newly generated erythrocytes. A measurement of the potassium in a biological specimen. A relative measurement (ratio or percentage) of the potassium to creatinine in a biological specimen. A measurement of the prealbumin in a biological specimen. A measurement of the precursor (blast stage) plasma cells (antibody secreting cells derived from B cells via antigen stimulation) in a biological specimen. A relative measurement (ratio or percentage) of the precursor (blast stage) plasma cells (antibody secreting cells derived from B cells via antigen stimulation) to all lymphocytes in a biological specimen. A measurement of the pregnancy-associated plasma protein-A in a biological specimen.

NCI Preferred Term Plasmacytoid Lymphocyte to Lymphocyte Ratio Measurement

C82030

Plasminogen Activator Inhibitor-1 Plasminogen Activator Inhibitor-1 AG Plasmodium

Plasminogen Activator Inhibitor-1 Plasminogen Activator Inhibitor-1 AG Plasmodium

Plasminogen Activator Inhibitor-1 Measurement Plasminogen Activator Inhibitor-1 Antigen Measurement Plasmodium Measurement

C81989

C100453

C96624 C81962

Platelet Clumps Platelet Distribution Width

Platelet Clumps; PLT Clumps Platelet Distribution Width Platelet Hematocrit; Thrombocytocrit Platelets Poikilocytes Poikilocytes/ Erythrocytes Polychromasia Potassium Potassium/ Creatinine Prealbumin Precursor Plasma Cells; Plasmablast Precursor Plasma Cells/ Lymphocytes Pregnancy-Assoc iated Plasma Protein-A

Platelet Clumps Count Platelet Distribution Width

C100424

Platelet Hematocrit

Platelet Hematocrit Measurement

C51951 C79602 C74649

Platelets Poikilocytes Poikilocytes/Erythrocytes

Platelet Count Poikilocyte Measurement Poikilocyte to Erythrocyte Ratio Measurement Polychromasia Potassium Measurement Potassium to Creatinine Ratio Measurement Prealbumin Measurement Precursor Plasma Cell Count

C64803 C64853 C79462 C100435 C74619

Polychromasia Potassium Potassium/Creatinine Prealbumin Precursor Plasma Cells

C74650

Precursor Plasma Cells/Lymphocytes

Precursor Plasma Cell to Lymphocyte Ratio Measurement

C82031

Pregnancy-Associated Plasma Protein-A

Pregnancy-Associated Plasma Protein-A Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 152 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym ProB-type Natriuretic Peptide; proBNP; Pro-Brain Natriuretic Peptide Procollagen 1 N-Terminal Propeptide; Amino-terminal propeptide of type 1 procollagen; P1NP Aminoterm Type 1 Procollagen Type I Carboxy Term Peptide Proerythroblast Progesterone Proinsulin Prolactin Prolymphocytes Prolymphocytes/ Leukocytes Prolymphocytes/ Lymphocytes Promonocytes Promonocytes/ Leukocytes Promyelocytes Promyelocytes/ Leukocytes Promyelocytes/ Total Cells

NCI Code C82032

CDISC Submission Value ProB-type Natriuretic Peptide

CDISC Definition A measurement of the proB-type natriuretic peptide in a biological specimen.

NCI Preferred Term ProB-Type Natriuretic Peptide Measurement

C96625

Procollagen 1 N-Terminal Propeptide

A measurement of the procollagen 1 N-terminal propeptide in a biological specimen.

Procollagen 1 N-Terminal Propeptide Measurement

C82033

Procollagen Type I Carboxy Term Peptide Proerythroblast Progesterone Proinsulin Prolactin Prolymphocytes Prolymphocytes/Leukocytes

A measurement of the procollagen-1 carboxy-terminal peptide in a biological specimen. A measurement of the proerythroblasts in a biological specimen. A measurement of the progesterone hormone in a biological specimen. A measurement of the proinsulin in a biological specimen. A measurement of the prolactin hormone in a biological specimen. A measurement of the prolymphocytes in a biological specimen. A relative measurement (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the prolymphocytes to all lymphocytes in a biological specimen. A measurement of the promonocytes in a biological specimen. A relative measurement (ratio or percentage) of the promonocytes to all leukocytes in a biological specimen. A measurement of the promyelocytes (immature myelocytes) in a biological specimen. A relative measurement (ratio or percentage) of the promyelocytes (immature myelocytes) to all leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the promyelocytes (immature myelocytes) to total cells in a biological specimen (for example a bone marrow specimen).

Procollagen Type I Carboxy Terminal Peptide Measurement Proerythroblast Measurement Progesterone Measurement Proinsulin Measurement Prolactin Measurement Prolymphocyte Count Prolymphocyte To Leukocyte Ratio

C100446 C74791 C81967 C74870 C74620 C64829

C74651

Prolymphocytes/Lymphocytes

Prolymphocyte to Lymphocyte Ratio Measurement Promonocyte Count Promonocyte to Lymphocyte Ratio Measurement Promyelocyte Count Promyelocyte to Lymphocyte Ratio Measurement Promyelocyte to Total Cell Ratio Measurement

C74621 C74652

Promonocytes Promonocytes/Leukocytes

C74622 C74653

Promyelocytes Promyelocytes/Leukocytes

C98773

Promyelocytes/Total Cells

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Pronormoblasts/ Total Cells Propoxyphene Prostate Specific Antigen Prostatic Acid Phosphatase Protein

NCI Code C98870

CDISC Submission Value Pronormoblasts/Total Cells

CDISC Definition A relative measurement (ratio or percentage) of the pronormoblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the propoxyphene present in a biological specimen. A measurement of the prostate specific antigen in a biological specimen. A measurement of the prostatic acid phosphatase in a biological specimen. A measurement of a group of complex organic macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. A measurement of the protein S in a biological specimen. A relative measurement (ratio or percentage) of the protein to creatinine in a biological specimen. A relative measurement (ratio or percentage) of total proteins to the osmolality of a biological specimen.

NCI Preferred Term Pronormoblast to Total CellRatio Measurement Propoxyphene Measurement Prostate Specific Antigen Measurement Prostatic Acid Phosphatase Measurement Total Protein Measurement

C74885 C17634 C80204 C64858

Propoxyphene Prostate Specific Antigen Prostatic Acid Phosphatase Protein

C100436 C79463 C92240

Protein S Protein/Creatinine Protein/Osmolality

Protein S Protein/ Creatinine Protein/ Osmolality; Protein/ Osmolality Ratio Prothrombin Activity Prothrombin Fragments 1 + 2 Prothrombin Intl. Normalized Ratio

Protein S Measurement Protein to Creatinine Ratio Measurement Protein to Osmolality Ratio Measurement

C98774 C82034 C64805

Prothrombin Activity Prothrombin Fragments 1 + 2 Prothrombin Intl. Normalized Ratio

A measurement of the biological activity of prothrombin in a biological specimen. A measurement of the prothrombin fragments 1 and 2 in a biological specimen. A ratio that represents the prothrombin time for a plasma specimen, divided by the result for a control plasma specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test. A blood clotting measurement that evaluates the extrinsic pathway of coagulation. A measurement of the pseudoephedrine present in a biological specimen. A measurement of the pyridinoline in a biological specimen. A measurement of the red blood cell casts present in a biological specimen. A measurement of the antibodies produced by cellular damage caused by Treponema pallidum (syphilis) in a biological specimen. A measurement of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) in a biological specimen. A relative measurement (ratio or percentage) of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) to all lymphocytes in a biological specimen.

Prothrombin Activity Measurement Prothrombin Fragments 1 and 2 Measurement International Normalized Ratio of Prothrombin Time

C62656 C74696 C80211 C74772 C74716

Prothrombin Time Pseudoephedrine Pyridinoline RBC Casts Rapid Plasma Reagin

Prothrombin Time Pseudoephedrine Pyridinoline RBC Casts Rapid Plasma Reagin Reactive Lymphocytes Reactive Lymphocytes/ Lymphocytes

Prothrombin Time Pseudoephedrine Measurement Pyridinoline Measurement Red Blood Cell Cast Measurement Rapid Plasma Reagin Measurement

C74629

Reactive Lymphocytes

Reactive Lymphocyte Count Measurement Reactive Lymphocyte to Lymphocyte Ratio Measurement

C74654

Reactive Lymphocytes/Lymphocytes

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Reg upon Act Normal T-cell Exprd Secrtd; Chemokine Ligand 5 Renin; Angiotensinogen ase Reptilase Time Resistin Reticulocyte Hemoglobin Reticulocytes Reticulocytes/ Erythrocytes Retinol Binding Protein Rheumatoid Factor Riboflavin; Vitamin B2 Ribonucleoprote in Antibody; RNP Antibody Ringed Sideroblasts

NCI Code C81957

CDISC Submission Value Reg upon Act Normal T-cell Exprd Secrtd

CDISC Definition A measurement of the RANTES (regulated on activation, normally, T-cell expressed, and secreted) chemokine in a biological specimen.

NCI Preferred Term Reg upon Act Normal T-cell Exprd Secrtd Measurement

C74893

Renin

A measurement of the renin in a biological specimen.

Renin Measurement

C96628 C80205 C98776 C51947 C64828 C100437 C74717 C74898 C100457

Reptilase Time Resistin Reticulocyte Hemoglobin Reticulocytes Reticulocytes/Erythrocytes Retinol Binding Protein Rheumatoid Factor Riboflavin Ribonucleoprotein Antibody

A measurement of the time it takes a plasma sample to clot after adding the active enzyme reptilase. A measurement of the resistin in a biological specimen. A measurement of the amount of hemoglobin in reticulocytes. A measurement of the reticulocytes in a biological specimen. A relative measurement (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. A measurement of the total retinol binding protein in a biological specimen. A measurement of the rheumatoid factor antibody in a biological specimen. A measurement of the riboflavin in a biological specimen. A measurement of the ribonucleoprotein antibody in a biological specimen. A measurement of the ringed sideroblasts (abnormal nucleated erythroblasts with a large number of iron deposits in the perinuclear mitochondria, forming a ring around the nucleus) in a biological specimen. A measurement of the number of stacking red blood cells within a biological specimen. A measurement of the round epithelial cells present in a biological specimen. A measurement of the schistocytes (fragmented red blood cells) in a biological specimen. A measurement of the Scl-70 antibody in a biological specimen. A measurement of the secretin hormone in a biological specimen. A measurement of the serotonin hormone in a biological specimen.

Reptilase Time Measurement Resistin Measurement Reticulocyte Hemoglobin Measurement Reticulocyte Count Reticulocyte To Erythrocyte Ratio Retinol Binding Protein Measurement Rheumatoid Factor Measurement Vitamin B2 Measurement Ribonucleoprotein Antibody Measurement Ringed Sideroblast Measurement

C100419

Ringed Sideroblasts

C74624 C74698 C74706 C100458

Rouleaux Formation Round Epithelial Cells Schistocytes Scl-70 Antibody

Rouleaux Formation Round Epithelial Cells Schistocytes Scl-70 Antibody; Scleroderma-70 Antibody Secretin Serotonin

Rouleaux Formation Count Round Epithelial Cell Count Schistocyte Count Scl-70 Antibody Measurement

C74871 C74872

Secretin Serotonin

Secretin Measurement Serotonin Measurement

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Sex Hormone Binding Globulin; Sex Hormone Binding Protein Sezary Cells

NCI Code C74745

CDISC Submission Value Sex Hormone Binding Globulin

CDISC Definition A measurement of the sex hormone binding (globulin) protein in a biological specimen.

NCI Preferred Term Sex Hormone Binding Protein Measurement

C74625

Sezary Cells

A measurement of the Sezary cells (atypical lymphocytes with cerebriform nuclei) in a biological specimen. A relative measurement (ratio or percentage of the Sezary cells (atypical lymphocytes with cerebriform nuclei) to all lymphocytes in a biological specimen. A measurement of the sickle cells (sickle shaped red blood cells) in a biological specimen. A relative measurement (ratio or percentage) of the sickle cells (sickle shaped red blood cells) to all erythrocytes in a biological specimen. A measurement of the sideroblasts (nucleated erythroblasts with iron granules in the cytoplasm) in a biological specimen. A measurement of the Sjogrens SS-A antibody in a biological specimen. A measurement of the Sjogrens SS-B antibody in a biological specimen. A measurement of the Smith antibody in a biological specimen. A measurement of the smudge cells (the nuclear remnant of a ruptured white blood cell) in a biological specimen. A measurement of the sodium in a biological specimen. A relative measurement (ratio or percentage) of the sodium to creatinine in a biological specimen. A measurement of the soluble interleukin 2 receptor activity in a biological specimen.

Sezary Cell Count

C74655

Sezary Cells/Lymphocytes

Sezary Cells/ Lymphocytes Sickle Cells Sickle Cells/ Erythrocytes Sideroblast

Sezary Cell to Lymphocyte Ratio Measurement Sickle Cell Count Sickle Cell to Erythrocyte Ratio Measurement Sideroblast Measurement

C74626 C74656

Sickle Cells Sickle Cells/Erythrocytes

C100418

Sideroblast

C92236

Sjogrens SS-A Antibody

Ro Antibody; Sjogrens SS-A Antibody La Antibody; Sjogrens SS-B Antibody Smith Antibody Smudge Cells; Basket Cells Sodium Sodium/ Creatinine Soluble Interleukin 2 Receptor Activity Soluble Transferrin Receptor Soluble Vascular Cell Adhesion Molecule 1 Somatotrophin; Growth Hormone

Sjogren's SS-A Antibody Measurement Sjogren's SS-B Antibody Measurement Smith Antibody Measurement Smudge Cell Count

C92237

Sjogrens SS-B Antibody

C92281 C74627

Smith Antibody Smudge Cells

C64809 C79464 C102280

Sodium Sodium/Creatinine Soluble Interleukin 2 Receptor Activity

Sodium Measurement Sodium to Creatinine Ratio Measurement Soluble Interleukin 2 Receptor Activity Measurement

C100438

Soluble Transferrin Receptor

A measurement of the soluble transferrin receptor in a biological specimen. A measurement of the soluble vascular cell adhesion molecule 1 in a biological specimen. A measurement of the somatotrophin (growth) hormone in a biological specimen.

Soluble Transferrin Receptor Measurement Soluble Vascular Cell Adhesion Molecule 1 Somatotropin Measurement

C92533

Soluble Vasc Cell Adhesion Molecule 1 Somatotrophin

C80360

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Sorbitol Dehydrogenase Specific Gravity Specimen Appearance Sperm Motility Spermatozoa Spherocytes

NCI Code C79465 C64832 C25377 C102281 C74663 C74707

CDISC Submission Value Sorbitol Dehydrogenase Specific Gravity Specimen Appearance Sperm Motility Spermatozoa Spherocytes

CDISC Definition A measurement of the sorbitol dehydrogenase in a biological specimen. A ratio of the density of a fluid to the density of water. The outward or visible aspect of a specimen. A measurement of the sperm capable of forward, progressive movement in a semen specimen. A measurement of the spermatozoa cells present in a biological specimen. A measurement of the spherocytes (small, sphere-shaped red blood cells) in a biological specimen. A measurement of the squamous epithelial cells present in a biological specimen. A measurement of the squamous transitional epithelial cells present in a biological specimen.

NCI Preferred Term Sorbitol Dehydrogenase Measurement Specific Gravity Appearance Sperm Motility Measurement Spermatozoa Cell Count Spherocyte Count

C74773 C74774

Squamous Epithelial Cells Squamous Transitional Epithelial Cells

Squamous Epithelial Cells Squamous Transitional Epithelial Cells; Epithelial Cells Starch Crystals Stem Cell Factor; KIT Ligand Stomatocytes

Squamous Epithelial Cell Count Squamous Transitional Epithelial Cell Count

C81951 C82035

Starch Crystals Stem Cell Factor

A measurement of the starch crystals in a biological specimen. A measurement of the stem cell factor in a biological specimen. A measurement of the stomatocytes (red blood cells with an oval or rectangular area of central pallor, producing the appearance of a cell mouth) in a biological specimen. A measurement of Streptolysin O Antibody in a biological specimen.

Starch Crystal Measurement Stem Cell Factor Measurement

C74708

Stomatocytes

Stomatocyte Count

C92282

Streptolysin O Antibody

Streptolysin O Antibody; Antistreptolysin O Sulfa Crystals Leptocytes; Target Cells; Codocytes; Mexican Hat Cells Tau Protein; Total Tau Protein Testosterone; Total Testosterone Testosterone, Free Thiamine; Vitamin B1

Streptolysin O Antibody Measurement

C74755 C96636

Sulfa Crystals Target Cells

A measurement of the sulfa crystals present in a biological specimen. A measurement of the target cells in a biological specimen.

Sulfa Crystal Measurement Target Cell Count

C84810 C74793

Tau Protein Testosterone

A measurement of the total Tau protein in a biological specimen. A measurement of the total (free and bound) testosterone in a biological specimen. A measurement of the free testosterone in a biological specimen. A measurement of the thiamine in a biological specimen.

Tau Protein Measurement Total Testosterone Measurement

C74785 C74896

Testosterone, Free Thiamine

Free Testosterone Measurement Vitamin B1 Measurement

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Thrombin Time Thrombopoietin Thyroid Antibodies Thyroid Antimicrosomal Antibodies Thyroid Antithyroglobuli n Antibodies Thyroperoxidase; Thyroid Peroxidase Thyroperoxidase Antibody Thyrotropin Thyrotropin Releasing Hormone; Thyrotropin Releasing Factor Thyroxine; Total T4 Thyroxine Binding Globulin Thyroxine, Free; Free T4 Tissue Inhibitor of Metalloproteinas e1 Tissue Plasminogen Activator Antigen Total Iron Binding Capacity

NCI Code C80365 C74873 C81990 C81991

CDISC Submission Value Thrombin Time Thrombopoietin Thyroid Antibodies Thyroid Antimicrosomal Antibodies Thyroid Antithyroglobulin Antibodies Thyroperoxidase

CDISC Definition A measurement of the time it takes a plasma sample to clot after adding the active enzyme thrombin. (NCI) A measurement of the thrombopoietin hormone in a biological specimen. A measurement of the thyroid antibodies in a biological specimen. A measurement of the thyroid antimicrosomal antibodies in a biological specimen. A measurement of the thyroid antithyroglobulin antibodies in a biological specimen. A measurement of the thyroperoxidase in a biological specimen. A measurement of the thyroperoxidase antibody in a biological specimen. A measurement of the thyrotropin in a biological specimen. A measurement of the thyrotropin releasing hormone in a biological specimen.

NCI Preferred Term Thrombin Time Thrombopoietin Measurement Thyroid Antibody Measurement Thyroid Antimicrosomal Antibody Measurement Thyroid Antithyroglobulin Antibody Measurement Thyroperoxidase Measurement

C81992

C96639

C96638 C64813 C74874

Thyroperoxidase Antibody Thyrotropin Thyrotropin Releasing Hormone

Thyroperoxidase Antibody Measurement Thyrotropin Measurement Thyrotropin Releasing Hormone Measurement

C74794 C74746 C74786 C82036

Thyroxine Thyroxine Binding Globulin Thyroxine, Free Tissue Inhibitor of Metalloproteinase 1

A measurement of the total (free and bound) thyroxine in a biological specimen. A measurement of the thyroxine binding globulin protein in a biological specimen. A measurement of the free thyroxine in a biological specimen. A measurement of the tissue inhibitor of metalloproteinase 1 in a biological specimen.

Total Thyroxine Measurement Thyroxine Binding Globulin Protein Measurement Free Thyroxine Measurement Tissue Inhibitor of Metalloproteinase 1 Measurement

C81993

Tissue Plasminogen Activator Antigen

A measurement of the tissue plasminogen activator antigen in a biological specimen.

Tissue Plasminogen Activator Antigen Measurement

C74718 C80208

Total Iron Binding Capacity

A measurement of the amount of iron needed to fully saturate the transferrin in a biological specimen. A measurement of the ability of the antioxidants in a biological specimen to buffer free radicals in a suspension. A measurement of the toxic granulation in neutrophilic blood cells. A measurement of the transferrin in a biological specimen.

Total Iron Binding Capacity Total Radical-Trap Antioxidant Potential Measurement

Total Radical-Trap Antioxidant Total Potential Radical-Trap Antioxidant Potential Toxic Granulation Transferrin Toxic Granulation Transferrin

C96641 C82037

Toxic Granulation Measurement Transferrin Measurement

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Saturation C92251 Transitional Epithelial CellsTransitional Epithelial Cells Lipase C92238 A measurement of the iron bound to transferrin in a biological specimen. A measurement of the transitional epithelial cells present in a biological specimen. A measurement of the pancreatic lipase in a biological specimen. Transferrin Saturation Measurement Transitional Epithelial Cells Measurement Triacylglycerol Lipase Measurement Trichomonas Screening

NCI CodeCDISC Submission Value C98792 Transferrin SaturationTransferrin

C64807Triacylglycerol LipaseTriacylglycerol

TrichomonasTrichomonasExamination of a biological specimen to detect the presence of any protozoan belonging to the Trichomonas genus. Antidepressants A measurement of tricyclic antidepressants in a biological specimen.

C100420Tricyclic AntidepressantsTricyclic

Tricyclic Antidepressant Measurement Triglyceride Measurement Triiodothyronine Measurement Triiodothyronine Uptake Measurement Free Triiodothyronine Measurement Reverse Triiodothyronine Measurement Triple Phosphate Crystal Measurement Troponin I Measurement Troponin T Measurement Tryptase Measurement Tubular Epithelial Cell Count

C64812TriglyceridesTriglyceridesA measurement of the triglycerides in a biological specimen. C74747 C74748 TriiodothyronineTriiodothyronine ; Total T3 Triiodothyronine UptakeTriiodothyronine Uptake Triiodothyronine, FreeTriiodothyronine , Free; Free T3 Triiodothyronine, ReverseTriiodothyronine , Reverse A measurement of the total (free and bound) triiodothyronine in a biological specimen. A measurement of the binding of triiodothyonine to thyroxine binding globulin protein in a biological specimen. A measurement of the free triiodothyronine in a biological specimen. A measurement of the reverse triiodothyronine in a biological specimen. A measurement of the triple phosphate crystals present in a biological specimen.

C74787 C81968

C74756Triple Phosphate CrystalsTriple Phosphate Crystals

C74749Troponin ITroponin IA measurement of the actin binding troponin in a biological specimen. C74750 C92292 C74775 Troponin TTroponin TA measurement of the tropomyosin binding troponin in a biological specimen. TryptaseTryptaseA measurement of the tryptase in a biological specimen. Tubular Epithelial CellsTubular Epithelial Cells; Renal Tubular Epithelial Cells C74751 Tumor Necrosis FactorTumor Necrosis Factor; Tumor Necrosis Factor alpha A measurement of the tubular epithelial cells present in a biological specimen.

A measurement of the total tumor necrosis factor (cachexin) cytokine in a biological specimen.

Tumor Necrosis Factor Measurement

C74723TurbidityTurbidityA measurement of the opacity of a biological specimen. C82038 Type I Collagen C-Telopeptides Type I Collagen C-Telopeptides; Type I Collagen X-linked C-telopeptide Type I Collagen N-Telopeptides A measurement of the type I collagen C-telopeptides in a biological specimen.

Turbidity Measurement Type I Collagen C-Telopeptide Measurement

C82039

Type I Collagen N-Telopeptides

A measurement of the type I collagen N-telopeptides in a biological specimen.

Type I Collagen N-Telopeptide Measurement

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Type I Myeloblasts Type II Collagen C-Telopeptides Type II Collagen N-Telopeptides Type II Myeloblasts Type III Myeloblasts Tyrosine Crystals Unclassified Casts Unclassified Crystals Unsaturated Iron Binding Capacity Urate; Uric Acid Urea Urea/Creatinine Uric Acid Crystals Urine Conductivity Urobilinogen VLDL Cholesterol Vacuolated Neutrophils Vanillyl Mandelic Acid; Vanilmandelic Acid Varicella Zoster Virus IgA Antibody Varicella Zoster Virus IgG Antibody

NCI Code C92283 C82040 C82041 C92284 C92285 C74683 C74776 C74757 C74719 C64814 C64815 C96645 C74684 C102282

CDISC Submission Value Type I Myeloblasts Type II Collagen C-Telopeptides Type II Collagen N-Telopeptides Type II Myeloblasts Type III Myeloblasts Tyrosine Crystals Unclassified Casts Unclassified Crystals Unsaturated Iron Binding Capacity Urate Urea Urea/Creatinine Uric Acid Crystals Urine Conductivity

CDISC Definition A measurement of type I myeloblast cells per unit of a biological specimen. A measurement of the type II collagen C-telopeptides in a biological specimen. A measurement of the type II collagen N-telopeptides in a biological specimen. A measurement of type II myeloblast cells per unit of a biological specimen. A measurement of type III myeloblast cells per unit of a biological specimen. A measurement of the triple phosphate crystals present in a biological specimen. A measurement of the unclassifiable casts present in a biological specimen. A measurement of the unclassifiable crystals present in a biological specimen. A measurement of the binding capacity of unsaturated iron in a biological specimen. A measurement of the urate in a biological specimen. A measurement of the urea in a biological specimen. A relative measurement (ratio or percentage) of the urea to creatinine in a biological specimen. A measurement of the uric acid crystals present in a biological specimen. A measurement of the urine conductivity which is a non-linear function of the electrolyte concentration in the urine. A measurement of the urobilinogen in a biological specimen. A measurement of the very low density lipoprotein cholesterol in a biological specimen. A measurement of the neutrophils containing small vacuoles in a biological specimen. A measurement of the vanillyl mandelic acid metabolite in a biological specimen.

NCI Preferred Term Type I Myeloblasts Measurement Type II Collagen C-Telopeptide Measurement Type II Collagen N-Telopeptide Measurement Type II Myeloblasts Measurement Type III Myeloblasts Measurement Tyrosine Crystal Measurement Unclassified Cast Measurement Unclassified Crystal Measurement Unsaturated Iron Binding Capacity Measurement Urate Measurement Urea Measurement Urea to Creatinine Ratio Measurement Uric Acid Crystal Measurement Urine Conductivity

C64816 C64806 C74628 C74875

Urobilinogen VLDL Cholesterol Vacuolated Neutrophils Vanillyl Mandelic Acid

Urobilinogen Measurement Serum VLDL Cholesterol Measurement Vacuolated Neutrophil Count Vanillyl Mandelic Acid Measurement

C98795

Varicella Zoster Virus IgA Antibody Varicella Zoster Virus IgG Antibody

A measurement of the Varicella Zoster virus IgA antibodies in a biological specimen. A measurement of the Varicella Zoster virus IgG antibodies in a biological specimen.

Varicella Zoster Virus IgA Antibody Measurement Varicella Zoster Virus IgG Antibody Measurement

C98796

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC Synonym Varicella Zoster Virus IgM Antibody Vascular Cell Adhesion Molecule 1 Vascular Endothelial Growth Factor Viscosity Vitamin A; Retinol Vitamin B12 Vitamin B17; Amygdalin Vitamin B5; Pantothenic Acid Vitamin B6; Pyridoxine Vitamin B7; Biotin Folic Acid; Vitamin B9 Vitamin C; Ascorbic Acid Vitamin D; Total Vitamin D Vitamin D2; Ergocalciferol Vitamin D3; Cholecalciferol Vitamin E; Tocopherol Vitamin K; Naphthoquinone Volume WBC Casts Waxy Casts Yeast Cells

NCI Code C98797

CDISC Submission Value Varicella Zoster Virus IgM Antibody Vascular Cell Adhesion Molecule 1 Vascular Endothelial Growth Factor Viscosity Vitamin A Vitamin B12 Vitamin B17 Vitamin B5 Vitamin B6 Vitamin B7 Vitamin B9 Vitamin C Vitamin D Vitamin D2 Vitamin D3 Vitamin E Vitamin K Volume WBC Casts Waxy Casts Yeast Cells

CDISC Definition A measurement of the Varicella Zoster virus IgM antibodies in a biological specimen. A measurement of the vascular cell adhesion molecule 1 in a biological specimen. A measurement of the vascular endothelial growth factor in a biological specimen. The resistance of a liquid to sheer forces and flow. (NCI) A measurement of the Vitamin A in a biological specimen. A measurement of the Vitamin B12 in a serum specimen. A measurement of the Vitamin B17 in a biological specimen. A measurement of the Vitamin B5 in a biological specimen. A measurement of the Vitamin B6 in a biological specimen. A measurement of the Vitamin B7 in a biological specimen. A measurement of the folic acid in a biological specimen. A measurement of the Vitamin C in a biological specimen. A measurement of the total Vitamin D in a biological specimen. A measurement of the Vitamin D2 in a biological specimen. A measurement of the Vitamin D3 in a biological specimen. A measurement of the Vitamin E in a biological specimen. A measurement of the Vitamin K in a biological specimen. A measurement of the volume of a biological specimen. A measurement of the white blood cell casts present in a biological specimen. A measurement of the waxy casts present in a biological specimen. A measurement of the yeast cells present in a biological specimen.

NCI Preferred Term Varicella Zoster Virus IgM Antibody Measurement Vascular Cell Adhesion Molecule 1 Measurement Vascular Endohelial Growth Factor Measurement Viscosity Vitamin A Measurement Vitamin B12 Measurement Vitamin B17 Measurement Vitamin B5 Measurement Vitamin B6 Measurement Vitamin B7 Measurement Folic Acid Measurement Vitamin C Measurement Vitamin D Measurement Vitamin D2 Measurement Vitamin D3 Measurement Vitamin E Measurement Vitamin K Measurement Volume Measurement White Blood Cell Cast Measurement Waxy Cell Cast Measurement Yeast Cell Measurement

C82042

C92514

C75912 C74895 C64817 C74897 C74900 C74901 C74902 C74676 C74903 C84818 C74904 C74905 C74906 C74907 C74720 C74778 C74777 C74664

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CDISC SDTM Controlled Terminology, 2012-06-29


C67154 - LBTEST - Laboratory Test Name Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Yeast Hyphae Screening

NCI CodeCDISC Submission Value C92239

Yeast HyphaeYeast HyphaeExamination of a biological specimen to detect the presence of any yeast cells that are in the long, filamentous and branching phase of growth.

C80210ZincZincA measurement of the zinc in a biological specimen.Zinc Measurement C45997 C98799 pHpHA measure of the acidity or alkalinity of a fluid on a scale of 0 to 14. von Willebrand Factorvon Willebrand Factor; von Willebrand Factor Antigen A measurement of the von Willebrand factor in a biological specimen. pH

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CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Glycoprotein C80167A1ANTRYPAlpha-1 Antitrypsin; Serum Trypsin Inhibitor C100462 A1MCREATAlpha-1 Microglobulin/ Creatinine C100461A1MICGAlpha-1 Microglobulin; Protein HC C80168A2MACGAlpha-2 Macroglobulin C100430AAPAlanine Aminopeptidase A measurement of the alpha-1 acid glycoprotein in a biological specimen. A measurement of the alpha-1 antitrypsin in a biological specimen. Alpha-1 Acid Glycoprotein Measurement Alpha-1 Antitrypsin Measurement

NCI CodeCDISC Submission Value C100429 A1AGLPAlpha-1 Acid

A relative measurement (ratio or percentage) of the alpha-1 microglobulin to creatinine in a biological specimen. A measurement of the alpha-1 microglobulin in a biological specimen. A measurement of the alpha-2 macroglobulin in a biological specimen. A measurement of the alanine aminopeptidase in a biological specimen.

Alpha-1 Microglobulin to Creatinine Ratio Measurement Alpha-1 Microglobulin Measurement

Alpha-2 Macroglobulin Measurement Alanine Aminopeptidase Measurement Acanthocyte Count Acanthocyte to Erythrocyte Ratio Measurement Angiotensin Converting Enzyme Measurement Acetoacetic Acid Measurement

C74699ACANTAcanthocytesA measurement of the acanthocytes in a biological specimen. C74633 ACANTRBCAcanthocytes/ Erythrocytes C80169 ACEAngiotensin Converting Enzyme C92247 ACETOACAcetoacetic Acid; Acetoacetate A relative measurement (ratio or percentage) of acanthocytes to all erythrocytes in a biological specimen. A measurement of the angiotensin converting enzyme in a biological specimen. A measurement of the acetoacetic acid in a biological specimen.

C74838ACHAcetylcholineA measurement of the acetylcholine hormone in a biological specimen. C96560 C96559 ACHEAcetylcholineste rase ACHRABAcetylcholine Receptor Antibody C80163 C74780 ACPHOSAcid Phosphatase ACTHAdrenocorticotr opic Hormone C92286ACYLCAOXAcyl Coenzyme A Oxidase; Fatty Acyl Coenzyme A Oxidase; Acyl CoA Oxidase C74847 ADHAntidiuretic Hormone; Vasopressin C102257ADPAdenosine Diphosphate A measurement of the acetylcholinesterase in a biological specimen. A measurement of the acetylcholine receptor antibody in a biological specimen. A measurement of the acid phosphatase in a biological specimen. A measurement of the adrenocorticotropic hormone in a biological specimen. A measurement of the acyl coenzyme A oxidase in a biological specimen.

Acetylcholine Measurement Acetylcholinesterase Measurement Acetylcholine Receptor Antibody Measurement Acid Phosphatase Measurement Adrenocorticotropic Hormone Measurement Acyl Coenzyme A Oxidase Measurement

A measurement of the antidiuretic hormone in a biological specimen. A measurement of the adenosine diphosphate in a biological specimen.

Antidiuretic Hormone Measurement

Adenosine Diphosphate Measurement

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CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Adiponectin Anti-Double Stranded DNA ADV Viral Load Anti-Factor Xa Activity

NCI Code C74839 C74913 C98705 C98706

CDISC Submission Value ADPNCTN ADSDNA ADVVLD AFACTXAA

CDISC Definition A measurement of the adiponectin hormone in a biological specimen. A measurement of the anti-double stranded DNA antibody in a biological specimen. A measurement of the adenovirus viral load in a biological specimen. A measurement of the anti-activated Factor X in a biological specimen. This test is used to monitor low molecular weight or unfractionated heparin levels in a biological specimen. A measurement of the alpha fetoprotein in a biological specimen. A measurement of the alpha fetoprotein L1 in a biological specimen. A measurement of the alpha fetoprotein L2 in a biological specimen. A measurement of the alpha fetoprotein L3 in a biological specimen. A relative measurement (ratio or percentage) of alpha fetoprotein L3 to total alpha fetoprotein in a biological specimen. A measurement of the albumin protein in a biological specimen. A relative measurement (ratio or percentage) of the albumin to the creatinine in a biological specimen.

NCI Preferred Term Adiponectin Measurement Anti-Double Stranded DNA Measurement Adenovirus Viral Load Measurement Anti-Factor Xa Activity Measurement

C74732 C96562 C96563 C96564 C96565

AFP AFPL1 AFPL2 AFPL3 AFPL3AFP

Alpha Fetoprotein Alpha Fetoprotein L1 Alpha Fetoprotein L2 Alpha Fetoprotein L3 A Fetoprotein L3/A Fetoprotein Albumin; Microalbumin Albumin/ Creatinine; Microalbumin/ Creatinine Ratio Albumin/ Globulin Aldolase Aldosterone Alkaline Phosphatase Bone Specific Alkaline Phosphatase Alkaline Phosphatase/ Creatinine Alanine Aminotransferas e; SGPT

Alpha-fetoprotein Measurement Alpha Fetoprotein L1 Measurement Alpha Fetoprotein L2 Measurement Alpha Fetoprotein L3 Measurement Alpha Fetoprotein L3 to Total Alpha Fetoprotein Ratio Measurement Albumin Measurement Albumin To Creatinine Protein Ratio Measurement

C64431 C74761

ALB ALBCREAT

C74894 C74731 C74841 C64432 C92287

ALBGLOB ALDOLASE ALDSTRN ALP ALPBS

The ratio of albumin to globulin in a biological specimen. A measurement of the aldolase enzyme in a biological specimen. A measurement of the aldosterone hormone in a biological specimen. A measurement of the alkaline phosphatase in a biological specimen. A measurement of the bone specific alkaline phosphatase isoform in a biological specimen. A relative measurement (ratio or percentage) of the alkaline phosphatase to creatinine in a biological specimen. A measurement of the alanine aminotransferase in a biological specimen.

Albumin to Globulin Ratio Measurement Aldolase Measurement Aldosterone Measurement Alkaline Phosphatase Measurement Bone Specific Alkaline Phosphatase Measurement Alkaline Phosphatase to Creatinine Ratio Measurement Alanine Aminotransferase Measurement

C79438

ALPCREAT

C64433

ALT

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 164 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Antimitochondri al Antibodies; Mitochondrial Antibody Ammonia; NH3 Amorphous Sediment; Amorphous Debris Amphetamine Dextroamphetam ine; d-amphetamine Amylase Amylase, Pancreatic Amylase, Salivary Amyloid Beta 42; Amyloid Beta 42 Protein Amyloid, Beta; Beta Amyloid Amyloid P Antinuclear Antibodies Androstenediol Androstenedione ; 4-Androstenedio ne Antiglobulin Test, Direct; Direct Coombs Test Angiotensin I Angiotensin II Angiotensinogen; Angiotensin Precursor

NCI Code C81975

CDISC Submission Value AMA

CDISC Definition A measurement of the antimitochondrial antibodies in a biological specimen.

NCI Preferred Term Antimitochondrial Antibody Measurement

C74799 C74666

AMMONIA AMORPHSD

A measurement of the ammonia in a biological specimen. A measurement of the amorphous sediment present in a biological specimen.

Ammonia Measurement Amorphous Sediment Measurement

C74687 C102262

AMPHET AMPHETD

A measurement of any amphetamine class drug present in a biological specimen. A measurement of the dextroamphetamine in a biological specimen. A measurement of the total enzyme amylase in a biological specimen. A measurement of the pancreatic enzyme amylase in a biological specimen. A measurement of the salivary enzyme amylase in a biological specimen. A measurement of the 42 amino acid amyloid beta protein isoform in a biological specimen. A measurement of the total amyloid beta in a biological specimen. A measurement of the total amyloid P in a biological specimen. A measurement of the antinuclear antibodies (antibodies that attack the body's own tissue) in a biological specimen. A measurement of the androstenediol metabolite in a biological specimen. A measurement of the androstenedione hormone in a biological specimen.

Amphetamine Drug Class Measurement Dextroamphetamine Measurement

C64434 C98767 C98780 C84809

AMYLASE AMYLASEP AMYLASES AMYLB42

Amylase Measurement Pancreatic Amylase Measurement Salivary Amylase Measurement Beta Amyloid 42 Measurement

C81999 C81998 C74916

AMYLOIDB AMYLOIDP ANA

Beta Amyloid Measurement Amyloid P Measurement Antinuclear Antibody Measurement

C74842 C74843

ANDSTNDL ANDSTNDN

Androstenediol Metabolite Measurement Androstenedione Measurement

C81974

ANGLOBDR

A measurement of the antibody or complement-coated erythrocytes in a biological specimen in vivo.

Direct Antiglobulin Test

C74844 C74845 C74846

ANGTNS1 ANGTNS2 ANGTNSGN

A measurement of the angiotensin I hormone in a biological specimen. A measurement of the angiotensin II hormone in a biological specimen. A measurement of the angiotensinogen hormone in a biological specimen.

Angiotensin I Measurement Angiotensin II Measurement Angiotensinogen Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 165 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Anion Gap

NCI Code C74685

CDISC Submission Value ANIONG

CDISC Definition A computed estimate of the unmeasured anions (those other than the chloride and bicarbonate anions) in a biological specimen. A measurement of the inequality in the size of the red blood cells in a whole blood specimen. A measurement of the atrial natriuretic peptide in a biological specimen. A measurement of the antithrombin activity in a biological specimen.

NCI Preferred Term Anion Gap Measurement

C74797 C74886

ANISO ANP

Anisocytes Atrial Natriuretic Peptide; Atriopeptin Antithrombin; Antithrombin III; Antithrombin Activity; Antithrombin III Activity Antithrombin Antigen; Antithrombin III Antigen Antidepressants Antiphospholipid Antibodies Apolipoprotein A1 Apolipoprotein AII Apolipoprotein B Apolipoprotein C2; Apolipoprotein CII Apolipoprotein CIII Apolipoprotein E Apolipoprotein E4 Apolipoprotein H Apolipoprotein J; Clusterin Specimen Appearance Lupus Anticoagulant Sensitive APTT; APPT-LA

Anisocyte Measurement Atrial Natriuretic Peptide Measurement Antithrombin Measurement

C81958

ANTHRM

C81977

ANTHRMAG

A measurement of the antithrombin antigen in a biological specimen.

Antithrombin Antigen Measurement

C74691 C102258 C74733 C82000 C74734 C100427

ANTIDPRS APLAB APOA1 APOA2 APOB APOC2

A measurement of any antidepressant class drug present in a biological specimen. A measurement of the antiphospholipid antibodies in a biological specimen. A measurement of the apolipoprotein A1 in the high density lipoproteins of a biological specimen. A measurement of the apolipoprotein AII in a biological specimen. A measurement of the apolipoprotein B in the low density lipoproteins of a biological specimen. A measurement of the apolipoprotein C2 in a biological specimen.

Antidepressant Measurement Antiphospholipid Antibody Measurement Apolipoprotein A1 Measurement Apolipoprotein AII Measurement Apolipoprotein B Measurement Apolipoprotein C2 Measurement

C82001 C82002 C92293 C82003 C100428 C25377 C102277

APOC3 APOE APOE4 APOH APOJ APPEAR APPTLAS

A measurement of the apolipoprotein CIII in a biological specimen. A measurement of the apolipoprotein E in a biological specimen. A measurement of the apolipoprotein E4 in a biological specimen. A measurement of the apolipoprotein H in a biological specimen. A measurement of the apolipoprotein J in a biological specimen. The outward or visible aspect of a specimen. A measurement of the length of time that it takes for clotting to occur when a lupus sensitive reagent is added to a plasma specimen.

Apolipoprotein CIII Measurement Apolipoprotein E Measurement Apolipoprotein E4 Measurement Apolipoprotein H Measurement Apolipoprotein J Measurement Appearance Lupus Anticoagulant Sensitive APTT Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 166 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Activated Protein C Resistance; Factor V Leiden Screen Activated Partial Thromboplastin Time Activated PTT/Standard PTT; Activated Partial Thromboplastin Time/Standard Thromboplastin Time Activated PTT/Standard Arachidonic Acid Anti-Saccharomy ces cerevisiae Antibody Anti-Single Stranded DNA IgG Aspartate Aminotransferas e; SGOT Aspartate Aminotransferas e Antigen; SGOT Antigen Auer Rods

NCI Code C100471

CDISC Submission Value APROTCRS

CDISC Definition A measurement of the resistance in the anticoagulation response to activated protein C in a biological specimen. A measurement of the length of time that it takes for clotting to occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. A relative measurement (ratio or percentage) of the subject's activated partial thromboplastin time to a standard or control partial thromboplastin time.

NCI Preferred Term Activated Protein C Resistance Measurement

C38462

APTT

Partial Thromboplastin Time

C100421

APTTSPTT

Activated PTT to Standard PTT Ratio Measurement

C98862

APTTSTND

A relative measurement (ratio or percentage) of the subject's partial thromboplastin time to a standard or control partial thromboplastin time. A measurement of the arachidonic acid present in a biological specimen. A measurement of the anti-Saccharomyces cerevisiae antibody in a biological specimen. A measurement of the anti-single stranded DNA IgG antibody in a biological specimen. A measurement of the aspartate aminotransferase in a biological specimen. A measurement of the aspartate aminotransferase antigen in a biological specimen.

Activated PTT/Standard Ratio Measurement Arachidonic Acid Measurement Anti-Saccharomyces cerevisiae Antibody Measurement Anti-Single Stranded DNA IgG Measurement Aspartate Aminotransferase Measurement Aspartate Aminotransferase Antigen Measurement

C102259 C81976

ARA ASCAB

C92269

ASSDNA

C64467

AST

C81978

ASTAG

C74657

AUERRODS

A measurement of the Auer rods (elongated needle structures that are found in the cytoplasm of leukemic blasts and are formed by clumps of azurophilic granular material) in a biological specimen. A measurement of the beta-2 glycoprotein antibody in a biological specimen. A measurement of the beta-2 microglobulin in a biological specimen. A measurement of the bacteria in a biological specimen. A measurement of any barbiturate class drug present in a biological specimen. A measurement of the basophils in a biological specimen.

Auer Rod Measurement

C81979

B2GLYAB

Beta-2 Glycoprotein Antibody Beta-2 Microglobulin Bacteria Barbiturates Basophils

Beta-2 Glycoprotein Antibody Measurement Beta-2 Microglobulin Measurement Bacterial Count Barbiturate Drug Class Measurement Total Basophil Count

C81980 C64469 C74688 C64470

B2MICG BACT BARB BASO

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 167 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Basophils/Total Cells Immature Basophils Immature Basophils/ Leukocytes Basophils/ Leukocytes Brain-Derived Neurotrophic Factor Beta Carotene; b-Carotene; Beta Carotin Beta-Hydroxybut yrate; B-Hydroxybutyra te; 3-Hydroxybutyra te Bicarbonate; HCO3 Direct Bilirubin Bile Acid; Bile Salts; Bile Acids; Bile Salt Bilirubin; Total Bilirubin Indirect Bilirubin Bite Cells

NCI Code C98865

CDISC Submission Value BASOCE

CDISC Definition A relative measurement (ratio or percentage) of the basophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the immature basophils in a biological specimen. A relative measurement (ratio or percentage) of immature basophils to total leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the basophils to leukocytes in a biological specimen. A measurement of the brain-derived neurotrophic factor in a biological specimen. A measurement of the beta carotene in a biological specimen. A measurement of the total Beta-hydroxybutyrate in a biological specimen.

NCI Preferred Term Basophil to Total CellRatio Measurement Immature Basophil Count Immature Basophil to Leukocyte Ratio Measurement Basophil To Leukocyte Ratio Brain-Derived Neurotrophic Factor Measurement Beta Carotene Measurement

C96670 C96671

BASOIM BASOIMLE

C64471 C82004

BASOLE BDNF

C100472

BETACRTN

C96568

BHYXBTR

Beta-Hydroxybutyrate Measurement

C74667 C64481 C74800

BICARB BILDIR BILEAC

A measurement of the bicarbonate in a biological specimen. A measurement of the conjugated or water-soluble bilirubin in a biological specimen. A measurement of the total bile acids in a biological specimen. A measurement of the total bilirubin in a biological specimen. A measurement of the unconjugated or non-water-soluble bilirubin in a biological specimen. A measurement of the bite cells (erythrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) in a biological specimen . A measurement of the BK virus viral load in a biological specimen. A measurement of the blast cells in a biological specimen. A relative measurement (ratio or percentage) of the blasts to leukocytes in a biological specimen. A measurement of the leukemic blasts (lymphoblasts that remain in an immature state even when outside the bone marrow) in a biological specimen.

Bicarbonate Measurement Direct Bilirubin Measurement Bile Acid Measurement

C38037 C64483 C74700

BILI BILIND BITECE

Total Bilirubin Measurement Indirect Bilirubin Measurement Bite Cell Count

C98710 C74605 C64487 C74630

BKVVLD BLAST BLASTLE BLASTLM

BKV Viral Load Blasts Blasts/ Leukocytes Leukemic Blasts; Leukemic Lymphoblasts; Immunoblastic Lymphocytes

BK Virus Viral Load Measurement Blast Count Blast To Leukocyte Ratio Leukemic Blast Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 168 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Leukemic Blasts/ Lymphocytes Lymphoblasts

NCI Code C74641

CDISC Submission Value BLSTLMLY

CDISC Definition A relative measurement (ratio or percentage) of the leukemic blasts (immature lymphoblasts) to mature lymphocytes in a biological specimen. A measurement of the lymphoblasts (immature cells that differentiate to form lymphocytes) in a biological specimen. A relative measurement (ratio or percentage) of the myeloblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the megakaryoblasts in a biological specimen. A relative measurement (ratio or percentage) of the megakaryoblasts to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the normoblasts to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the pronormoblasts to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the ringed sideroblasts (abnormal nucleated erythroblasts with a large number of iron deposits in the perinuclear mitochondria, forming a ring around the nucleus) in a biological specimen. A measurement of the sideroblasts (nucleated erythroblasts with iron granules in the cytoplasm) in a biological specimen. A measurement of the brain (B-type) natriuretic peptide in a biological specimen.

NCI Preferred Term Leukemic Blast to Lymphocyte Ratio Measurement Lymphoblast Count

C102278

BLSTLY

C98761

BLSTMBCE

Myeloblasts/ Total Cells Megakaryoblasts Megakaryoblasts /Total Cells Normoblasts/ Total Cells Pronormoblasts/ Total Cells Ringed Sideroblasts

Myeloblast to Total Cell Ratio Measurement Megakaryoblast Cell Count Megakaryoblast to Total Cell Ratio Measurement Normoblast to Total Cell Ratio Measurement Pronormoblast to Total CellRatio Measurement Ringed Sideroblast Measurement

C98752 C98753

BLSTMGK BLSTMKCE

C98764

BLSTNMCE

C98870

BLSTPNCE

C100419

BLSTRSID

C100418

BLSTSID

Sideroblast

Sideroblast Measurement

C74735

BNP

Brain Natriuretic Peptide; B-Type Natriuretic Peptide ProB-type Natriuretic Peptide; proBNP; Pro-Brain Natriuretic Peptide N-Terminal ProB-type Natriuretic Peptide; NT proBNP II; N-terminal pro-Brain Natriuretic Peptide Benzodiazepine

Brain Natriuretic Peptide Measurement

C82032

BNPPRO

A measurement of the proB-type natriuretic peptide in a biological specimen.

ProB-Type Natriuretic Peptide Measurement

C96610

BNPPRONT

A measurement of the N-terminal proB-type natriuretic peptide in a biological specimen.

N-Terminal ProB-type Natriuretic Peptide Measurement

C74692

BNZDZPN

A measurement of any benzodiazepine class drug present in a biological specimen.

Benzodiazepine Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 169 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Benzoylecgonine ; Cocaine Metabolite Bite Cells/ Erythrocytes Beta-Trace Protein Blood Urea Nitrogen BUN/Creatinine

NCI Code C75350

CDISC Submission Value BNZLCGN

CDISC Definition A measurement of the benzoylecgonine in a biological specimen. A relative measurement (ratio or percentage) of bite cells (erythrocytes with the appearance of a bite having been removed, due to oxidative hemolysis) to all erythrocytes in a biological specimen . A measurement of the beta-trace protein in a biological specimen. A measurement of the urea nitrogen in a blood specimen. A relative measurement (ratio or percentage) (ratio) of the blood urea nitrogen (BUN) to the creatinine in a biological specimen. A measurement of the Burr cells (erythrocytes characterized by the presence of small, blunt projections evenly distributed across the cell surface) in a biological specimen. A measurement of the complement C1q antibody in a biological specimen. A measurement of the complement C3 in a biological specimen. A measurement of the complement C3a in a biological specimen.

NCI Preferred Term Benzoylecgonine Measurement

C74634

BTECERBC

Bite Cell to Erythrocyte Ratio Measurement

C100426 C61019 C74753

BTP BUN BUNCREAT

Beta-Trace Protein Measurement Blood Urea Nitrogen Measurement Blood Urea Nitrogen To Creatinine Ratio Measurement Burr Cell Count

C74701

BURRCE

Burr Cells; Keratocytes

C80173 C80174 C80175

C1QAB C3 C3A

Complement C1q Antibody Complement C3 Complement C3a; ASP, Complement C3 DesArg, Acetylation-stim ulating Protein Complement C3b Complement C4 Complement C4a Complement C5a Calcium Cancer Antigen 125 Cancer Antigen 19-9 Cabot Rings

Complement C1q Antibody Measurement Complement C3 Measurement Complement C3a Measurement

C80176 C80177 C80178 C80179 C64488 C81981 C81982 C74702

C3B C4 C4A C5A CA CA125AG CA19_9AG CABOT

A measurement of the complement C3b in a biological specimen. A measurement of the complement C4 in a biological specimen. A measurement of the complement C4a in a biological specimen. A measurement of the complement C5a in a biological specimen. A measurement of the calcium in a biological specimen. A measurement of the cancer antigen 125 in a biological specimen. A measurement of the cancer antigen 19-9 in a biological specimen. A measurement of the Cabot rings (red-purple staining, threadlike, ring or figure 8 shaped filaments in an erythrocyte) in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of calcium by excretion of urine for a specified unit of time (e.g. one minute).

Complement C3b Measurement Complement C4 Measurement Complement C4a Measurement Complement C5a Measurement Calcium Measurement Cancer Antigen 125 Measurement Cancer Antigen 19-9 Measurement Cabot Ring Count

C96589

CACLR

Calcium Clearance

Calcium Clearance Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 170 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Calcium/ Creatinine Calcium, Ionized Calprotectin Cannabinoids Carboxyhemoglo bin Carnitine Carnitine Acetyl Transferase Carnitine, Free Casts Calcium Sulphate Complement Bb Cholecystokinin; Pancreozymin Cyclic Citrullinated Peptide Antibody CD19 CD19/ Lymphocytes CD3 CD34 CD3/ Lymphocytes CD4 CD40 CD40 Ligand CD4/CD8

NCI Code C79439 C81948 C82005 C74689 C96591 C74682 C92288 C74677 C74763 C96590 C80172 C74850 C96595

CDISC Submission Value CACREAT CAION CALPRO CANNAB CARBXHGB CARNIT CARNITAT CARNITF CASTS CASULPH CBB CCK CCPAB

CDISC Definition A relative measurement (ratio or percentage) of the calcium to creatinine in a biological specimen. A measurement of the ionized calcium in a biological specimen. A measurement of the calprotectin in a biological specimen. A measurement of any cannabinoid class drug present in a biological specimen. A measurement of the carboxyhemoglobin in a biological specimen. A measurement of the total carnitine in a biological specimen. A measurement of the carnitine acetyl transferase in a biological specimen. A measurement of the free carnitine in a biological specimen. A statement that indicates casts were looked for in a biological specimen. A measurement of the calcium sulphate in a biological specimen. A measurement of the complement Bb in a biological specimen. A measurement of the cholecystokinin hormone in a biological specimen. A measurement of the cyclic citrullinated peptide antibody in a biological specimen. A count of the CD19 B cells per unit of a biological specimen. A relative measurement (ratio or percentage) of CD19 B cells to all lymphocytes in a biological specimen. A count of the CD3 T cells per unit of a biological specimen. A measurement of the CD34 expressing cells per unit in a biological specimen. A relative measurement (ratio or percentage) of CD3 T cells to all lymphocytes in a biological specimen. A count of the CD4 T cells per unit of a biological specimen. A measurement of the CD40 in a biological specimen. A measurement of the CD40 ligand in a biological specimen. A relative measurement (ratio or percentage) of CD4 T cells to the CD8 T cells in a biological specimen.

NCI Preferred Term Calcium to Creatinine Ratio Measurement Ionized Calcium Measurement Calprotectin Measurement Cannabinoid Drug Class Measurement Carboxyhemoglobin Measurement Total Carnitine Measurement Carnitine Acetyl Transferase Measurement Free Carnitine Measurement Cast Present Or Absent Calcium Sulphate Measurement Complement Bb Measurement Cholecystokinin Measurement Cyclic Citrullinated Peptide Antibody Measurement CD19 Expressing B Cell Count CD19 B Cell to Lymphocyte Ratio Measurement CD3 Expressing T Cell Count CD34 Measurement CD3 T Cell to Lymphocyte Ratio Measurement CD4 Expressing T Cell Count CD40 Measurement CD40 Ligand Measurement CD4 T Cell to CD8 T Cell Ratio Measurement

C74606 C74635 C74607 C102260 C74636 C74608 C82006 C82007 C74637

CD19 CD19LY CD3 CD34 CD3LY CD4 CD40 CD40L CD4CD8

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 171 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym CD4/ Lymphocytes CD8 CD8/ Lymphocytes Carbohydrate-De ficient Transferrin Carcinoembryoni c Antigen Circulating Endothelial Cells Immature Cells Complement CH50; Total Hemolytic Complement; CH50 Cholesterol; Total Cholesterol Cholesterol/ HDL-Cholestero l Cholinesterase Citrate Creatine Kinase Creatine Kinase BB Creatine Kinase BB/Total Creatine Kinase Creatine Kinase MB Creatine Kinase MB/Total Creatine Kinase Creatine Kinase MM Creatine Kinase MM/Total Creatine Kinase

NCI Code C74638 C74609 C74639 C101016

CDISC Submission Value CD4LY CD8 CD8LY CDT

CDISC Definition A relative measurement (ratio or percentage) of CD4 T cells to all lymphocytes in a biological specimen. A count of the CD8 T cells per unit of a biological specimen. A relative measurement (ratio or percentage) of CD8 T cells to all lymphocytes in a biological specimen. A measurement of transferrin with a reduced number of carbohydrate moieties in a biological specimen. A measurement of the carcinoembryonic antigen in a biological specimen. A measurement of the circulating endothelial cells in a biological specimen. A measurement of the total immature cells in a blood specimen. A measurement of the complement required to lyse 50 percent of red blood cells in a biological specimen.

NCI Preferred Term CD4 T Cell to Lymphocyte Ratio Measurement CD8 Expressing T Cell Count CD8 T Cell to Lymphocyte Ratio Measurement Carbohydrate-Deficient Transferrin Measurement Carcinoembryonic Antigen Measurement Circulating Endothelial Cell Count Immature Cell Count CH50 Measurement

C81983 C96592 C96672 C100423

CEA CEC CELLSIM CH50

C61032

CHOL

A measurement of the cholesterol in a biological specimen. A relative measurement (ratio or percentage) of total cholesterol to high-density lipoprotein cholesterol (HDL-C) in a biological specimen. A measurement of the cholinesterase in a biological specimen. A measurement of the citrate in a biological specimen. A measurement of the total creatine kinase in a biological specimen. A measurement of the homozygous B-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the BB-type creatine kinase to total creatine kinase in a biological specimen. A measurement of the heterozygous MB-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the MB-type creatine kinase to total creatine kinase in a biological specimen. A measurement of the homozygous M-type creatine kinase in a biological specimen. A relative measurement (ratio or percentage) of the MM-type creatine kinase to total creatine kinase in a biological specimen.

Serum Total Cholesterol Measurement Cholesterol to HDL-Cholesterol Ratio Measurement Cholinesterase Measurement Citrate Measurement Creatine Kinase Measurement Creatine Kinase BB Measurement Creatine Kinase BB to Total Creatine Kinase Ratio Measurement Creatine Kinase MB Measurement Creatine Kinase MB to Total Creatine Kinase Ratio Measurement Creatine Kinase MM Measurement Creatine Kinase MM to Total Creatine Kinase Ratio Measurement

C80171

CHOLHDL

C92289 C92248 C64489 C64490 C79466

CHOLINES CITRATE CK CKBB CKBBCK

C64491 C79441

CKMB CKMBCK

C64494 C79442

CKMM CKMMCK

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 172 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Chloride Clarity Chloride/ Creatinine Calcitonin Calcitriol Clue Cells Cytomegalovirus IgG Antibody Cytomegalovirus IgM Antibody CMV Viral Load Carbon Dioxide Cocaine Codeine Color Urine Conductivity Cortisol, Free Cortisol; Total Cortisol Cotinine C-peptide Chlamydia pneumoniae IgA Antibody Chlamydia pneumoniae IgM Antibody Creatinine

NCI Code C64495 C96594 C79440 C74848 C74849 C102261 C96596 C96597 C98716 C64545 C74690 C74877 C64546 C102282

CDISC Submission Value CL CLARITY CLCREAT CLCTONN CLCTRIOL CLUECE CMVIGGAB CMVIGMAB CMVVLD CO2 COCAINE CODEINE COLOR CONDUCTU

CDISC Definition A measurement of the chloride in a biological specimen. A measurement of the transparency of a biological specimen. A relative measurement (ratio or percentage) of the chloride to creatinine in a biological specimen. A measurement of the calcitonin hormone in a biological specimen. A measurement of the calcitriol hormone in a biological specimen. A measurement of the clue cells in a biological specimen. A measurement of the cytomegalovirus IgG antibody in a biological specimen. A measurement of the cytomegalovirus IgM antibody in a biological specimen. A measurement of the cytomegalovirus viral load in a biological specimen. A measurement of the carbon dioxide gas in a biological specimen. A measurement of the cocaine present in a biological specimen. A measurement of the codeine present in a biological specimen. A measurement of the color of a biological specimen. A measurement of the urine conductivity which is a non-linear function of the electrolyte concentration in the urine. A measurement of the free, unbound cortisol in a biological specimen. A measurement of the cortisol in a biological specimen. A measurement of the cotinine in a biological specimen. A measurement of the C (connecting) peptide of insulin in a biological specimen. A measurement of the Chlamydia pneumoniae IgA antibody in a biological specimen. A measurement of the Chlamydia pneumoniae IgM in a biological specimen. A measurement of the creatinine in a biological specimen.

NCI Preferred Term Chloride Measurement Clarity Measurement Chloride to Creatinine Ratio Measurement Calcitonin Measurement Calcitriol Measurement Clue Cell Count Cytomegalovirus IgG Antibody Measurement Cytomegalovirus IgM Antibody Measurement Cytomegalovirus Viral Load Measurement Carbon Dioxide Measurement Cocaine Measurement Codeine Measurement Color Assessment Urine Conductivity

C88113 C74781 C92249 C74736 C92432

CORTFR CORTISOL COTININE CPEPTIDE CPNIGAAB

Free Cortisol Measurement Cortisol Measurement Cotinine Measurement C-peptide Measurement Chlamydia pneumoniae IgA Antibody Measurement Chlamydia pneumoniae IgM Antibody Measurement Creatinine Measurement

C92433

CPNIGMAB

C64547

CREAT

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 173 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Creatinine Clearance Crenated Cells; Echinocytes

NCI Code C25747

CDISC Submission Value CREATCLR

CDISC Definition A measurement of the volume of serum or plasma that would be cleared of creatinine by excretion of urine for a specified unit of time (e.g. one minute). A measurement of the Burr cells (erythrocytes characterized by the presence of multiple small, sharp projections evenly distributed across the cell surface) in a biological specimen. A measurement of the corticotropin releasing hormone in a biological specimen.

NCI Preferred Term Creatinine Clearance

C74703

CRENCE

Crenated Cell Measurement

C74851

CRH

Corticotropin Releasing Hormone; Corticotropin Releasing Factor Ceruloplasmin; Caeruloplasmin C Reactive Protein Corticosterone Crystals Bacterial Casts Broad Casts Cellular Casts

Corticotropin Releasing Hormone Measurement

C100432 C64548 C79434 C74673 C74762 C96588 C74764

CRLPLSMN CRP CRTRONE CRYSTALS CSBACT CSBROAD CSCELL

A measurement of ceruloplasmin in a biological specimen. A measurement of the C reactive protein in a biological specimen. A measurement of corticosterone in a biological specimen. A statement that indicates crystals were looked for in a biological specimen. A measurement of the bacterial casts present in a biological specimen. A measurement of the broad casts in a biological specimen. A measurement of the cellular (white blood cell, red blood cell, epithelial and bacterial) casts present in a biological specimen. A measurement of the epithelial cell casts present in a biological specimen. A measurement of the fatty casts present in a biological specimen. A measurement of the granular (coarse and fine) casts present in a biological specimen. A measurement of the coarse granular casts present in a biological specimen. A measurement of the fine granular casts present in a biological specimen. A measurement of the hyaline casts present in a biological specimen. A measurement of the mixed (the cast contains a mixture of cell types) casts present in a biological specimen. A measurement of the red blood cell casts present in a biological specimen. A measurement of the unclassifiable casts present in a biological specimen.

Ceruloplasmin Measurement C-Reactive Protein Measurement Corticosterone Measurement Crystal Present Or Absent Bacterial Cast Measurement Broad Casts Measurement Cellular Cast Measurement

C74779 C74766 C74768 C74765 C74769 C74770 C74771

CSEPI CSFAT CSGRAN CSGRANC CSGRANF CSHYAL CSMIX

Epithelial Casts Fatty Casts Granular Casts Granular Coarse Casts Granular Fine Casts Hyaline Casts Mixed Casts

Epithelial-Cast Measurement Fatty Cast Measurement Granular Cast Measurement Coarse Granular Cast Measurement Granular Fine Cast Measurement Hyaline Cast Measurement Mixed Cast Count

C74772 C74776

CSRBC CSUNCLA

RBC Casts Unclassified Casts

Red Blood Cell Cast Measurement Unclassified Cast Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 174 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Waxy Casts WBC Casts Circulating Tumor Cells Complement Total Chlamydia trachomatis IgA Antibody Chlamydia trachomatis IgG Antibody Chlamydia trachomatis IgM Antibody Type I Collagen C-Telopeptides; Type I Collagen X-linked C-telopeptide Type II Collagen C-Telopeptides Chemokine (C-X-C Motif) Receptor 3; GPR9, CD183, CXCR3 Acid Urate Crystals Ammonium Biurate Crystals; Ammonium Urate Crystals; Acid Ammonium Urate Crystals Ammonium Oxalate Crystals Amorphous Crystals Amorphous Phosphate Crystals Amorphous Urate Crystals

NCI Code C74777 C74778 C96593 C80160 C100464

CDISC Submission Value CSWAX CSWBC CTC CTOT CTRIGAAB

CDISC Definition A measurement of the waxy casts present in a biological specimen. A measurement of the white blood cell casts present in a biological specimen. A measurement of the circulating tumor cells in a biological specimen. A measurement of the total complement in a biological specimen. A measurement of the Chlamydia trachomatis IgA antibody in a biological specimen. A measurement of the Chlamydia trachomatis IgG antibody in a biological specimen. A measurement of the Chlamydia trachomatis IgM antibody in a biological specimen. A measurement of the type I collagen C-telopeptides in a biological specimen.

NCI Preferred Term Waxy Cell Cast Measurement White Blood Cell Cast Measurement Circulating Tumor Cell Count Complement Measurement Chlamydia trachomatis IgA Antibody Measurement Chlamydia trachomatis IgG Antibody Measurement Chlamydia trachomatis IgM Antibody Measurement Type I Collagen C-Telopeptide Measurement

C100466

CTRIGGAB

C100465

CTRIGMAB

C82038

CTXI

C82040 C100431

CTXII CXCR3

A measurement of the type II collagen C-telopeptides in a biological specimen. A measurement of the CXCR3, chemokine (C-X-C motif) receptor 3, in a biological specimen.

Type II Collagen C-Telopeptide Measurement Chemokine Receptor CXCR3 Measurement

C74912 C74758

CYACIDU CYAMMBIU

A measurement of the acid urate crystals present in a biological specimen. A measurement of the ammonium biurate crystals present in a biological specimen.

Acid Urate Crystal Measurement Urine Ammonium Biurate Crystal Measurement

C74759 C74665

CYAMMOX CYAMORPH

A measurement of the ammonium oxalate crystals present in a urine specimen. A measurement of the amorphous (Note: phosphate or urate, depending on pH) crystals present in a biological specimen. A measurement of the amorphous phosphate crystals in a biological specimen. A measurement of the amorphous urate crystals in a biological specimen.

Urine Ammonium Oxalate Crystal Measurement Amorphous Crystal Measurement

C92243

CYAMPPH

Amorphous Phosphate Crystals Measurement Amorphous Urate Crystals Measurement

C92244

CYAMPURT

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 175 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Bilirubin Crystals Calcium Carbonate Crystals Calcium Oxalate Crystals Calcium Phosphate Crystals Cholesterol Crystals Cystine Crystals Hippuric Acid Crystals Leucine Crystals Monosodium Urate Crystals Starch Crystals Cystatin C Sulfa Crystals Triple Phosphate Crystals Tyrosine Crystals Unclassified Crystals Uric Acid Crystals D-Dimer Dehydroepiandro sterone; Dehydroisoandro sterone Dehydroepiandro sterone Sulfate; DHEA-S; sDHEA; DHEA Sulfate

NCI Code C74668 C74669

CDISC Submission Value CYBILI CYCACAR

CDISC Definition A measurement of the bilirubin crystals present in a biological specimen. A measurement of the calcium carbonate crystals present in a biological specimen. A measurement of the calcium oxalate crystals present in a biological specimen. A measurement of the calcium phosphate crystals present in a biological specimen. A measurement of the cholesterol crystals present in a biological specimen. A measurement of the cystine crystals present in a biological specimen. A measurement of the hippuric acid crystals present in a biological specimen. A measurement of the leucine crystals present in a biological specimen. A measurement of the monosodium urate crystals present in a biological specimen. A measurement of the starch crystals in a biological specimen. A measurement of the cystatin C in a biological specimen. A measurement of the sulfa crystals present in a biological specimen. A measurement of the triple phosphate crystals present in a biological specimen. A measurement of the triple phosphate crystals present in a biological specimen. A measurement of the unclassifiable crystals present in a biological specimen. A measurement of the uric acid crystals present in a biological specimen. A measurement of the d-dimers in a biological specimen. A measurement of the dehydroepiandrosterone hormone in a biological specimen.

NCI Preferred Term Bilirubin Crystal Measurement Calcium Carbonate Crystal Measurement Calcium Oxalate Crystal Measurement Calcium Phosphate Crystal Measurement Cholesterol Crystal Measurement Cystine Crystal Measurement Hippuric Acid Crystal Measurement Leucine Crystal Measurement Monosodium Urate Crystal Measurement Starch Crystal Measurement Cystatin C Measurement Sulfa Crystal Measurement Triple Phosphate Crystal Measurement Tyrosine Crystal Measurement Unclassified Crystal Measurement Uric Acid Crystal Measurement D-Dimer Measurement Dehydroepiandrosterone Measurement

C74670 C74671

CYCAOXA CYCAPHOS

C74672 C74674 C74754 C74680 C74681 C81951 C92290 C74755 C74756 C74683 C74757 C74684 C82621 C74852

CYCHOL CYCYSTIN CYHIPPAC CYLEUC CYMSU CYSTARCH CYSTATC CYSULFA CYTRPHOS CYTYRO CYUNCLA CYURIAC DDIMER DHEA

C96629

DHEAS

A measurement of the sulfated Dehydroepiandrosterone in a biological specimen.

Sulfated DHEA Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 176 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym 3,4-Dihydroxyph enylglycol; 3.4 Dihydroxyphenyl glycol Dihydrotestoster one; Androstanalone Dihydrocodeine Anti-DNA Antibodies; Anti-ds-DNA Antibodies DNase-B Antibody; Anti-Dnase B Dohle Bodies

NCI Code C101017

CDISC Submission Value DHPG

CDISC Definition A measurement of the catecholamine metabolite, 3,4-Dihydroxyphenylglycol in a biological specimen.

NCI Preferred Term 3,4-Dihydroxyphenylglycol Measurement

C74853

DHT

A measurement of the dihydrotestosterone hormone in a biological specimen. A measurement of the dihydrocodeine present in a biological specimen. A measurement of the anti-DNA antibodies in a biological specimen.

Dihydrotestosterone Measurement

C74878 C81973

DIHYDCDN DNAAB

Dihydrocodeine Measurement Anti-DNA Antibody Measurement

C100463

DNASEBAB

A measurement of Dnase-B antibody in a biological specimen. A measurement of the Dohle bodies (blue-gray, basophilic, leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen. A measurement of the dopamine hormone in a biological specimen. A measurement of the deoxypyridinoline in a biological specimen. A relative measurement (ratio or percentage) of the deoxypyridinoline to creatinine in a biological specimen. An indication of the presence or absence of recreational drugs or drugs of abuse in a biological specimen. A measurement of the time it takes a plasma sample to clot after adding dilute Russell's viper venom. A measurement of the volume of serum or plasma that would be cleared of Diethylenetriamine pentaacetate (DTPA) through its excretion for a specified unit of time. A measurement of the Epstein-Barr capsid IgG antibody in a biological specimen. A measurement of the Epstein-Barr capsid IgM antibody in a biological specimen. A measurement of the Epstein-Barr early antigen in a biological specimen. A measurement of the Epstein-Barr nuclear antibody in a biological specimen.

DNase-B Antibody Measurement

C74610

DOHLE

Dohle Body Measurement

C74854 C79443 C79444

DOPAMINE DPD DPDCREAT

Dopamine Deoxypyridinoli ne Deoxypyridinoli ne/Creatinine Drug Screen

Dopamine Measurement Deoxypyridinoline Measurement Deoxypyridinoline to Creatinine Ratio Measurement Drug Test

C78139

DRUGSCR

C96696

DRVVT

Dilute Russell's Viper Venom Time DTPA Clearance

Dilute Russell's Viper Venom Time Measurement Diethylene Triamine Pentaacetic Acid Clearance

C100441

DTPACLR

C96600

EBCIGGAB

Epstein-Barr Capsid IgG Antibody Epstein-Barr Capsid IgM Antibody Epstein-Barr Early Antigen Epstein-Barr Nuclear Antibody

Epstein-Barr Capsid IgG Antibody Measurement Epstein-Barr Capsid IgM Antibody Measurement Epstein-Barr Early Antigen Measurement Epstein-Barr Nuclear Antibody Measurement

C96601

EBCIGMAB

C96602 C96603

EBEAG EBNAB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 177 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Epstein-Barr Nuclear Antigen EBV Viral Load Eccentrocytes

NCI Code C96604 C98721 C96598

CDISC Submission Value EBNAG EBVVLD ECCENTCY

CDISC Definition A measurement of the Epstein-Barr nuclear antigen in a biological specimen. A measurement of the Epstein-Barr virus viral load in a biological specimen. A measurement of the eccentrocytes (erythrocytes in which the hemoglobin is localized to a particular portion of the cell, noticeable as localized staining) in a biological specimen. A measurement of the activity of thrombin inhibitors in a biological specimen based on the generation of meizothrombin. A measurement of the volume of serum or plasma that would be cleared of Ethylenediamine tetraacetic acid (EDTA) through its excretion for a specified unit of time. A measurement of the epidermal growth factor in a biological specimen. A measurement of the pancreatic elastase 1 in a biological specimen. A measurement of the polymorphonuclear pancreatic elastase 1 in a biological specimen.

NCI Preferred Term Epstein-Barr Nuclear Antigen Measurement Epstein-Barr Virus Viral Load Measurement Eccentrocyte Count

C100422

ECT

Ecarin Clotting Time EDTA Clearance

Ecarin Clotting Time Measurement

C100440

EDTACLR

EDTA Clearance

C82009 C82028 C82029

EGF ELA1 ELA1PMN

Epidermal Growth Factor Pancreatic Elastase 1 Pancreatic Elastase 1, Polymorphonucl ear Neutrophil Elastase Neutrophil Elastase, Polymorphonucl ear Elliptocytes; Ovalocytes Epith Neutrophil-Activ ating Peptide 78 Anti-ENA; Extractable Nuclear Antigen Antibody Endothelin-1

Epidermal Growth Factor Measurement Pancreatic Elastase Measurement Polymorphonuclear Pancreatic Elastase Measurement

C82026 C82027

ELA2 ELA2PMN

A measurement of the neutrophil elastase in a biological specimen. A measurement of the polymorphonuclear neutrophil elastase in a biological specimen.

Neutrophil Elastase Measurement Polymorphonuclear Neutrophil Elastase Measurement

C64549 C82010

ELLIPCY ENA78

A measurement of the elliptically shaped erythrocytes in a biological specimen. A measurement of the epithelial neutrophil-activating peptide in a biological specimen. A measurement of the extractable nuclear antigen antibody in a biological specimen.

Elliptocyte Count Epithelial Neutrophil-Activating Peptide 78 Measurement Extractable Nuclear Antigen Antibody Measurement

C92270

ENAAB

C82008 C82011

ENDOTH1 ENRAGE

A measurement of the endothelin-1 in a biological specimen.

Endothelin-1 Measurement Extracell Newly Ident RAGE Bind Protein Measurement

Extracell Newly A measurement of the extracellular newly identified Ident RAGE Bind RAGE (receptor for advanced glycation end products) Protein; S100 binding protein in a biological specimen. Calcium Binding Protein A12 Eosinophils A measurement of the eosinophils in a biological specimen.

C64550

EOS

Eosinophil Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 178 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Eosinophils/ Total Cells Immature Eosinophils Immature Eosinophils/ Leukocytes Eosinophils/ Leukocytes Eosinophilic Metamyelocytes Eosinophilic Myelocytes Eotaxin-1; Chemokine Ligand 11 Eotaxin-2; Chemokine Ligand 24 Eotaxin-3; Chemokine Ligand 26 Epithelial Cells Epinephrine; Adrenaline Round Epithelial Cells Squamous Epithelial Cells Squamous Transitional Epithelial Cells; Epithelial Cells Transitional Epithelial Cells Tubular Epithelial Cells; Renal Tubular Epithelial Cells Erythropoietin; Hematopoietin Erythrocyte Sedimentation Rate; Biernacki Reaction

NCI Code C98720

CDISC Submission Value EOSCE

CDISC Definition A relative measurement (ratio or percentage) of the eosinophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the immature eosinophils in a biological specimen. A relative measurement (ratio or percentage) of immature eosinophils to total leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. A measurement of the eosinphilic metamyelocytes in a biological specimen. A measurement of the eosinophilic myelocytes in a biological specimen. A measurement of the eotaxin-1 in a biological specimen. A measurement of the eotaxin-2 in a biological specimen. A measurement of the eotaxin-3 in a biological specimen. A measurement of the epithelial cells in a biological specimen. A measurement of the epinephrine hormone in a biological specimen. A measurement of the round epithelial cells present in a biological specimen. A measurement of the squamous epithelial cells present in a biological specimen. A measurement of the squamous transitional epithelial cells present in a biological specimen.

NCI Preferred Term Eosinophils to Total Cell Ratio Measurement Immature Eosinophil Count Immature Eosinophil to Leukocyte Ratio Measurement Eosinophil To Leukocyte Ratio Eosinophilic Metamyelocyte Count Eosinophilic Myelocyte Count Eotaxin-1 Measurement

C96673 C96674

EOSIM EOSIMLE

C64604 C84819 C84821 C81952

EOSLE EOSMM EOSMYL EOTAXIN1

C81953

EOTAXIN2

Eotaxin-2 Measurement

C81954

EOTAXIN3

Eotaxin-3 Measurement

C64605 C79445 C74698 C74773 C74774

EPIC EPIN EPIROCE EPISQCE EPISQTCE

Epithelial Cell Count Epinephrine Measurement Round Epithelial Cell Count Squamous Epithelial Cell Count Squamous Transitional Epithelial Cell Count

C92251 C74775

EPITCE EPITUCE

A measurement of the transitional epithelial cells present in a biological specimen. A measurement of the tubular epithelial cells present in a biological specimen.

Transitional Epithelial Cells Measurement Tubular Epithelial Cell Count

C74855 C74611

EPO ESR

A measurement of the erythropoietin hormone in a biological specimen. The distance (e.g. millimeters) that red blood cells settle in unclotted blood over a specified unit of time (e.g. one hour).

Erythropoietin Measurement Erythrocyte Sedimentation Rate Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 179 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Estradiol; Oestradiol Estriol; Oestriol Estriol, Free Estrone; Oestrone Ethanol; Alcohol Endogenous Thrombin Potential ETP Area Under Curve; Endogenous Thrombin Potential Area Under Curve ETP Lag Time; Endogenous Thrombin Potential Lag Time ETP Lag Time Relative; Endogenous Thrombin Potential Lag Time Relative ETP Peak Height; Endogenous Thrombin Potential Peak Height ETP Peak Height Relative; Endogenous Thrombin Potential Peak Height Relative ETP Time to Peak; Endogenous Thrombin Potential Time to Peak

NCI Code C74782 C74856 C81963 C74857 C74693 C102266

CDISC Submission Value ESTRDIOL ESTRIOL ESTRIOLF ESTRONE ETHANOL ETP

CDISC Definition A measurement of the estradiol in a biological specimen. A measurement of the estriol hormone in a biological specimen. A measurement of the free estriol in a biological specimen. A measurement of the estrone hormone in a biological specimen. A measurement of the ethanol present in a biological specimen. A measurement of the total concentration of thrombin generated in the presence of a substrate in a plasma or blood sample. A measurement of the area under the thrombin generation curve.

NCI Preferred Term Estradiol Measurement Estriol Measurement Free Estriol Measurement Estrone Measurement Ethanol Measurement Endogenous Thrombin Potential Measurement Endogenous Thrombin Potential Area Under Curve Measurement

C102263

ETPAUC

C102264

ETPLT

A measurement of time from the start of the thrombin generation test to the point where a predetermined amount of thrombin is generated.

Endogenous Thrombin Potential Lag Time Measurement

C102265

ETPLTR

A relative measurement (ratio or percentage) of time from the start of the thrombin generation test to the point where a predetermined amount of thrombin is generated.

Endogenous Thrombin Potential Lag Time Relative Measurement

C102267

ETPPH

A measurement of the maximum concentration of thrombin generated during a thrombin generation test.

Endogenous Thrombin Potential Peak Height Measurement

C102268

ETPPHR

A relative (ratio or percentage) of the maximum concentration of thrombin generated during a thrombin generation test.

Endogenous Thrombin Potential Peak Height Relative Measurement

C102269

ETPTP

A measurement of the time it takes to generate the maximum concentration of thrombin.

Endogenous Thrombin Potential Time to Peak Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 180 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym ETP Time to Peak Relative; Endogenous Thrombin Potential Time to Peak Relative Fatty Acid Binding Protein 1 Factor II; Prothrombin Factor III; Tissue Factor, CD142 Factor IX Factor V Factor VII Factor VIII Factor V Leiden von Willebrand Factor; von Willebrand Factor Antigen Factor X Factor XIV; Autoprothrombin IIA; Protein C Fat Free Fatty Acid; Non-Esterified Fatty Acid, Free Free Fatty Acid, Saturated; Non-esterified Fatty Acid, Saturated Free Fatty Acid, Unsaturated; Non-esterified Fatty Acid, Unsaturated

NCI Code C102270

CDISC Submission Value ETPTPR

CDISC Definition A relative (ratio or percentage) measurement of the time it takes to generate the maximum concentration of thrombin.

NCI Preferred Term Endogenous Thrombin Potential Time to Peak Relative Measurement

C82012

FABP1

A measurement of the fatty acid binding protein 1 in a biological specimen. A measurement of the Factor II in a biological specimen. A measurement of the factor III in a biological specimen. A measurement of the factor IX in a biological specimen. A measurement of the factor V in a biological specimen. A measurement of the factor VII in a biological specimen. A measurement of the factor VIII in a biological specimen. A measurement of the Factor V Leiden in a biological specimen. A measurement of the von Willebrand factor in a biological specimen.

Fatty Acid Binding Protein 1 Measurement Prothrombin Measurement Factor III Measurement Factor IX Measurement Factor V Measurement Factor VII Measurement Factor VIII Measurement Factor V Leiden Measurement von Willebrand Factor Measurement

C96626 C81959 C98725 C98726 C81960 C81961 C102271 C98799

FACTII FACTIII FACTIX FACTV FACTVII FACTVIII FACTVL FACTVW

C98727 C102272

FACTX FACTXIV

A measurement of the factor X in a biological specimen. A measurement of the factor XIV in a biological specimen. A measurement of the fat in a biological specimen. A measurement of the total non-esterified fatty acids in a biological specimen. A measurement of the saturated non-esterified fatty acids in a biological specimen.

Factor X Measurement Factor XIV Measurement

C96648 C80200

FAT FATACFR

Fat Measurement Non-esterified Fatty Acids Measurement Saturated Non-esterified Fatty Acids Measurement

C80206

FATACFRS

C80209

FATACFRU

A measurement of the unsaturated non-esterified fatty acids in a biological specimen.

Unsaturated Non-esterified Fatty Acids Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 181 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Fat Bodies, Oval

NCI Code C81947

CDISC Submission Value FATBODOV

CDISC Definition A measurement of the oval-shaped fat bodies, usually renal proximal tubular cells with lipid aggregates in the cytoplasm, in a biological specimen. A measurement of the triglyceride aggregates within a biological specimen. A measurement of the fibrin degradation products in a biological specimen. A measurement of the ferritin in a biological specimen. A measurement of the fibroblast growth factor 23 in a biological specimen. A measurement of the basic form of fibroblast growth factor in a biological specimen.

NCI Preferred Term Oval Fat Body Measurement

C98728 C82013

FATDROP FDP

Fat Droplet Fibrin Degradation Products Ferritin Fibroblast Growth Factor 23; Phosphatonin Fibroblast Growth Factor Basic Form; FGF2 Fibrinogen Fructosamine; Glycated Serum Protein Follicle Stimulating Hormone Glucose-6-Phos phate Dehydrogenase Glutamic Acid Decarboxylase 1; Glutamic Acid Decarboxylase 67 Glutamic Acid Decarboxylase 2; Glutamic Acid Decarboxylase 65 Glutamic Acid Decarboxylase 2 Antibody; Glutamic Acid Decarboxylase 65 Antibody Glutamic Acid Decarboxylase Antibody; GAD Antibody Galanin

Fat Droplet Measurement Fibrin Degradation Products Measurement Ferritin Measurement Fibroblast Growth Factor 23 Measurement Fibroblast Growth Factor Basic Form Measurement

C74737 C96650

FERRITIN FGF23

C82014

FGFBF

C64606 C74678

FIBRINO FRUCT

A measurement of the fibrinogen in a biological specimen. A measurement of the fructosamine in a biological specimen. A measurement of the follicle stimulating hormone (FSH) in a biological specimen. A measurement of the glucose-6-phosphate dehydrogenase in a biological specimen. A measurement of the glutamic acid decarboxylase 1 in a biological specimen.

Fibrinogen Measurement Fructosamine Measurement

C74783

FSH

Follicle Stimulating Hormone Measurement Glucose-6-Phosphate Dehydrogenase Measurement Glutamic Acid Decarboxylase 1 Measurement

C80184

G6PD

C82015

GAD1

C82016

GAD2

A measurement of the glutamic acid decarboxylase 2 in a biological specimen.

Glutamic Acid Decarboxylase 2 Measurement

C82017

GAD2AB

A measurement of the glutamic acid decarboxylase 2 antibody in a biological specimen.

Glutamic Acid Decarboxylase 2 Antibody Measurement

C96653

GADAB

A measurement of the glutamic acid decarboxylase antibody in a biological specimen.

Glutamic Acid Decarboxylase Antibody Measurement

C80182

GALANIN

A measurement of the galanin in a biological specimen.

Galanin Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 182 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Gastrin Granulocyte Colony Stimulating Factor Glomerular Filtration Rate Glomerular Filtration Rate Adj for BSA GFR from B-2 Microglobulin Adj for BSA GFR from Beta-Trace Protein Adj for BSA GFR from Creatinine Adjusted for BSA GFR from Cystatin C Adjusted for BSA

NCI Code C74858 C82018

CDISC Submission Value GASTRIN GCSF

CDISC Definition A measurement of the gastrin hormone in a biological specimen. A measurement of the granulocyte colony stimulating factor in a biological specimen.

NCI Preferred Term Gastrin Measurement Granulocyte Colony Stimulating Factor Measurement

C90505

GFR

A kidney function test that measures the fluid volume that is filtered from the kidney glomeruli to the Bowman's capsule per unit of time. A measurement of the glomerular filtration rate adjusted for body size. A measurement of the glomerular filtration rate (GFR) based on the clearance of beta-2 microglobulin after adjusting it for the body surface area. A measurement of the glomerular filtration rate (GFR) based on the clearance of beta-trace protein after adjusting it for the body surface area. An estimation of the glomerular filtration rate adjusted for body size based on creatinine.

Glomerular Filtration Rate

C98734

GFRBSA

Glomerular Filtration Rate Adjusted for BSA Glomerular Filtration Rate from B-2 Microglobulin Adjusted for BSA Measurement Glomerular Filtration Rate from Beta-Trace Protein Adjusted for BSA Measurement Glomerular Filtration Rate from Creatinine Adjusted for BSA

C100450

GFRBSB2M

C100449

GFRBSBTP

C98735

GFRBSCRT

C98736

GFRBSCYC

An estimation of the glomerular filtration rate adjusted for body size based on cystatin C.

Glomerular Filtration Rate from Cystatin C Adjusted for BSA

C64847 C79446

GGT GGTCREAT

Gamma Glutamyl A measurement of the gamma glutamyl transferase in a Transferase biological specimen. Gamma Glutamyl A relative measurement (ratio or percentage) of the Transferase/ gamma glutamyl transferase to creatinine in a Creatinine biological specimen. Glutamate Dehydrogenase Alpha-1 Globulin; A1-Globulin Alpha-1 Globulin/Total Protein Alpha-2 Globulin; A2-Globulin Alpha-2 Globulin/Total Protein Beta Globulin A measurement of the glutamate dehydrogenase in a biological specimen. A measurement of the proteins contributing to the alpha 1 fraction in a biological specimen. A relative measurement (ratio or percentage) of alpha-1-fraction proteins to total proteins in a biological specimen. A measurement of the proteins contributing to the alpha 2 fraction in a biological specimen. A relative measurement (ratio or percentage) of alpha-2-fraction proteins to total proteins in a biological specimen. A measurement of the proteins contributing to the beta fraction in a biological specimen.

Gamma Glutamyl Transpeptidase Measurement Gamma Glutamyl Transferase to Creatinine Ratio Measurement Glutamate Dehydrogenase Measurement Alpha-1 Globulin Measurement

C79448 C92252

GLDH GLOBA1

C92253

GLOBA1PT

Alpha-1 Globulin to Total Protein Ratio Measurement Alpha-2 Globulin Measurement

C92254

GLOBA2

C92255

GLOBA2PT

Alpha-2 Globulin to Total Protein Ratio Measurement Beta Globulin Measurement

C92256

GLOBB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 183 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Beta Globulin/Total Protein Gamma Globulin Gamma Globulin/Total Protein Globulin Glucagon-Like Peptide-1; Total Glucagon-Like Peptide-1 Glucagon-Like Peptide-1, Active Form Glucose Glucagon Glucose Clearance Glucose/ Creatinine Glutamate; Glutamic Acid Free Glycerol; Free Glycerin Granulocyte Macrophage Colony Stm Factor Gonadotropin Releasing Hormone; Luteinising Hormone Releasing Hormone Gold Granulocytes Granulocytes/ Total Cells Immature Granulocytes

NCI Code C92294

CDISC Submission Value GLOBBPT

CDISC Definition A relative measurement (ratio or percentage) of beta fraction proteins to total proteins in a biological specimen. A measurement of the proteins contributing to the gamma fraction in a biological specimen. A relative measurement (ratio or percentage) of gamma fraction proteins to total proteins in a biological specimen. A measurement of the globulin protein in a biological specimen. A measurement of the total glucagon-like peptide-1 in a biological specimen.

NCI Preferred Term Beta Globulin to Total Protein Ratio Measurement Gamma Globulin Measurement Gamma Globulin to Total Protein Ratio Measurement Globulin Protein Measurement Glucagon-like Peptide-1 Measurement

C92257 C92295

GLOBG GLOBGPT

C74738 C80183

GLOBUL GLP1

C80164

GLP1AC

A measurement of the active form of glucagon-like peptide-1 in a biological specimen. A measurement of the glucose in a biological specimen. A measurement of the glucagon hormone in a biological specimen. A measurement of the glucose clearance in a biological specimen. A relative measurement (ratio or percentage) of the glucose to creatinine in a biological specimen. A measurement of the glutamate in a biological specimen. A measurement of the amount of unbound glycerol in a biological specimen. A measurement of the granulocyte macrophage colony stimulating factor in a biological specimen.

Active Glucagon-like Peptide-1 Measurement Plasma Glucose Measurement Glucagon Measurement Glucose Clearance Measurement Glucose to Creatinine Ratio Measurement Glutamate Measurement Free Glycerol Measurement Granulocyte Macrophage Colony Stm Factor Measurement

C41376 C74859 C96652 C79447 C74739 C100448 C82019

GLUC GLUCAGON GLUCCLR GLUCCRT GLUTAM GLYCRLFR GMCSF

C74860

GNRH

A measurement of the gonadotropin releasing hormone in a biological specimen.

Gonadotropin Releasing Hormone Measurement

C80186 C96654 C98866

GOLD GRAN GRANCE

A measurement of the gold in a biological specimen. A measurement of the granulocytes in a biological specimen. A relative measurement (ratio or percentage) of the granulocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the total immature granulocytes in a biological specimen.

Gold Measurement Granulocyte Count Granulocyte to Total CellRatio Measurement Immature Granulocyte Count

C96675

GRANIM

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 184 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Immature Granulocytes/ Leukocytes Growth Hormone Inhibiting Hormone; Somatostatin Growth Hormone Releasing Hormone; Somatocrinin Glutathione S-Transferase, Total Alpha Glutathione-S-Tr ansferase Glutathione S-Transferase, Alpha/Creat Glutathione-S-Tr ansferase/ Creatinine Mu Glutathione-S-Tr ansferase Mu Glutathione-S-Tr ansferase/ Creatinine Glutathione S-Transferase, Pi Glutathione S-Transferase, Theta Glucuronidase, Alpha Glucuronidase, Beta Hepatitis A Virus Antibody Hepatitis A Virus Antibody IgM Hairy Cells

NCI Code C100445

CDISC Submission Value GRANIMLE

CDISC Definition A relative measurement (ratio or percentage) of the immature granulocytes to leukocytes in a biological specimen (for example a bone marrow specimen). A measurement of the growth hormone inhibiting hormone in a biological specimen.

NCI Preferred Term Immature Granulocytes to Leukocytes Ratio Measurement Growth Hormone Inhibiting Hormone Measurement

C74861

GRWHIH

C74862

GRWHRH

A measurement of the growth hormone releasing hormone in a biological specimen.

Growth Hormone Releasing Hormone Measurement

C80185

GST

A measurement of the total glutathione-s-transferase in a biological specimen. A measurement of the alpha form of glutathione S-transferase in a biological specimen. A relative measurement (ratio or percentage) of the alpha glutathione-S-transferase to creatinine in a biological specimen. A relative measurement (ratio or percentage) of the glutathione S-transferase to creatinine in a biological specimen. A measurement of the mu form of glutathione S-transferase in a biological specimen. A relative measurement (ratio or percentage) of the mu gamma glutamyl transpeptidase to creatinine in a biological specimen. A measurement of the Pi glutathione-s-transferase in a biological specimen. A measurement of the theta glutathione-s-transferase in a biological specimen. A measurement of the alpha glucuronidase in a biological specimen. A measurement of the beta glucuronidase in a biological specimen. A measurement of the antibody reaction of a biological specimen to the Hepatitis A virus. A measurement of hepatitis A virus antibody IgM in a biological specimen. A measurement of the hairy cells (b-cell lymphocytes with hairy projections from the cytoplasm) in a biological specimen.

Glutathione-S-Transferase Measurement Alpha Glutathione-S-Transferase Measurement Alpha Glutathione-S-Transferase to Creatinine Ratio Measurement Glutathione-S-Transferase to Creatinine Ratio Measurement Mu Glutathione-S-Transferase Measurement Mu Glutathione-S-Transferase to Creatinine Ratio Measurement

C79433

GSTAL

C80166

GSTALCRT

C79435

GSTCREAT

C79457

GSTMU

C79458

GSTMUCRT

C80203 C80207

GSTPI GSTTH

Pi Glutathione S-Transferase Measurement Theta Glutathione S-Transferase Measurement Alpha Glucuronidase Measurement Beta Glucuronidase Measurement Hepatitis A Antibody Measurement Hepatitis A Virus Antibody IgM Measurement Hairy Cell Count

C80165 C80170 C92534 C92271 C74604

GUSA GUSB HAAB HAABIGM HAIRYCE

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 185 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Haptoglobin Human Anti-Sheep IgE Antibody Human Anti-Sheep IgG Antibody Human Anti-Sheep IgM Antibody HAV Viral Load Hemoglobin A1C Hepatitis B Virus Core Antibody Hepatitis B Virus Core IgM Antibody Hepatitis B Virus e Antibody Hepatitis B Virus e Antigen Anti-HBs; HBsAb; Hepatitis B Virus Surface Antibody HBsAg; Hepatitis B Virus Surface Antigen HBV Viral Load Hepatitis C Virus Antibody Choriogonadotro pin Beta; Pregnancy Test Hematocrit HCV Viral Load Hepatitis D Virus Antibody; Hepatitis Delta Antibody

NCI Code C74740 C98740

CDISC Submission Value HAPTOG HASIGEAB

CDISC Definition A measurement of the haptoglobin protein in a biological specimen. A measurement of the human anti-sheep IgE antibodies in a biological specimen. A measurement of the human anti-sheep IgG antibodies in a biological specimen. A measurement of the human anti-sheep IgM antibodies in a biological specimen. A measurement of the hepatitis A viral load in a biological specimen. A measurement of the glycosylated hemoglobin in a biological specimen. A measurement of the hepatitis B virus core antibody in a biological specimen. A measurement of the hepatitis B virus core IgM antibody in a biological specimen. A measurement of the hepatitis B e antibody in a biological specimen. A measurement of the hepatitis B e antigen in a biological specimen. A measurement of the surface antibody reaction of a biological specimen to the Hepatitis B virus.

NCI Preferred Term Haptoglobin Protein Measurement Human Anti-Sheep IgE Antibody Measurement Human Anti-Sheep IgG Antibody Measurement Human Anti-Sheep IgM Antibody Measurement Hepatitis A Viral Load Measurement Glycosylated Hemoglobin Measurement Hepatitis B Virus Core Antibody Measurement Hepatitis B Virus Core IgM Antibody Measurement Hepatitis B Virus e Antibody Measurement Hepatitis B Virus e Antigen Measurement Hepatitis B Surface Antibody Measurement

C98741

HASIGGAB

C98742

HASIGMAB

C92541 C64849 C96660 C96661

HAVVLD HBA1C HBCAB HBCIGMAB

C96662 C96663 C74711

HBEAB HBEAG HBSAB

C64850

HBSAG

A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus. A measurement of the hepatitis B viral load in a biological specimen. A measurement of the antibody reaction of a biological specimen to the Hepatitis C virus. A measurement of the Choriogonadotropin Beta in a biological specimen. The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes). A measurement of the hepatitis C viral load in a biological specimen. A measurement of the hepatitis D virus antibody in a biological specimen.

Hepatitis B Virus Surface Antigen Measurement Hepatitis B Viral Load Measurement Hepatitis C Antibody Measurement Choriogonadotropin Beta Measurement Hematocrit Hepatitis C Viral Load Measurement Hepatitis D Virus Antibody Measurement

C92542 C92535 C64851

HBVVLD HCAB HCG

C64796 C92543 C96664

HCT HCVVLD HDAB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 186 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym HDL Cholesterol HDL-Cholestero l Subclass 2 HDL-Cholestero l Subclass 3 HDL Cholesterol/LDL Cholesterol Ratio Hepatitis E Virus IgM Antibody Heinz Bodies; Heinz-Erhlich Bodies Helmet Cells

NCI Code C61041 C80187 C80188 C100425

CDISC Submission Value HDL HDL2 HDL3 HDLCLDLC

CDISC Definition A measurement of the high density lipoprotein cholesterol in a biological specimen. A measurement of the high-density lipoprotein (HDL) cholesterol subclass 2 in a biological specimen. A measurement of the high-density lipoprotein (HDL) cholesterol subclass 3 in a biological specimen. A relative measurement (ratio or percentage) of the amount of HDL cholesterol compared to LDL cholesterol in a biological specimen. A measurement of the hepatitis E virus IgM antibody in a biological specimen. A measurement of the Heinz bodies (small round inclusions within the body of a red blood cell) in a biological specimen. A measurement of the Helmet cells (specialized Keratocytes with two projections on either end that are tapered and hornlike) in a biological specimen. A measurement of the hexokinase in a biological specimen. A measurement of the hemoglobin in a biological specimen. A measurement of the hemoglobin A in a biological specimen. A measurement of the hemoglobin A2 in a biological specimen. A measurement of the hemoglobin B in a biological specimen. A measurement of the hemoglobin C in a biological specimen. A measurement of the hemoglobin F in a biological specimen. A measurement of the methemoglobin in a biological specimen. A measurement of the oxyhemoglobin in a biological specimen. A measurement of the Hepatitis G RNA in a biological specimen. A measurement of the histamine in a biological specimen. A measurement of the antibody reaction of a biological specimen to the either the HIV-1 or HIV-2 virus. A measurement of the antibody reaction of a biological specimen to the HIV-1 virus.

NCI Preferred Term Serum HDL Cholesterol Measurement HDL-Cholesterol Subclass 2 Measurement HDL-Cholesterol Subclass 3 Measurement HDL Cholesterol to LDL Cholesterol Ratio Measurement

C96665 C74709

HEIGMAB HEINZ

Hepatitis E Virus IgM Antibody Measurement Heinz-Ehrlich Body Measurement

C74658

HELMETCE

Helmet Cell Count

C96668 C64848 C92258 C92259 C92260 C92261 C92262

HEXK HGB HGBA HGBA2 HGBB HGBC HGBF

Hexokinase Hemoglobin Hemoglobin A Hemoglobin A2 Hemoglobin B Hemoglobin C Hemoglobin F; Fetal Hemoglobin Methemoglobin Oxyhemoglobin Hepatitis G RNA Histamine HIV-1/2 Antibody HIV-1 Antibody

Hexokinase Measurement Hemoglobin Measurement Hemoglobin A Measurement Hemoglobin A2 Measurement Hemoglobin B Measurement Hemoglobin C Measurement Hemoglobin F Measurement

C96689 C96616 C92272 C80189 C74714

HGBMET HGBOXY HGRNA HISTAMIN HIV12AB

Methemoglobin Measurement Oxyhemoglobin Measurement Hepatitis G RNA Measurement Histamine Measurement HIV-1 HIV-2 Antibody Measurement

C74713

HIV1AB

HIV-1 Antibody Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 187 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym HIV-2 Antibody HIV-2 Nucleic Acid HIV-1 p24 Antigen HIV-1 Group M and O Nucleic Acid HIV-1 Group O Antibody HIV Viral Load HLA-B27 Antigen; Human Leukocyte Antigen B27 Hemosiderin Homostat Model Assess of Insulin Rstn; Homeostatic Model Assessment of Insulin Resistance Homocysteine Howell-Jolly Bodies

NCI Code C74715 C92266 C92265 C92263

CDISC Submission Value HIV2AB HIV2NUAC HIVI24AG HIVIMONA

CDISC Definition A measurement of the antibody reaction of a biological specimen to the HIV-2 virus. A measurement of the HIV-2 nucleic acids in a biological specimen. A measurement of the HIV-1 p24 antigen in a biological specimen. A measurement of the HIV-1 group M and O nucleic acids in a biological specimen. A measurement of the HIV-1 group O antibody in a biological specimen. A measurement of the HIV viral load in a biological specimen. A measurement of the human leukocyte antigen B27 (HLA-B27) in a biological specimen.

NCI Preferred Term HIV-2 Antibody Measurement HIV-2 Nucleic Acid Measurement HIV-1 p24 Antigen Measurement HIV-1 Group M and O Nucleic Acid Measurement HIV-1 Group O Antibody Measurement HIV Viral Load Measurement HLA-B27 Antigen Measurement

C92264 C92544 C100460

HIVIOAB HIVVLD HLAB27AG

C96659 C100447

HMOSIDRN HOMAIR

A measurement of the hemosiderin complex in a biological specimen. An assessment of beta-cell function and insulin resistance based on fasting blood glucose and insulin concentrations.

Hemosiderin Measurement Homeostatic Model Assessment of Insulin Resistance

C74741 C74704

HOMOCY HOWJOL

A measurement of the homocysteine amino acid in a biological specimen. A measurement of the Howell-Jolly bodies (spherical, blue-black condensed DNA inclusions within the body of a red blood cell that appear under Wright-stain) in a biological specimen. An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level. A relative measurement (ratio or percentage) of the hairy cells (b-cell lymphocytes with hairy projections from the cytoplasm) to all lymphocytes in a biological specimen . A measurement of the herpes simplex virus 1 and 2 IgG antibody in a biological specimen.

Homocysteine Acid Measurement Howell-Jolly Body Measurement

C64802

HPOCROM

Hypochromia

Hypochromia

C74640

HRYCELY

Hairy Cells/ Lymphocytes Herpes Simplex Virus 1/2 IgG Antibody; HSV-1/2 IgG Ab Herpes Simplex Virus 1/2 IgM Antibody; HSV-1/2 IgM Ab

Hairy Cell to Lymphocyte Ratio Measurement

C96698

HS12GGAB

Herpes Simplex Virus 1/2 IgG Antibody Measurement

C96666

HS12GMAB

A measurement of the herpes simplex virus 1 and 2 IgM antibody in a biological specimen.

Herpes Simplex Virus 1/2 IgM Antibody Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 188 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Herpes Simplex Virus 1 IgG Antibody; HSV-1 IgG Antibody Herpes Simplex Virus 1 IgM Antibody Herpes Simplex Virus 2 IgG Antibody; HSV-2 IgG Antibody Herpes Simplex Virus 2 IgM Antibody Heterophile Antibodies Homovanillic Acid Hydrocodone Hydromorphone Hydrogen Hyperchromia Hydroxyproline Hypersegmented Cells Influenza A H1N1 Viral Load Total Iron Binding Capacity Unsaturated Iron Binding Capacity Islet Cell 512 Antibody Islet Cell 512 Antigen Interferon Alpha Interferon Beta Interferon Gamma

NCI Code C96697

CDISC Submission Value HS1IGGAB

CDISC Definition A measurement of the herpes simplex virus 1 IgG antibody in a biological specimen.

NCI Preferred Term Herpes Simplex Virus 1 IgG Antibody Measurement

C98738

HS1IGMAB

A measurement of the Herpes Simplex virus 1 IgM antibodies in a biological specimen. A measurement of the herpes simplex virus 2 IgG antibody in a biological specimen.

Herpes Simplex Virus 1 IgM Antibody Measurement Herpes Simplex Virus 2 IgG Antibody Measurement

C96667

HS2IGGAB

C98739

HS2IGMAB

A measurement of the Herpes Simplex virus 2 IgM antibodies in a biological specimen. A measurement of the heterophile antibodies in a biological specimen. A measurement of the homovanillic acid metabolite in a biological specimen. A measurement of the hydrocodone present in a biological specimen. A measurement of the hydromorphone present in a biological specimen. A measurement of the hydrogen in a biological specimen. A measurement of the prevalence of the erthrocytes with an elevated hemoglobin concentration. A measurement of the total hydroxyproline in a biological specimen. A measurement of the hypersegmented (more than five lobes) neutrophils in a biological specimen. A measurement of the Influenza A H1N1 viral load in a biological specimen. A measurement of the amount of iron needed to fully saturate the transferrin in a biological specimen. A measurement of the binding capacity of unsaturated iron in a biological specimen. A measurement of the islet cell 512 antibody in a biological specimen. A measurement of the islet cell 512 antigen in a biological specimen. A measurement of the interferon alpha in a biological specimen. A measurement of the interferon beta in a biological specimen. A measurement of the interferon gamma in a biological specimen.

Herpes Simplex Virus 2 IgM Antibody Measurement Heterophile Antibody Measurement Homovanillic Acid Measurement Hydrocodone Measurement Hydromorphone Measurement Hydrogen Measurement Hyperchromia Measurement Hydroxyproline Measurement Hypersegmented Neutrophil Measurement Influenza A H1N1 Viral Load Measurement Total Iron Binding Capacity Unsaturated Iron Binding Capacity Measurement Islet Cell 512 Antibody Measurement Islet Cell 512 Antigen Measurement Interferon Alpha Measurement Interferon Beta Measurement Interferon Gamma Measurement

C81984 C74863 C74879 C74880 C102275 C96669 C80190 C74612 C92273 C74718 C74719 C81985 C81986 C81994 C81995 C81996

HTPHAB HVA HYDCDN HYDMRPHN HYDROGEN HYPERCHR HYPRLN HYPSEGCE IAH1N1VL IBCT IBCU IC512AB IC512AG IFNA IFNB IFNG

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 189 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Immunoglobulin A Immunoglobulin D Immunoglobulin E Insulin-like Growth Factor-1 Insulin-like Growth Factor-2 Immunoglobulin G Immunoglobulin M Soluble Interleukin 2 Receptor Activity Indican Influenza A Viral Load Islet Neogenesis Assoc Protein Antibody Inhibin A Inhibin B Inulin Clearance

NCI Code C81969 C98745 C81970 C74864 C74865 C81971 C81972 C102280

CDISC Submission Value IGA IGD IGE IGF1 IGF2 IGG IGM IL2SRA

CDISC Definition A measurement of the Immunoglobulin A in a biological specimen. A measurement of the Immunoglobulin D in a biological specimen. A measurement of the Immunoglobulin E in a biological specimen. A measurement of the insulin-like growth factor-1 in a biological specimen. A measurement of the insulin-like growth factor-2 in a biological specimen. A measurement of the Immunoglobulin G in a biological specimen. A measurement of the Immunoglobulin M in a biological specimen. A measurement of the soluble interleukin 2 receptor activity in a biological specimen.

NCI Preferred Term Immunoglobulin A Measurement Immunoglobulin D Measurement Immunoglobulin E Measurement Insulin Like Growth Factor-1 Measurement Insulin Like Growth Factor-2 Measurement Immunoglobulin G Measurement Immunoglobulin M Measurement Soluble Interleukin 2 Receptor Activity Measurement

C82044 C92274 C81987

INDICAN INFAVLD INGAPAB

A measurement of the indican present in a biological specimen. A measurement of the Influenza A viral load in a biological specimen. A measurement of the islet neogenesis associated protein antibody in a biological specimen. A measurement of the inhibin A in a biological specimen. A measurement of the inhibin B in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of inulin by excretion of urine for a specified unit of time (e.g. one minute). A ratio that represents the prothrombin time for a plasma specimen, divided by the result for a control plasma specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test. A measurement of the insulin in a biological specimen. A measurement of the interleukin 1 in a biological specimen. A measurement of the interleukin 10 in a biological specimen. A measurement of the interleukin 11 in a biological specimen. A measurement of the interleukin 12 in a biological specimen.

Indican Measurement Influenza A Viral Load Measurement Islet Neogenesis Associated Protein Antibody Measurement Inhibin A Measurement Inhibin B Measurement Inulin Clearance

C82020 C96681 C98748

INHIBINA INHIBINB INLCLR

C64805

INR

Prothrombin Intl. Normalized Ratio

International Normalized Ratio of Prothrombin Time

C74788 C74805 C74806 C74807 C74808

INSULIN INTLK1 INTLK10 INTLK11 INTLK12

Insulin Interleukin 1 Interleukin 10 Interleukin 11 Interleukin 12

Insulin Measurement Interleukin 1 Measurement Interleukin 10 Measurement Interleukin 11 Measurement Interleukin 12 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 190 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Interleukin 13 Interleukin 14 Interleukin 15 Interleukin 16 Interleukin 17 Interleukin 18 Interleukin 19 Interleukin 2 Interleukin 20 Interleukin 21 Interleukin 22 Interleukin 23 Interleukin 24 Interleukin 25 Interleukin 26 Interleukin 27 Interleukin 28 Interleukin 29 Interleukin 3 Interleukin 30 Interleukin 31 Interleukin 32

NCI Code C74809 C74810 C74811 C74812 C74813 C74814 C74815 C74816 C74817 C74818 C74819 C74820 C74821 C74822 C74823 C74824 C74825 C74826 C74827 C74828 C74829 C74830

CDISC Submission Value INTLK13 INTLK14 INTLK15 INTLK16 INTLK17 INTLK18 INTLK19 INTLK2 INTLK20 INTLK21 INTLK22 INTLK23 INTLK24 INTLK25 INTLK26 INTLK27 INTLK28 INTLK29 INTLK3 INTLK30 INTLK31 INTLK32

CDISC Definition A measurement of the interleukin 13 in a biological specimen. A measurement of the interleukin 14 in a biological specimen. A measurement of the interleukin 15 in a biological specimen. A measurement of the interleukin 16 in a biological specimen. A measurement of the interleukin 17 in a biological specimen. A measurement of the interleukin 18 in a biological specimen. A measurement of the interleukin 19 in a biological specimen. A measurement of the interleukin 2 in a biological specimen. A measurement of the interleukin 20 in a biological specimen. A measurement of the interleukin 21 in a biological specimen. A measurement of the interleukin 22 in a biological specimen. A measurement of the interleukin 23 in a biological specimen. A measurement of the interleukin 24 in a biological specimen. A measurement of the interleukin 25 in a biological specimen. A measurement of the interleukin 26 in a biological specimen. A measurement of the interleukin 27 in a biological specimen. A measurement of the interleukin 28 in a biological specimen. A measurement of the interleukin 29 in a biological specimen. A measurement of the interleukin 3 in a biological specimen. A measurement of the interleukin 30 in a biological specimen. A measurement of the interleukin 31 in a biological specimen. A measurement of the interleukin 32 in a biological specimen.

NCI Preferred Term Interleukin 13 Measurement Interleukin 14 Measurement Interleukin 15 Measurement Interleukin 16 Measurement Interleukin 17 Measurement Interleukin 18 Measurement Interleukin 19 Measurement Interleukin 2 Measurement Interleukin 20 Measurement Interleukin 21 Measurement Interleukin 22 Measurement Interleukin 23 Measurement Interleukin 24 Measurement Interleukin 25 Measurement Interleukin 26 Measurement Interleukin 27 Measurement Interleukin 28 Measurement Interleukin 29 Measurement Interleukin 3 Measurement Interleukin 30 Measurement Interleukin 31 Measurement Interleukin 32 Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 191 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Interleukin 33 Interleukin 4 Interleukin 5 Interleukin 6 Interleukin 7 Interleukin 8 Interleukin 9 Iohexol Clearance Iothalamate Clearance Iothalamate Clearance Adjusted for BSA Immature Reticulocyte Fraction Iron; FE F2-Isoprostane Jo-1 Antibody Potassium Potassium/ Creatinine Ketones Kidney Injury Molecule-1; KIM-1; Hepatitis A Virus Cellular Receptor 1 Kappa Light Chain, Free

NCI Code C74831 C74832 C74833 C74834 C74835 C74836 C74837 C100439

CDISC Submission Value INTLK33 INTLK4 INTLK5 INTLK6 INTLK7 INTLK8 INTLK9 IOHEXCLR

CDISC Definition A measurement of the interleukin 33 in a biological specimen. A measurement of the interleukin 4 in a biological specimen. A measurement of the interleukin 5 in a biological specimen. A measurement of the interleukin 6 in a biological specimen. A measurement of the interleukin 7 in a biological specimen. A measurement of the interleukin 8 in a biological specimen. A measurement of the interleukin 9 in a biological specimen. A measurement of the volume of serum or plasma that would be cleared of Iohexol through excretion for a specified unit of time. A measurement of the volume of serum or plasma that would be cleared of iothalamate by excretion of urine for a specified unit of time (e.g. one minute). A measurement of the volume of serum or plasma that would be cleared of iothalamate by excretion of urine for a specified unit of time (e.g. one minute), adjusted for body size. A measurement of the immature reticulocyte fraction present in a biological specimen. A measurement of the iron in a biological specimen. A measurement of the F2-isoprostane in a biological specimen. A measurement of the Jo-1 antibody in a biological specimen. A measurement of the potassium in a biological specimen. A relative measurement (ratio or percentage) of the potassium to creatinine in a biological specimen. A measurement of the ketones in a biological specimen. A measurement of the kidney injury molecule-1 (Kim-1) in a biological specimen.

NCI Preferred Term Interleukin 33 Measurement Interleukin 4 Measurement Interleukin 5 Measurement Interleukin 6 Measurement Interleukin 7 Measurement Interleukin 8 Measurement Interleukin 9 Measurement Iohexol Clearance

C98749

IOTCLR

Iothalamate Clearance

C98750

IOTCLRBS

Iothalamate Clearance Adjusted for BSA

C102276

IRF

Immature Reticulocyte Fraction Measurement Iron Measurement F2 Isoprostane Measurement Jo-1 Antibody Measurement Potassium Measurement Potassium to Creatinine Ratio Measurement Ketone Measurement Kidney Injury Molecule-1 Measurement

C74679 C80180 C100459 C64853 C79462 C64854 C100433

IRON ISOPRF2 JO1AB K KCREAT KETONES KIM1

C98730

KLCFR

A measurement of the free kappa light chain in a biological specimen.

Free Kappa Light Chain Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 192 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Kappa Lt Chain,Free/ Lambda Lt Chain,Free Megakaryocytes Megakaryocytes/ Total Cells Kurloff Cells

NCI Code C98731

CDISC Submission Value KLCLLCFR

CDISC Definition A relative measurement (ratio or percentage) of the free kappa light chain to the free lambda light chain in a biological specimen. A measurement of the megakaryocytes per unit of a biological specimen. A relative measurement (ratio or percentage) of the megakaryocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the large secretory granule-containing immune cells in a biological specimen taken from members of certain genera of the Caviidae family. A measurement of the lactic acid in a biological specimen. A measurement of the lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 1 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 1 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 2 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 2 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 3 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 3 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 4 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 4 to total lactate dehydrogenase in a biological specimen. A measurement of the lactate dehydrogenase isoenzyme 5 in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase isoenzyme 5 to total lactate dehydrogenase in a biological specimen. A relative measurement (ratio or percentage) of the lactate dehydrogenase to creatinine in a biological specimen. A measurement of the low density lipoprotein cholesterol in a biological specimen.

NCI Preferred Term Free Kappa Light Chain to Free Lambda Light Chain Ratio Measurement Megakaryocyte Count Megakaryocyte to Total CellRatio Measurement Kurloff Cells Measurement

C96688 C98867

KRCYMG KRCYMGCE

C96682

KURLOFCE

C79450

LACTICAC

Lactic Acid; 2-hydroxypropan oic acid; Lactate Lactate Dehydrogenase LDH Isoenzyme 1 LDH Isoenzyme 1/LDH LDH Isoenzyme 2 LDH Isoenzyme 2/LDH LDH Isoenzyme 3 LDH Isoenzyme 3/LDH LDH Isoenzyme 4 LDH Isoenzyme 4/LDH LDH Isoenzyme 5 LDH Isoenzyme 5/LDH Lactate Dehydrogenase/ Creatinine LDL Cholesterol

Lactic Acid Measurement

C64855 C74887 C79451

LDH LDH1 LDH1LDH

Lactate Dehydrogenase Measurement Lactate Dehydrogenase Isoenzyme 1 Measurement LDH Isoenzyme 1 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 2 Measurement LDH Isoenzyme 2 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 3 Measurement LDH Isoenzyme 3 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 4 Measurement LDH Isoenzyme 4 to LDH Ratio Measurement Lactate Dehydrogenase Isoenzyme 5 Measurement LDH Isoenzyme 5 to LDH Ratio Measurement Lactate Dehydrogenase to Creatinine Ratio Measurement Serum LDL Cholesterol Measurement

C74888 C79452

LDH2 LDH2LDH

C74889 C79453

LDH3 LDH3LDH

C74890 C79454

LDH4 LDH4LDH

C74891 C79455

LDH5 LDH5LDH

C79449

LDHCREAT

C61042

LDL

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 193 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Leptin Leukocyte Esterase Large Unstained Cells/ Leukocytes Large Unstained Cells

NCI Code C74866 C64856

CDISC Submission Value LEPTIN LEUKASE

CDISC Definition A measurement of the leptin hormone in a biological specimen. A measurement of the enzyme which indicates the presence of white blood cells in a biological specimen. A relative measure (ratio or percentage) of the large unstained cells to leukocytes in a biological specimen. A measurement of the large, peroxidase-negative cells which cannot be further characterized (i.e. as large lymphocytes, virocytes, or stem cells) present in a biological specimen. A measurement of the luteinizing hormone in a biological specimen. A measurement of the pancreatic lipase in a biological specimen. A measurement of the liver kidney microsomal type 1 antibody in a biological specimen.

NCI Preferred Term Leptin Measurement Leukocyte Esterase Measurement

C79467

LGLUCLE

Large Unstained Cells to Leukocytes Ratio Measurement Large Unstained Cell Count

C74659

LGUNSCE

C74790 C64807 C96683

LH LIPASE LKM1AB

Luteinizing Hormone Triacylglycerol Lipase Liver Kidney Microsomal Type 1 Antibody; LKM-1 Liver Kidney Microsomal Type 1 IgA Ab Liver Kidney Microsomal Type 1 IgG Ab Liver Kidney Microsomal Type 1 IgM Ab Lambda Light Chain, Free Lipoprotein-a Legionella pneumophila Antigen Legionella pneumophila IgG IgM Antibody Legionella pneumophila IgG Antibody

Luteinizing Hormone Measurement Triacylglycerol Lipase Measurement Liver Kidney Microsomal Type 1 Antibody Measurement

C100456

LKM1IAAB

A measurement of the liver kidney microsomal type 1 IgA antibodies in a biological specimen. A measurement of the liver kidney microsomal type 1 IgG antibodies in a biological specimen. A measurement of the liver kidney microsomal type 1 IgM antibodies in a biological specimen. A measurement of the free lambda light chain in a biological specimen. A measurement of the lipoprotein-a in a biological specimen. A measurement of the Legionella pneumophila antigen in a biological specimen. A measurement of the Legionella pneumophila IgG and IgM in a biological specimen. A measurement of the Legionella pneumophila IgG antibody in a biological specimen.

Liver Kidney Microsomal Type 1 IgA Antibody Measurement Liver Kidney Microsomal Type 1 IgG Antibody Measurement Liver Kidney Microsomal Type 1 IgM Antibody Measurement Free Lambda Light Chain Measurement Lipoprotein a Measurement Legionella pneumophila Antigen Measurement Legionella pneumophila IgG IgM Antibody Measurement Legionella pneumophila IgG Antibody Measurement Legionella pneumophila IgM Antibody Measurement Lactoferrin Measurement

C100454

LKM1IGAB

C100455

LKM1IMAB

C98732 C82022 C92275

LLCFR LPA LPNAG

C92277

LPNGMAB

C92276

LPNIGGAB

C92278

LPNIGMAB

Legionella A measurement of the Legionella pneumophila IgM pneumophila IgM antibody in a biological specimen. Antibody Lactoferrin; Lactotransferrin A measurement of the lactoferrin in a biological specimen.

C82021

LTF

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 194 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Lymphocytes Lymphocytes Atypical Lymphocytes Atypical/ Leukocytes Lymphocytes/ Total Cells Immature Lymphocytes Immature Lymphocytes/ Leukocytes Lymphocytes/ Leukocytes Lymphoma Cells Lymphoma Cells/ Lymphocytes Lymphotactin; Chemokine Ligand 1 Plasmacytoid Lymphocytes; Plymphocytes Plasmacytoid Lymphocytes/ Lymphocytes

NCI Code C51949 C64818 C64819

CDISC Submission Value LYM LYMAT LYMATLE

CDISC Definition A measurement of the lymphocytes in a biological specimen. A measurement of the atypical lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the lymphocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the immature lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the immature lymphocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. A measurement of the malignant lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the malignant lymphocytes to all lymphocytes in a biological specimen. A measurement of the lymphotactin in a biological specimen. A measurement of the plasmacytoid lymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) in a biological specimen. A relative measurement (ratio or percentage) of the plasmacytoid lymphocytes (lymphocytes with peripherally clumped chromatin and often deep blue cytoplasm, and that appear similar to plasma cells) to all lymphocytes in a biological specimen. A measurement of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) in a biological specimen. A relative measurement (ratio or percentage) of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) to all lymphocytes in a biological specimen. A measurement of the macrocytes in a biological specimen. A measurement of the May-Hegglin anomaly in a blood sample. This anomaly is characterized by large, misshapen platelets and the presence of Dohle bodies in leukocytes.

NCI Preferred Term Lymphocyte Count Atypical Lymphocyte Count Atypical Lymphocyte To Leukocyte Ratio Lymphocyte to Total Cell Ratio Measurement Immature Lymphocytes Measurement Immature Lymphocytes to Leukocytes Ratio Measurement Lymphocyte To Leukocyte Ratio Lymphoma Cell Count Lymphoma Cell to Lymphocyte Ratio Measurement Lymphotactin Measurement

C98751

LYMCE

C100444 C100443

LYMIM LYMIMLE

C64820 C74613 C74910

LYMLE LYMMCE LYMMCELY

C81955

LYMPHOTC

C74618

LYMPL

Plasmacytoid Lymphocyte Count

C74648

LYMPLLY

Plasmacytoid Lymphocyte to Lymphocyte Ratio Measurement

C74629

LYMRCT

Reactive Lymphocytes Reactive Lymphocytes/ Lymphocytes Macrocytes May-Hegglin Anomaly

Reactive Lymphocyte Count Measurement Reactive Lymphocyte to Lymphocyte Ratio Measurement

C74654

LYMRCTLY

C64821 C74614

MACROCY MAYHEG

Macrocyte Count May-Hegglin Anomaly Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 195 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Ery. Mean Corpuscular Hemoglobin Ery. Mean Corpuscular HGB Concentration Monocyte Chemotactic Protein 1 Monoclonal Immunoglobulin Protein; Paraprotein Macrophage Colony Stimulating Factor Ery. Mean Corpuscular Volume Macrophage-Der ived Chemokine; Chemokine Ligand 22 Metamyelocytes

NCI Code C64797

CDISC Submission Value MCH

CDISC Definition A quantitative measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen. A quantitative measurement of the mean amount of hemoglobin per erythrocytes in a specified volume of a biological specimen. A measurement of the monocyte chemotactic protein 1 in a biological specimen. A measurement of homogenous immunoglobulin resulting from the proliferation of a single clone of plasma cells in a biological specimen. A measurement of the macrophage colony stimulating factor in a biological specimen.

NCI Preferred Term Erythrocyte Mean Corpuscular Hemoglobin Erythrocyte Mean Corpuscular Hemoglobin Concentration

C64798

MCHC

C82025

MCP1

Monocyte Chemotactic Protein 1 Measurement Monoclonal Protein Measurement

C92291

MCPROT

C80191

MCSF

Macrophage Colony Stimulating Factor Measurement

C64799

MCV

A quantitative measurement of the mean volume of erythrocytes in a biological specimen. A measurement of the macrophage-derived chemokine in a biological specimen.

Erythrocyte Mean Corpuscular Volume Macrophage-Derived Chemokine Measurement

C81956

MDC

C74615

METAMY

A measurement of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) in a biological specimen. A relative measurement (ratio or percentage ) of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the metamyelocytes (small, myelocytic neutrophils with an indented nucleus) to all leukocytes in a biological specimen. A measurement of the methamphetamine drug present in a biological specimen. A measurement of the methadone present in a biological specimen. A measurement of the methaqualone present in a biological specimen. A measurement of the magnesium in a biological specimen. A measurement of myoglobin in a biological specimen. A relative measurement (ratio or percentage) of the magnesium to creatinine in a biological specimen.

Metamyelocyte Count

C98754

METAMYCE

Metamyelocytes/ Total Cells

Metamyelocyte to Total Cell Ratio Measurement

C74645

METAMYLE

Metamyelocytes/ Leukocytes

Metamyelocyte to Leukocyte Ratio Measurement

C75348 C74881 C74882 C64840 C79436 C79456

METHAMPH METHDN METHQLDN MG MGB MGCREAT

Methamphetamin e Methadone Methaqualone Magnesium Myoglobin Magnesium/ Creatinine

Methamphetamine Measurement Methadone Measurement Methaqualone Measurement Magnesium Measurement Myoglobin Measurement Magnesium to Creatinine Ratio Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 196 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Microcytes Macrophage Inflammatory Protein 1 Alpha; Chemokine Ligand 3 Macrophage Inflammatory Protein 1 Beta; Chemokine Ligand 4 Melatonin Malignant Cells, NOS Malignant Cells, NOS/Blood Cells Methylmalonic Acid Matrix Metalloproteinas e 1; Interstitial Collagenase Matrix Metalloproteinas e 2; Gelatinase A Matrix Metalloproteinas e 3; Stromelysin 1 Matrix Metalloproteinas e 7; Matrilysin Matrix Metalloproteinas e 8; Neutrophil Collagenase Matrix Metalloproteinas e 9; Gelatinase B Monocytes Monoblasts Monoblasts/ Leukocytes

NCI Code C64822 C82023

CDISC Submission Value MICROCY MIP1A

CDISC Definition A measurement of the microcytes in a biological specimen. A measurement of the macrophage inflammatory protein 1 alpha in a biological specimen.

NCI Preferred Term Microcyte Count Macrophage Inflammatory Protein 1 Alpha Measurement

C82024

MIP1B

A measurement of the macrophage inflammatory protein 1 beta in a biological specimen.

Macrophage Inflammatory Protein 1 Beta Measurement

C74867 C74660 C74643

MLATONIN MLIGCE MLIGCEBC

A measurement of the melatonin hormone in a biological specimen. A measurement of the malignant cells of all types in a biological specimen. A relative measurement (ratio or percentage) of the malignant cells of all types to all blood cells in a biological specimen. A measurement of the methylmalonic acid in a biological specimen. A measurement of the matrix metalloproteinase 1 in a biological specimen.

Melatonin Measurement Malignant Cell Count Malignant Cell to Blood Cell Ratio Measurement Methylmalonic Acid Measurement Matrix Metalloproteinase 1 Measurement

C96690 C80192

MMA MMP1

C80193

MMP2

A measurement of the matrix metalloproteinase 2 in a biological specimen. A measurement of the matrix metalloproteinase 3 in a biological specimen.

Matrix Metalloproteinase 2 Measurement Matrix Metalloproteinase 3 Measurement

C80194

MMP3

C80195

MMP7

A measurement of the matrix metalloproteinase 7 in a biological specimen. A measurement of the matrix metalloproteinase 8 in a biological specimen.

Matrix Metalloproteinase 7 Measurement Matrix Metalloproteinase 8 Measurement

C80196

MMP8

C80197

MMP9

A measurement of the matrix metalloproteinase 9 in a biological specimen. A measurement of the monocytes in a biological specimen. A measurement of the monoblast cells in a biological specimen. A relative measurement (ratio or percentage) of the monoblasts to leukocytes in a biological specimen.

Matrix Metalloproteinase 9 Measurement Monocyte Count Monoblast Count Monoblast to Leukocyte Ratio Measurement

C64823 C74631 C74646

MONO MONOBL MONOBLLE

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 197 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Monocytes/Total Cells Immature Monocytes Immature Monocytes/ Leukocytes Monocytes/ Leukocytes Morphine Mean Platelet Component Myeloperoxidase Myeloperoxidase Antibody Mean Platelet Volume Mucous Threads Myeloblasts Myeloblasts/ Leukocytes Type I Myeloblasts Type II Myeloblasts Type III Myeloblasts Myelocytes Myelocytes/ Total Cells Myelocytes/ Leukocytes Myeloid/ Erythroid Ratio

NCI Code C98872

CDISC Submission Value MONOCE

CDISC Definition A relative measurement (ratio or percentage) of the monocytes to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the immature monocytes in a biological specimen. A relative measurement (ratio or percentage) of immature monocytes to total leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen. A measurement of the morphine present in a biological specimen. A measurement of the mean platelet component (platelet activity) in a blood specimen. A measurement of the myeloperoxidase in a biological specimen. A measurement of the myeloperoxidase antibody in a biological specimen. A measurement of the average size of the platelets present in a blood sample. A measurement of the mucous threads present in a biological specimen. A measurement of the myeloblast cells in a biological specimen. A relative measure (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen. A measurement of type I myeloblast cells per unit of a biological specimen. A measurement of type II myeloblast cells per unit of a biological specimen. A measurement of type III myeloblast cells per unit of a biological specimen. A measurement of the myelocytes in a biological specimen. A relative measurement (ratio or percentage) of the myelocytes to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of myeloid progenitor cells to erythrocyte precursor cells in a biological specimen.

NCI Preferred Term Monocytes to Total CellRatioMeasurement Immature Monocyte Count Immature Monocyte to Leukocyte Ratio Measurement Monocyte To Leukocyte Ratio Morphine Measurement Mean Platelet Component Measurement Myeloperoxidase Measurement Myeloperoxidase Antibody Measurement Mean Platelet Volume Measurement Mucous Thread Measurement Myeloblast Count Myeloblast To Leukocyte Ratio Type I Myeloblasts Measurement Type II Myeloblasts Measurement Type III Myeloblasts Measurement Myelocyte Count Myelocyte to Total CellRatio Measurement Myelocyte To Leukocyte Ratio Myeloid to Erythroid Ratio Measurement

C96676 C96677

MONOIM MONOIMLE

C64824 C74883 C96686 C80198 C92280 C74730 C74721 C74632 C64825 C92283 C92284 C92285 C74662 C98868

MONOLE MORPHINE MPC MPO MPOAB MPV MUCTHR MYBLA MYBLALE MYBLAT1 MYBLAT2 MYBLAT3 MYCY MYCYCE

C64826 C92242

MYCYLE MYPCERPC

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 198 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Mycobacterium tuberculosis IFN Gamma Response Mycobacterium tuberculosis Nucleic Acid Sodium/ Creatinine N-Acetyl Glucosamide; N-Acetyl Glucosamine N-Acetyl Glucosamide/ Creatinine 5 Prime Nucleotidase; 5'-Ribonucleotid e Phosphohydrolas e Neopterin Neutrophils Neutrophils Band Form Neutrophils Band Form/ Leukocytes Neutrophils/ Total Cells Giant Neutrophils Immature Neutrophils Immature Neutrophils/ Leukocytes Neutrophils/ Leukocytes Neutrophilic Metamyelocytes Neutrophilic Myelocytes

NCI Code C92241

CDISC Submission Value MYTBGIR

CDISC Definition A measurement of the amount of interferon gamma that is released when Mycobacterium tuberculosis antigen is incubated with a biological specimen, usually blood. Increased amounts of interferon gamma suggests a prior or existing M. tuberculosis infection. A measurement of the Mycobacterium tuberculosis nucleic acid in a biological specimen. A relative measurement (ratio or percentage) of the sodium to creatinine in a biological specimen. A measurement of N-acetyl glucosamide in a biological specimen.

NCI Preferred Term Mycobacterium tuberculosis Interferon Gamma Response

C92279

MYTBNUAC

Mycobacterium tuberculosis Nucleic Acid Measurement Sodium to Creatinine Ratio Measurement N-Acetyl Glucosamide Measurement

C79464 C79459

NACREAT NAG

C79460

NAGCREAT

A relative measurement (ratio or percentage) of the N-acetyl glucosamide to creatinine in a biological specimen. A measurement of the 5'-nucleotidase in a biological specimen.

N-Acetyl Glucosamide to Creatinine Ratio Measurement 5 Prime Nucleotidase Measurement

C79437

NCTD5P

C80199 C63321 C64830 C64831

NEOPTERN NEUT NEUTB NEUTBLE

A measurement of the neopterin in a biological specimen. A measurement of the neutrophils in a biological specimen. A measurement of the banded neutrophils in a biological specimen. A relative measurement (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the neutrophils to total cells in a biological specimen (for example a bone marrow specimen). A measurement of the giant neutrophils in a biological specimen. A measurement of the total immature neutrophils in a biological specimen. A relative measurement (ratio or percentage) of the immature neutrophils to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen. A measurement of the neutrophilic metamyelocytes in a biological specimen. A measurement of the neutrophilic myelocytes in a biological specimen.

Neopterin Measurement Absolute Neutrophil Count Neutrophil Band Form Count Neutrophil Band Form To Leukocyte Ratio Neutrophil to Total Cell Ratio Measurement Giant Neutrophil Count Immature Neutrophil Count Immature Neutrophils to Leukocytes Ratio Measurement Neutrophil To Leukocyte Ratio Neutrophilic Metamyelocyte Count Neutrophilic Myelocyte Count

C98763

NEUTCE

C96651 C96678 C100442

NEUTGT NEUTIM NEUTIMLE

C64827 C84822 C84823

NEUTLE NEUTMM NEUTMY

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 199 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Neutrophils, Segmented Neutrophils, Segmented/ Leukocytes Vacuolated Neutrophils Neisseria gonorrhoeae Screening Nitrite Natural Killer Cells Noradrenaline; Norepinephrine Non-Prostatic Acid Phosphatase Neuropeptide Y N-telopeptide Type I Collagen N-Telopeptides Type II Collagen N-Telopeptides Occult Blood Opiate Osmolality Osmolarity Osteocalcin Ova and Parasite Oxalate; Ethanedioate Oxygen Capacity

NCI Code C81997 C82045

CDISC Submission Value NEUTSG NEUTSGLE

CDISC Definition A measurement of the segmented neutrophils in a biological specimen. A relative measurement (ratio or percentage) of segmented neutrophils to leukocytes in a biological specimen. A measurement of the neutrophils containing small vacuoles in a biological specimen. Examination of a biological specimen to detect the presence of Neisseria gonorrhoeae. A measurement of the nitrite in a urine specimen. A measurement of the total natural killer cells in a biological specimen. A measurement of the norepinephrine hormone in a biological specimen. A measurement of the non-prostatic acid phosphatase in a biological specimen. A measurement of the neuropeptide Y in a biological specimen. A measurement of the N-telopeptide in a biological specimen. A measurement of the type I collagen N-telopeptides in a biological specimen. A measurement of the type II collagen N-telopeptides in a biological specimen. A measurement of the blood in body products such as a stool sample, not detectable on gross examination. A measurement of any opiate class drug present in a biological specimen. A measurement of the osmoles of solute per unit of biological specimen. A measurement of the osmoles of solute per liter of solution. A measurement of the osteocalcin in a biological specimen. A measurement of the parasites and ova in a biological specimen. A measurement of the oxalate in a biological specimen. A measurement of the maximum amount of oxygen that can be combined chemically with hemoglobin in a volume of blood. A measurement of the oxycodone present in a biological specimen.

NCI Preferred Term Segmented Neutrophil Count Segmented Neutrophil to Leukocyte Ratio Measurement Vacuolated Neutrophil Count Neisseria gonorrhoeae Screening

C74628 C92298

NEUTVAC NGON

C64810 C98762 C74868 C100434

NITRITE NKCE NOREPIN NPAP

Nitrite Measurement Natural Killer Cell Count Noradrenaline Measurement Non-Prostatic Acid Phosphatase Measurement Neuropeptide Y Measurement N-telopeptide Measurement Type I Collagen N-Telopeptide Measurement Type II Collagen N-Telopeptide Measurement Occult Blood Measurement Opiate Measurement Osmolality Measurement Osmolarity Measurement Osteocalcin Measurement Ova and Parasite Measurement Oxalate Measurement Oxygen Capacity Measurement

C74892 C74743 C82039 C82041 C74686 C74796 C74801 C74802 C74744 C100452 C92250 C96614

NPY NTELOP NTXI NTXII OCCBLD OPIATE OSMLTY OSMRTY OSTEOC OVAPARS OXALATE OXYCAP

C74884

OXYCDN

Oxycodone; Oxycontin

Oxycodone Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 200 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Oxygen Saturation Oxytocin; Oxytoxin Procollagen 1 N-Terminal Propeptide; Amino-terminal propeptide of type 1 procollagen; P1NP Aminoterm Type 1 P50 Oxygen Plasminogen Activator Inhibitor-1 Plasminogen Activator Inhibitor-1 AG Prostatic Acid Phosphatase Pregnancy-Assoc iated Plasma Protein-A Pappenheimer Bodies

NCI Code C68032 C74869 C96625

CDISC Submission Value OXYSAT OXYTOCIN P1NP

CDISC Definition A measurement of the oxygen-hemoglobin saturation of a volume of blood. A measurement of the oxytocin hormone in a biological specimen. A measurement of the procollagen 1 N-terminal propeptide in a biological specimen.

NCI Preferred Term Oxygen Saturation Measurement Oxytocin Measurement Procollagen 1 N-Terminal Propeptide Measurement

C102279 C82030

P50OXYGN PAI1

A measurement of the partial pressure of oxygen when hemoglobin is half saturated in a biological specimen. A measurement of the plasminogen activator inhibitor-1 in a biological specimen. A measurement of the plasminogen activator inhibitor-1 antigen in a biological specimen. A measurement of the prostatic acid phosphatase in a biological specimen. A measurement of the pregnancy-associated plasma protein-A in a biological specimen. A measurement of the cells containing Pappenheimer Bodies (violet or blue staining ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. A measurement of the Parvovirus B19 IgG antibody in a biological specimen. A measurement of the Parvovirus B19 IgM antibody in a biological specimen. A measurement of the pressure of carbon dioxide in a biological specimen. A measurement of the phencyclidine present in a biological specimen. A measurement of the range of platelet sizes in a biological specimen. A measurement of the Pelger Huet Anomaly (nuclei of neutrophils and eosinophils appear rod-like, spherical or dumbbell shaped) in a biological specimen. A measurement of the pemphigoid antibodies in a biological specimen.

P50 Oxygen Measurement Plasminogen Activator Inhibitor-1 Measurement Plasminogen Activator Inhibitor-1 Antigen Measurement Prostatic Acid Phosphatase Measurement Pregnancy-Associated Plasma Protein-A Measurement Pappenheimer Body Count

C81989

PAI1AG

C80204 C82031

PAP PAPPA

C74616

PAPPEN

C96617 C96618 C82625 C74694

PB19GGAB PB19GMAB PCO2 PCP

Parvovirus B19 IgG Antibody Parvovirus B19 IgM Antibody Partial Pressure Carbon Dioxide Phencyclidine; Phenylcyclohexy lpiperidine Platelet Distribution Width Pelger Huet Anomaly Pemphigoid Antibodies

Parvovirus B19 IgG Antibody Measurement Parvovirus B19 IgM Antibody Measurement Partial Pressure of Carbon Dioxide Measurement Phencyclidine Measurement

C81962

PDW

Platelet Distribution Width

C74617

PELGERH

Pelger Huet Anomaly Measurement

C81988

PEMAB

Pemphigoid Antibody Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 201 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Pepsinogen Pepsinogen A; PGA Pepsinogen C; PGC Pepsinogen I; PGI Pepsinogen II; PGII Proerythroblast pH Phenothiazine; Dibenzothiazine Phosphate; Phosphorus; Inorganic Phosphate Phosphate/ Creatinine Phospholipid Procollagen Type I Carboxy Term Peptide Platelets Platelet Clumps; PLT Clumps Giant Platelets Platelet Hematocrit; Thrombocytocrit Large Platelets Immature Plasma Cells Immature Plasma Cells/ Lymphocytes Mature Plasma Cells; Plasmacytes

NCI Code C100122 C100469 C100470 C100467 C100468 C100446 C45997 C74695 C64857

CDISC Submission Value PEPSNG PEPSNGA PEPSNGC PEPSNGI PEPSNGII PERTHRBL PH PHENTHZ PHOS

CDISC Definition A measurement of the pepsinogen in a biological specimen. A measurement of the pepsinogen A in a biological specimen. A measurement of the pepsinogen C in a biological specimen. A measurement of the pepsinogen I in a biological specimen. A measurement of the pepsinogen II in a biological specimen. A measurement of the proerythroblasts in a biological specimen. A measure of the acidity or alkalinity of a fluid on a scale of 0 to 14. A measurement of the phenothiazine present in a biological specimen. A measurement of the phosphate in a biological specimen.

NCI Preferred Term Pepsinogen Measurement Pepsinogen A Measurement Pepsinogen C Measurement Pepsinogen I Measurement Pepsinogen II Measurement Proerythroblast Measurement pH Phenothiazine Measurement Phosphate Measurement

C79461 C96623 C82033

PHOSCRT PHOSLPD PICP

A relative measurement (ratio or percentage) of the phosphate to creatinine in a biological specimen. A measurement of the phospholipids in a biological specimen. A measurement of the procollagen-1 carboxy-terminal peptide in a biological specimen. A measurement of the platelets in a biological specimen. A measurement of the platelet clumps in a biological specimen. A measurement of the giant (larger than 7um in diameter) platelets in a biological specimen. A relative measurement (ratio or percentage) of the proportion of the volume of blood taken up by platelets. A measurement of the large (between 4 um and 7um in diameter) platelets in a biological specimen. A measurement of the immature plasma cells in a biological specimen. A relative measurement (ratio or percentage) of immature plasma cells to total lymphocytes in a biological specimen. A measurement of the mature plasma cells (plasmacytes) in a biological specimen.

Phosphate to Creatinine Ratio Measurement Phospholipid Measurement Procollagen Type I Carboxy Terminal Peptide Measurement Platelet Count Platelet Clumps Count Giant Platelet Count Platelet Hematocrit Measurement

C51951 C96624 C74728 C100424

PLAT PLATCLMP PLATGNT PLATHCT

C74729 C96679 C96680

PLATLRG PLSIMCE PLSIMCLY

Large Platelet Count Immature Plasma Cell Count Immature Plasma Cell to Lymphocyte Ratio Measurement Mature Plasma Cell Count

C74661

PLSMCE

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 202 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Plasma Cells/Total Cells

NCI Code C98869

CDISC Submission Value PLSMCECE

CDISC Definition A relative measurement (ratio or percentage) of the mature plasma cells (plasmacytes) to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the mature plasma cells (plasmacytes) to all lymphocytes in a biological specimen. Examination of a biological specimen to detect the presence of any protozoan belonging to the Plasmodium genus. A measurement of the precursor (blast stage) plasma cells (antibody secreting cells derived from B cells via antigen stimulation) in a biological specimen. A relative measurement (ratio or percentage) of the precursor (blast stage) plasma cells (antibody secreting cells derived from B cells via antigen stimulation) to all lymphocytes in a biological specimen. A measurement of the pancreatic polypeptide in a biological specimen. A measurement of the pressure of oxygen in a biological specimen. A measurement of the odd-shaped erythrocytes in a whole blood specimen. A relative measurement (ratio or percentage) of the poikilocytes, or irregularly shaped erythrocytes, to all erythrocytes in a biological specimen. A measurement of the blue-staining characteristic of newly generated erythrocytes. A measurement of the prealbumin in a biological specimen. A relative measurement (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. A measurement of the progesterone hormone in a biological specimen. A measurement of the proinsulin in a biological specimen. A measurement of the prolactin hormone in a biological specimen. A measurement of the prolymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the prolymphocytes to all lymphocytes in a biological specimen. A relative measurement (ratio or percentage) of the promonocytes to all leukocytes in a biological specimen.

NCI Preferred Term Plasma Cell to Total CellRatio Measurement

C74911

PLSMCELY

Mature Plasma Cells/ Lymphocytes Plasmodium

Mature Plasma Cell to Lymphocyte Ratio Measurement Plasmodium Measurement

C100453

PLSMDM

C74619

PLSPCE

Precursor Plasma Cells; Plasmablast Precursor Plasma Cells/ Lymphocytes Pancreatic Polypeptide Partial Pressure Oxygen Poikilocytes Poikilocytes/ Erythrocytes Polychromasia Prealbumin Prolymphocytes/ Leukocytes Progesterone Proinsulin Prolactin Prolymphocytes Prolymphocytes/ Lymphocytes Promonocytes/ Leukocytes

Precursor Plasma Cell Count

C74650

PLSPCELY

Precursor Plasma Cell to Lymphocyte Ratio Measurement

C80201 C71251 C79602 C74649

PNCTPP PO2 POIKILO POIKRBC

Pancreatic Polypeptide Measurement Partial Pressure of Oxygen Measurement Poikilocyte Measurement Poikilocyte to Erythrocyte Ratio Measurement Polychromasia Prealbumin Measurement Prolymphocyte To Leukocyte Ratio

C64803 C100435 C64829

POLYCHR PREALB PRLYMLE

C74791 C81967 C74870 C74620 C74651

PROGEST PROINSUL PROLCTN PROLYM PROLYMLY

Progesterone Measurement Proinsulin Measurement Prolactin Measurement Prolymphocyte Count Prolymphocyte to Lymphocyte Ratio Measurement Promonocyte to Lymphocyte Ratio Measurement

C74652

PROMONLE

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 203 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Promonocytes Promyelocytes Promyelocytes/ Total Cells

NCI Code C74621 C74622 C98773

CDISC Submission Value PROMONO PROMY PROMYCE

CDISC Definition A measurement of the promonocytes in a biological specimen. A measurement of the promyelocytes (immature myelocytes) in a biological specimen. A relative measurement (ratio or percentage) of the promyelocytes (immature myelocytes) to total cells in a biological specimen (for example a bone marrow specimen). A relative measurement (ratio or percentage) of the promyelocytes (immature myelocytes) to all leukocytes in a biological specimen. A measurement of the propoxyphene present in a biological specimen. A measurement of a group of complex organic macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. A relative measurement (ratio or percentage) of the protein to creatinine in a biological specimen. A relative measurement (ratio or percentage) of total proteins to the osmolality of a biological specimen.

NCI Preferred Term Promonocyte Count Promyelocyte Count Promyelocyte to Total Cell Ratio Measurement

C74653

PROMYLE

Promyelocytes/ Leukocytes Propoxyphene Protein

Promyelocyte to Lymphocyte Ratio Measurement Propoxyphene Measurement Total Protein Measurement

C74885 C64858

PROPOX PROT

C79463 C92240

PROTCRT PROTOSML

Protein/ Creatinine Protein/ Osmolality; Protein/ Osmolality Ratio Protein S Prostate Specific Antigen Pseudoephedrine Prothrombin Time Prothrombin Activity Prothrombin Fragments 1 + 2 Parathyroid Hormone, C-Terminal Parathyroid Hormone, Fragmented Parathyroid Hormone, Intact Parathyroid Hormone, Mid-Molecule

Protein to Creatinine Ratio Measurement Protein to Osmolality Ratio Measurement

C100436 C17634 C74696 C62656 C98774 C82034 C81964

PROTS PSA PSDEPHD PT PTA PTF1_2 PTHCT

A measurement of the protein S in a biological specimen. A measurement of the prostate specific antigen in a biological specimen. A measurement of the pseudoephedrine present in a biological specimen. A blood clotting measurement that evaluates the extrinsic pathway of coagulation. A measurement of the biological activity of prothrombin in a biological specimen. A measurement of the prothrombin fragments 1 and 2 in a biological specimen. A measurement of the C-terminal fragment of parathyroid hormone in a biological specimen. A measurement of the fragmented parathyroid hormone in a biological specimen. A measurement of the intact parathyroid hormone in a biological specimen. A measurement of the mid-molecule fragment of parathyroid hormone in a biological specimen.

Protein S Measurement Prostate Specific Antigen Measurement Pseudoephedrine Measurement Prothrombin Time Prothrombin Activity Measurement Prothrombin Fragments 1 and 2 Measurement C-Terminal Parathyroid Hormone Measurement Fragmented Parathyroid Hormone Measurement Intact Parathyroid Hormone Measurement Mid-Molecule Parathyroid Hormone Measurement

C74784

PTHFG

C74789 C81965

PTHI PTHMM

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 204 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Parathyroid Hormone, N-Terminal Pyridinoline Peptide YY; Peptide Tyrosine Tyrosine Reg upon Act Normal T-cell Exprd Secrtd; Chemokine Ligand 5 Erythrocytes; Red Blood Cells Erythrocyte Cell Clumps; Red Blood Cell Clumps; RBC Clumps Erythrocyte Ghosts; RBC Ghosts Erythrocyte Cell Morphology; Red Blood Cell Morphology; RBC Morphology Nucleated Erythrocytes; Nucleated Red Blood Cells Nucleated Erythrocytes/ Leukocytes Nucleated Erythrocytes/ Erythrocytes; Nucleated Red Blood Cells/ Erythrocytes Retinol Binding Protein Erythrocytes Distribution Width Renin; Angiotensinogen ase

NCI Code C81966

CDISC Submission Value PTHNT

CDISC Definition A measurement of the N-terminal fragment of parathyroid hormone in a biological specimen. A measurement of the pyridinoline in a biological specimen. A measurement of the peptide YY in a biological specimen. A measurement of the RANTES (regulated on activation, normally, T-cell expressed, and secreted) chemokine in a biological specimen.

NCI Preferred Term N-Terminal Parathyroid Hormone Measurement Pyridinoline Measurement Peptide YY Measurement

C80211 C80202

PYRIDNLN PYY

C81957

RANTES

Reg upon Act Normal T-cell Exprd Secrtd Measurement

C51946 C92245

RBC RBCCLMP

A measurement of the total erythrocytes in a biological specimen. A measurement of red blood cell clumps in a biological specimen.

Erythrocyte Count Erythrocyte Cell Clumps Measurement

C96605

RBCGHOST

A measurement of the erythrocyte ghosts (erythrocytes in which hemoglobin has been removed through hemolysis) in a biological specimen. An examination or assessment of the form and structure of red blood cells.

Erythrocyte Ghost Count

C92296

RBCMORPH

Erythrocyte Cell Morphology

C74705

RBCNUC

A measurement of the nucleated erythrocytes (large, immature nucleated erythrocytes) in a biological specimen. A relative measurement (ratio or percentage) of nucleated erythrocytes to leukocytes in a biological specimen. A relative measurement (ratio or percentage) of the nucleated erythrocytes (large, immature nucleated erythrocytes) to all erythrocytes in a biological specimen.

Nucleated Red Blood Cell Count

C82046

RBCNUCLE

Nucleated Erythrocyte to Leukocyte Ratio Measurement Nucleated Red Blood Cell to Erythrocyte Ratio Measurement

C74647

RBCNURBC

C100437 C64800

RBP RDW

A measurement of the total retinol binding protein in a biological specimen. A value derived from mean corpuscular volume and the standard deviation of the red blood cell volume in a whole blood specimen. A measurement of the renin in a biological specimen.

Retinol Binding Protein Measurement Erythrocyte Distribution Width Measurement Renin Measurement

C74893

RENIN

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 205 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Resistin HCT Corrected Reticulocytes/ Erythrocytes Reticulocytes Hematocrit Corrected Reticulocytes Reticulocyte Hemoglobin Reticulocytes/ Erythrocytes Rheumatoid Factor Ribonucleoprote in Antibody; RNP Antibody Rouleaux Formation Rapid Plasma Reagin Reptilase Time Triiodothyronine , Reverse Stem Cell Factor; KIT Ligand Schistocytes Sickle Cells/ Erythrocytes Sickle Cells Scl-70 Antibody; Scleroderma-70 Antibody Sorbitol Dehydrogenase Secretin

NCI Code C80205 C102274

CDISC Submission Value RESISTIN RETCRRBC

CDISC Definition A measurement of the resistin in a biological specimen. A relative measurement (ratio or percentage) of the hematocrit corrected reticulocytes to erythrocytes in a biological specimen. A measurement of the reticulocytes in a biological specimen. A measurement of the hematocrit corrected reticulocytes in a biological specimen. A measurement of the amount of hemoglobin in reticulocytes. A relative measurement (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. A measurement of the rheumatoid factor antibody in a biological specimen. A measurement of the ribonucleoprotein antibody in a biological specimen. A measurement of the number of stacking red blood cells within a biological specimen. A measurement of the antibodies produced by cellular damage caused by Treponema pallidum (syphilis) in a biological specimen. A measurement of the time it takes a plasma sample to clot after adding the active enzyme reptilase. A measurement of the reverse triiodothyronine in a biological specimen. A measurement of the stem cell factor in a biological specimen. A measurement of the schistocytes (fragmented red blood cells) in a biological specimen. A relative measurement (ratio or percentage) of the sickle cells (sickle shaped red blood cells) to all erythrocytes in a biological specimen. A measurement of the sickle cells (sickle shaped red blood cells) in a biological specimen. A measurement of the Scl-70 antibody in a biological specimen. A measurement of the sorbitol dehydrogenase in a biological specimen. A measurement of the secretin hormone in a biological specimen.

NCI Preferred Term Resistin Measurement Hematocrit Corrected Reticulocytes to Erythrocytes Ratio Measurement Reticulocyte Count Hematocrit Corrected Reticulocyte Count Reticulocyte Hemoglobin Measurement Reticulocyte To Erythrocyte Ratio Rheumatoid Factor Measurement Ribonucleoprotein Antibody Measurement Rouleaux Formation Count Rapid Plasma Reagin Measurement

C51947 C102273

RETI RETIHCR

C98776 C64828 C74717 C100457

RETIHGB RETIRBC RF RNPAB

C74624 C74716

ROULEAUX RPR

C96628 C81968 C82035

RPTLTIME RT3 SCF

Reptilase Time Measurement Reverse Triiodothyronine Measurement Stem Cell Factor Measurement

C74706 C74656

SCHISTO SCKCERBC

Schistocyte Count Sickle Cell to Erythrocyte Ratio Measurement Sickle Cell Count Scl-70 Antibody Measurement

C74626 C100458

SCKLCE SCL70AB

C79465 C74871

SDH SECRETIN

Sorbitol Dehydrogenase Measurement Secretin Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 206 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Sezary Cells

NCI Code C74625

CDISC Submission Value SEZCE

CDISC Definition A measurement of the Sezary cells (atypical lymphocytes with cerebriform nuclei) in a biological specimen. A relative measurement (ratio or percentage of the Sezary cells (atypical lymphocytes with cerebriform nuclei) to all lymphocytes in a biological specimen. A measurement of the sex hormone binding (globulin) protein in a biological specimen.

NCI Preferred Term Sezary Cell Count

C74655

SEZCELY

Sezary Cells/ Lymphocytes Sex Hormone Binding Globulin; Sex Hormone Binding Protein 6-Monoacetylmo rphine Ro Antibody; Sjogrens SS-A Antibody La Antibody; Sjogrens SS-B Antibody Soluble Transferrin Receptor Smudge Cells; Basket Cells Smith Antibody Sodium Somatotrophin; Growth Hormone Spermatozoa Sperm Motility Specific Gravity Spherocytes

Sezary Cell to Lymphocyte Ratio Measurement Sex Hormone Binding Protein Measurement

C74745

SHBG

C74876 C92236

SIXMAM SJSSAAB

A measurement of the 6-monoacetylmorphine present in a biological specimen. A measurement of the Sjogrens SS-A antibody in a biological specimen. A measurement of the Sjogrens SS-B antibody in a biological specimen. A measurement of the soluble transferrin receptor in a biological specimen. A measurement of the smudge cells (the nuclear remnant of a ruptured white blood cell) in a biological specimen. A measurement of the Smith antibody in a biological specimen. A measurement of the sodium in a biological specimen. A measurement of the somatotrophin (growth) hormone in a biological specimen. A measurement of the spermatozoa cells present in a biological specimen. A measurement of the sperm capable of forward, progressive movement in a semen specimen. A ratio of the density of a fluid to the density of water. A measurement of the spherocytes (small, sphere-shaped red blood cells) in a biological specimen. A measurement of the serotonin hormone in a biological specimen. A measurement of the basophilic stippling in a biological specimen. A measurement of the stomatocytes (red blood cells with an oval or rectangular area of central pallor, producing the appearance of a cell mouth) in a biological specimen.

6-Monoacetylmorphine Measurement Sjogren's SS-A Antibody Measurement Sjogren's SS-B Antibody Measurement Soluble Transferrin Receptor Measurement Smudge Cell Count

C92237

SJSSBAB

C100438

SLTFRNRC

C74627

SMDGCE

C92281 C64809 C80360

SMTHAB SODIUM SOMATRO

Smith Antibody Measurement Sodium Measurement Somatotropin Measurement

C74663 C102281 C64832 C74707

SPERM SPERMMTL SPGRAV SPHERO

Spermatozoa Cell Count Sperm Motility Measurement Specific Gravity Spherocyte Count

C74872 C96567 C74708

SRTONIN STIPBASO STOMCY

Serotonin Basophilic Stippling Stomatocytes

Serotonin Measurement Basophilic Stippling Measurement Stomatocyte Count

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 207 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Streptolysin O Antibody; Antistreptolysin O Soluble Vascular Cell Adhesion Molecule 1 Triiodothyronine ; Total T3 Triiodothyronine , Free; Free T3 Triiodothyronine Uptake Thyroxine; Total T4 Thyroxine, Free; Free T4 Thyroxine Binding Globulin Dacryocytes; Tear Shaped Erythrocytes; Teardrop Cells Testosterone; Total Testosterone Testosterone, Free Transferrin Transferrin Saturation Thrombopoietin Thyroid Antibodies Thyroid Antimicrosomal Antibodies Thyroid Antithyroglobuli n Antibodies Thyroperoxidase; Thyroid Peroxidase

NCI Code C92282

CDISC Submission Value STRPLOAB

CDISC Definition A measurement of Streptolysin O Antibody in a biological specimen.

NCI Preferred Term Streptolysin O Antibody Measurement

C92533

SVCAM1

A measurement of the soluble vascular cell adhesion molecule 1 in a biological specimen. A measurement of the total (free and bound) triiodothyronine in a biological specimen. A measurement of the free triiodothyronine in a biological specimen. A measurement of the binding of triiodothyonine to thyroxine binding globulin protein in a biological specimen. A measurement of the total (free and bound) thyroxine in a biological specimen. A measurement of the free thyroxine in a biological specimen. A measurement of the thyroxine binding globulin protein in a biological specimen. A measurement of dacryocytes in a biological specimen.

Soluble Vascular Cell Adhesion Molecule 1 Triiodothyronine Measurement Free Triiodothyronine Measurement Triiodothyronine Uptake Measurement Total Thyroxine Measurement Free Thyroxine Measurement Thyroxine Binding Globulin Protein Measurement Dacryocyte Analysis

C74747 C74787 C74748

T3 T3FR T3UP

C74794 C74786 C74746 C64801

T4 T4FR TBG TEARDCY

C74793

TESTOS

A measurement of the total (free and bound) testosterone in a biological specimen. A measurement of the free testosterone in a biological specimen. A measurement of the transferrin in a biological specimen. A measurement of the iron bound to transferrin in a biological specimen. A measurement of the thrombopoietin hormone in a biological specimen. A measurement of the thyroid antibodies in a biological specimen. A measurement of the thyroid antimicrosomal antibodies in a biological specimen. A measurement of the thyroid antithyroglobulin antibodies in a biological specimen. A measurement of the thyroperoxidase in a biological specimen.

Total Testosterone Measurement

C74785 C82037 C98792 C74873 C81990 C81991

TESTOSFR TFERRIN TFRRNSAT THRMPTN THYAB THYAMAB

Free Testosterone Measurement Transferrin Measurement Transferrin Saturation Measurement Thrombopoietin Measurement Thyroid Antibody Measurement Thyroid Antimicrosomal Antibody Measurement Thyroid Antithyroglobulin Antibody Measurement Thyroperoxidase Measurement

C81992

THYATAB

C96639

THYPXD

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 208 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Thyroperoxidase Antibody Tissue Inhibitor of Metalloproteinas e1 Tumor Necrosis Factor; Tumor Necrosis Factor alpha Toxic Granulation Tissue Plasminogen Activator Antigen Non-Phosphoryl ated Tau Protein Tau Protein; Total Tau Protein Phosphorylated Tau Protein Total Radical-Trap Antioxidant Potential Tricyclic Antidepressants Leptocytes; Target Cells; Codocytes; Mexican Hat Cells Thyrotropin Releasing Hormone; Thyrotropin Releasing Factor Trichomonas

NCI Code C96638 C82036

CDISC Submission Value THYPXDAB TIMP1

CDISC Definition A measurement of the thyroperoxidase antibody in a biological specimen. A measurement of the tissue inhibitor of metalloproteinase 1 in a biological specimen.

NCI Preferred Term Thyroperoxidase Antibody Measurement Tissue Inhibitor of Metalloproteinase 1 Measurement

C74751

TNF

A measurement of the total tumor necrosis factor (cachexin) cytokine in a biological specimen.

Tumor Necrosis Factor Measurement

C96641 C81993

TOXGRAN TPAAG

A measurement of the toxic granulation in neutrophilic blood cells. A measurement of the tissue plasminogen activator antigen in a biological specimen.

Toxic Granulation Measurement Tissue Plasminogen Activator Antigen Measurement

C84811 C84810 C84812 C80208

TPRONP TPROT TPROTP TRAP

A measurement of the non-phosphorylated Tau protein in a biological specimen. A measurement of the total Tau protein in a biological specimen. A measurement of the phosphorylated Tau protein in a biological specimen. A measurement of the ability of the antioxidants in a biological specimen to buffer free radicals in a suspension. A measurement of tricyclic antidepressants in a biological specimen. A measurement of the target cells in a biological specimen.

Nonphosphorylated Tau Protein Measurement Tau Protein Measurement Phosphorylated Tau Protein Measurement Total Radical-Trap Antioxidant Potential Measurement

C100420 C96636

TRCYANDP TRGTCE

Tricyclic Antidepressant Measurement Target Cell Count

C74874

TRH

A measurement of the thyrotropin releasing hormone in a biological specimen.

Thyrotropin Releasing Hormone Measurement

C92238

TRICH

Examination of a biological specimen to detect the presence of any protozoan belonging to the Trichomonas genus. A measurement of the triglycerides in a biological specimen. A measurement of the actin binding troponin in a biological specimen. A measurement of the tropomyosin binding troponin in a biological specimen.

Trichomonas Screening

C64812 C74749 C74750

TRIG TROPONI TROPONT

Triglycerides Troponin I Troponin T

Triglyceride Measurement Troponin I Measurement Troponin T Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 209 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Tryptase Thyrotropin Thrombin Time Turbidity Urate; Uric Acid Urea Urea/Creatinine Urobilinogen Vascular Cell Adhesion Molecule 1 Vascular Endothelial Growth Factor Viscosity Vitamin A; Retinol Thiamine; Vitamin B1 Vitamin B12 Vitamin B17; Amygdalin Riboflavin; Vitamin B2 Niacin; Vitamin B3 Vitamin B5; Pantothenic Acid Vitamin B6; Pyridoxine Vitamin B7; Biotin Folic Acid; Vitamin B9 Vitamin C; Ascorbic Acid

NCI Code C92292 C64813 C80365 C74723 C64814 C64815 C96645 C64816 C82042

CDISC Submission Value TRYPTASE TSH TT TURB URATE UREA UREACRT UROBIL VCAM1

CDISC Definition A measurement of the tryptase in a biological specimen. A measurement of the thyrotropin in a biological specimen. A measurement of the time it takes a plasma sample to clot after adding the active enzyme thrombin. (NCI) A measurement of the opacity of a biological specimen. A measurement of the urate in a biological specimen. A measurement of the urea in a biological specimen. A relative measurement (ratio or percentage) of the urea to creatinine in a biological specimen. A measurement of the urobilinogen in a biological specimen. A measurement of the vascular cell adhesion molecule 1 in a biological specimen. A measurement of the vascular endothelial growth factor in a biological specimen. The resistance of a liquid to sheer forces and flow. (NCI) A measurement of the Vitamin A in a biological specimen. A measurement of the thiamine in a biological specimen. A measurement of the Vitamin B12 in a serum specimen. A measurement of the Vitamin B17 in a biological specimen. A measurement of the riboflavin in a biological specimen. A measurement of the niacin in a biological specimen. A measurement of the Vitamin B5 in a biological specimen. A measurement of the Vitamin B6 in a biological specimen. A measurement of the Vitamin B7 in a biological specimen. A measurement of the folic acid in a biological specimen. A measurement of the Vitamin C in a biological specimen.

NCI Preferred Term Tryptase Measurement Thyrotropin Measurement Thrombin Time Turbidity Measurement Urate Measurement Urea Measurement Urea to Creatinine Ratio Measurement Urobilinogen Measurement Vascular Cell Adhesion Molecule 1 Measurement Vascular Endohelial Growth Factor Measurement Viscosity Vitamin A Measurement Vitamin B1 Measurement Vitamin B12 Measurement Vitamin B17 Measurement Vitamin B2 Measurement Vitamin B3 Measurement Vitamin B5 Measurement Vitamin B6 Measurement Vitamin B7 Measurement Folic Acid Measurement Vitamin C Measurement

C92514

VEGF

C75912 C74895 C74896 C64817 C74897 C74898 C74899 C74900 C74901 C74902 C74676 C74903

VISC VITA VITB1 VITB12 VITB17 VITB2 VITB3 VITB5 VITB6 VITB7 VITB9 VITC

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 210 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Vitamin D; Total Vitamin D Vitamin D2; Ergocalciferol Vitamin D3; Cholecalciferol 1, 25-Dihydroxyvit amin D; Active Vitamin D 25-Hydroxyvita min D; Inactive Vitamin D Vitamin E; Tocopherol Vitamin K; Naphthoquinone VLDL Cholesterol Vanillyl Mandelic Acid; Vanilmandelic Acid Volume Varicella Zoster Virus IgA Antibody Varicella Zoster Virus IgG Antibody Varicella Zoster Virus IgM Antibody Leukocytes; White Blood Cells Leukocyte Cell Clumps; White Blood Cell Clumps; WBC Clumps Leukocyte Cell Morphology; White Blood Cell Morphology; WBC Morphology

NCI Code C84818 C74904 C74905 C92267

CDISC Submission Value VITD VITD2 VITD3 VITDAT

CDISC Definition A measurement of the total Vitamin D in a biological specimen. A measurement of the Vitamin D2 in a biological specimen. A measurement of the Vitamin D3 in a biological specimen. A measurement of the total active Vitamin D in a biological specimen.

NCI Preferred Term Vitamin D Measurement Vitamin D2 Measurement Vitamin D3 Measurement 1, 25-Dihydroxyvitamin D Measurement

C92268

VITDIT

A measurement of the total inactive Vitamin D in a biological specimen. A measurement of the Vitamin E in a biological specimen. A measurement of the Vitamin K in a biological specimen. A measurement of the very low density lipoprotein cholesterol in a biological specimen. A measurement of the vanillyl mandelic acid metabolite in a biological specimen.

25-Hydroxyvitamin D Measurement

C74906 C74907 C64806 C74875

VITE VITK VLDL VMA

Vitamin E Measurement Vitamin K Measurement Serum VLDL Cholesterol Measurement Vanillyl Mandelic Acid Measurement

C74720 C98795

VOLUME VZVIGAAB

A measurement of the volume of a biological specimen. A measurement of the Varicella Zoster virus IgA antibodies in a biological specimen. A measurement of the Varicella Zoster virus IgG antibodies in a biological specimen. A measurement of the Varicella Zoster virus IgM antibodies in a biological specimen. A measurement of the leukocytes in a biological specimen. A measurement of white blood cell clumps in a biological specimen.

Volume Measurement Varicella Zoster Virus IgA Antibody Measurement Varicella Zoster Virus IgG Antibody Measurement Varicella Zoster Virus IgM Antibody Measurement Leukocyte Count

C98796

VZVIGGAB

C98797

VZVIGMAB

C51948

WBC

C92246

WBCCLMP

Leukocyte Cell Clumps Measurement

C92297

WBCMORPH

An examination or assessment of the form and structure of white blood cells.

Leukocyte Cell Morphology

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 211 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C65047 - LBTESTCD - Laboratory Test Code Codelist extensible: Yes
CDISC Synonym Yeast Cells Yeast Hyphae

NCI Code C74664 C92239

CDISC Submission Value YEAST YEASTHYP

CDISC Definition A measurement of the yeast cells present in a biological specimen. Examination of a biological specimen to detect the presence of any yeast cells that are in the long, filamentous and branching phase of growth. A measurement of the zinc in a biological specimen.

NCI Preferred Term Yeast Cell Measurement Yeast Hyphae Screening

C80210

ZINC

Zinc

Zinc Measurement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 212 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101855 - LEADABN - Lead Abnormality Codelist extensible: Yes
CDISC Synonym

NCI Code C99924

CDISC Submission Value CONDUCTOR FAILURE

CDISC Definition Conductor failure manifests by high lead impedance either absolutely (above manufacturer's product specifications) or by a significant increase from previously stable chronic values. The cardiac lead is not performing as expected with issues such as oversensing with or without shock or ATP, or failed shocks or inadequate DFT safety margins defibrillation activity. This manifests as stimulation by the lead of non-cardiac structures such as the diaphragm, chest wall, or pectoral muscle. The cardiac lead failed to administer a shock and had an inadequate defibrillator threshold safety margin. Failure to capture manifests as a high pacing threshold that results in either intermittent failure to capture at maximal programmed output or excessive battery drain leading to premature battery exhaustion. Failure to pace manifests as absence of pacemaker stimulation artifacts on electrocardiographic recordings despite rates below pacemaker programmed rate. Insulation failure manifests as low lead impedance either absolutely (below manufacturer's product specifications) or by a significant decrease from previously stable chronic values. The movement (macroscopic or microscopic) of an existing lead within the heart or vascular tree away from the original implantation site. Oversensing manifests as sensing of electrical signals not related to cardiac depolarization of the lead chamber that cannot be resolved acceptably by device reprogramming. This manifests as sensing of non-cardiac depolarization signals that met arrhythmia detection criteria and elicited programmed tachyarrhythmia therapy. This manifests as sensing of non-cardiac depolarization signals that did not meet arrhythmia detection criteria and do not elicit programmed tachyarrhythmia therapy. The pacing and/or sensing problem associated with high impedance due to a poor connection between a lead and generator caused by a loose set screw. Undersensing manifests as failure to sense appropriate cardiac depolarizations that cannot be resolved with reprogramming.

NCI Preferred Term Cardiac Device Conductor Failure

C99922

DEFIBRILLATION ISSUES

Cardiac Defibrillator Issue

C99951

EXTRACARDIAC STIMULATION FAILED TO SHOCK WITH INADEQUATE DFT SAFETY MARGIN FAILURE TO CAPTURE WITH ACCEPTABLE SAFETY MARGIN FAILURE TO PACE

Extracardiac Stimulation

C99954

Failure to Shock with Inadequate Defibrillator Threshold Safety Margin Failure to Capture with Acceptable Safety Margin

C99953

C99528

Failure of Cardiac Pacemaker to Pace

C99932

INSULATION FAILURE

Cardiac Lead Insulation Failure

C100034

LEAD DISLODGEMENT REQUIRING REPOSITION/ REOPERATION OVERSENSING

Cardiac Lead Dislodgement Requiring Reposition Reoperation

C99926

Cardiac Device Oversensing

C99927

OVERSENSING WITH SHOCK OR ATP

Cardiac Device Oversensing with Shock or Anti-Tachycardia Pacing

C99928

OVERSENSING WITHOUT SHOCK OR ATP

Cardiac Device Oversensing without Shock or Anti-Tachycardia Pacing

C99929

SET SCREW PROBLEM

Cardiac Device Set Screw Problem

C99930

UNDERSENSING

Cardiac Device Undersensing

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 213 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101856 - LEADSTAT - Lead Status Codelist extensible: Yes
CDISC Synonym

NCI Code C99906 C102283 C102284

CDISC Submission Value ABANDONED EXTRACTED REUSED

CDISC Definition The lead has been left in situ but is not in use. The lead has been removed from the body. The lead has been left in situ and reused.

NCI Preferred Term Abandoned Lead Extracted Lead Reused Lead

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 214 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Abdomen; Abdominal Cavity Abdominal Skin

NCI Code C12664

CDISC Submission Value ABDOMINAL CAVITY

CDISC Definition The portion of the body that lies between the thorax and the pelvis. (NCI) The skin or integument surrounding the abdomen. (NCI) The sixth cranial nerve.

NCI Preferred Term Abdominal Cavity

C52758 C12665 C32042

ABDOMINAL SKIN ABDUCENS NERVE ACETABULUM

Abdominal Skin Abducens Nerve Acetabulum

Acetabulum

Two cup shaped areas, one each on the lateral side of the lower pelvis that house the head of the femur to form the ball and socket joint of the hip. (NCI) The junction of the upper distal end of the scapula to the distal edge of the collarbone, also known as the acromion and the clavicle. (NCI) The upper distal process of the scapula. (NCI) The arteries that arise at the junction of the proximal and mid-right coronary artery conduit segments.

C32047

ACROMIOCLAVICULAR JOINT ACROMION ACUTE MARGINAL ARTERY

Acromioclavicul ar Joint Acromion AMARG; ACUTE MARGINAL ARTERY SEGMENT(S) Adrenal Gland

Acromioclavicular Joint

C32048 C102285

Acromion Acute Marginal Artery

C12666

ADRENAL GLAND

Suprarenal gland. A flattened, roughly triangular body resting upon the upper end of each kidney; it is one of the ductless glands furnishing internal secretions (epinephrine and norepinephrine from the medulla and steroid hormones from the cortex). (NCI) An almond-shaped group of basal nuclei anterior to the inferior horn of the lateral ventricle of the brain, within the temporal lobe. The amygdala is part of the limbic system. (MESH) A natural or surgically-induced connection between tubular structures in the body. (NCI) A gliding joint between the distal ends of the tibia and fibula and the proximal end of the talus. (NCI) The initial part of the pyloric canal of the stomach. This site contains endocrine cells that produce gastrin and somatostatin. (NCI) The lower opening of the digestive tract, lying in the cleft between the buttocks, through which fecal matter is extruded. (NCI) The major arterial trunk that carries oxygenated blood from the left ventricle into the ascending aorta behind the heart, the aortic arch, through the thorax as the descending aorta and through the abdomen as the abdominal aorta; it bifurcates into the left and right common iliac arteries. (NCI) The curved section of the aorta between the ascending and the descending tracts. The brachiocephalic, left common carotid and left subclavian arteries branch from the aorta at this section. (NCI) The distal end of the appendix. (NCI)

Adrenal Gland

C12440

AMYGDALA

Amygdaloid Nucleus

Amygdala

C15609 C32078 C12259

ANASTOMOSIS ANKLE JOINT ANTRUM PYLORI

Anastomosis Ankle Joint; Ankle Antrum Pylori

Anastomosis Ankle Joint Antrum Pylori

C43362

ANUS

Anus

Anus

C12669

AORTA

Aorta

Aorta

C32123

AORTIC ARCH

Aortic Arch

Aortic Arch

C83470

APPENDICEAL TIP

Appendiceal Tip

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 215 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Appendix

NCI Code C12380

CDISC Submission Value APPENDIX

CDISC Definition Small tissue projection existing as a cecal diverticulum with a questionable history of vestigial versus specialized organ. (NCI) The portion of the upper extremity between the shoulder and the elbow. For clinical purposes this term is also used to refer to the whole superior limb. (NCI) The skin or integument covering the arm. (NCI) A blood vessel that carries blood away from the heart. (NCI) The underside concavity where the arm and the shoulder are joined. (NCI) An artery that originates from the subclavian artery at the lateral margin of the first rib. It supplies the brachial artery.

NCI Preferred Term Appendix

C32141

ARM

Arm

Arm

C52754 C12372 C12674 C32169

ARM SKIN ARTERY AXILLA AXILLARY ARTERY

Arm Skin Artery Axilla

Arm Skin Artery Axilla Axillary Artery

C12904

AXILLARY LYMPH NODE

Axillary Lymph Node

One of approximately 20-30 lymph nodes in chain formation that traverse the concavity of the underarm to the clavicle. (NCI) A large blood vessel which returns blood to the heart from the lateral thorax, axilla and upper limb. Each side of the body contains one axillary vein.

Axillary Lymph Node

C32171

AXILLARY VEIN

Axillary Vein

C13062 C12447

BACK BASAL GANGLIA

Back Basal Ganglia

The dorsal area between the base of the neck and the sacrum. (NCI) Clusters of neurons comprising the globus pallidus, putamen, caudate, nucleus accumbens, substantia nigra and subthalamic nucleus. They are involved with high level aspects of inhibitory motor activity in coordination with the excitation commands issued from the cerebellum. (NCI) One of the moderately large superficial veins of the forearm that transports blood from the hand and the medial aspect of the forearm to the axillary vein. (NCI) The duct system that transports bile from its origination by hepatocytes in the liver to the small intestine. It is comprised of the common bile duct that connects the liver and gall bladder to the small intestine and the cystic duct that connects the gall bladder to the common bile duct. (NCI) The distensible sac-like organ that functions as a reservoir of urine, collecting from the kidneys and eliminating via the urethra. (NCI) The upper, convex surface of the bladder. (NCI) The portion of the bladder that is formed by the posterior wall and is located opposite to the bladder opening. (NCI) The inferior portion of the urinary bladder which is formed as the walls of the bladder converge and become contiguous with the proximal urethra. (NCI)

Back Basal Ganglia

C32197

BASILIC VEIN

Basilic Vein

Basilic Vein

C12678

BILIARY TRACT

Biliary Tract

Biliary Tract

C12414

BLADDER

Bladder

Bladder

C12332 C48939

BLADDER, DOME BLADDER, FUNDUS

Dome of the Bladder Fundus of the Bladder Neck of the Bladder

Dome of the Bladder Bladder Fundus

C12336

BLADDER, NECK

Bladder Neck

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 216 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Trigone of the Bladder Blood

NCI Code C12331

CDISC Submission Value BLADDER, TRIGONE

CDISC Definition The triangular area in the bladder mucosa that is formed by the two ureteral orifices and the urethral orifice. (NCI) A liquid tissue; its major function is to transport oxygen throughout the body. It also supplies the tissues with nutrients, removes waste products, and contains various components of the immune system defending the body against infection. Several hormones also travel in the blood. (NCI) A tubular structure through which the blood circulates in the body. Blood vessels constitute a network composed of arteries, arterioles, capillaries, venules, and veins. (NCI) The entire physical structure of an organism. It is composed of anatomic systems, regions, cavities, and spaces. (NCI) The main section of the digestive tube that connects the esophagus to the small intestine. The body proper excludes the upper and lower sections of the fundus and pyloric portion respectively. (NCI) Connective tissue that forms the skeletal components of the body. (NCI) The tissue occupying the spaces of bone. It consists of blood vessel sinuses and a network of hematopoietic cells which give rise to the red cells, white cells, and megakaryocytes. (NCI) An artery originating at the axillary artery and branching into the radial and ulnar arteries. (NCI) A nerve network originating from C5 to T1 that supplies cutaneous and muscular innervation to the arm and hand. (NCI) An organ composed of grey and white matter containing billions of neurons that is the center for intelligence and reasoning. It is protected by the bony cranium. (NCI) The part of the brain that connects the cerebral hemispheres with the spinal cord. It consists of the mesencephalon, pons, and medulla oblongata. (NCI) The four connected cavities (hollow spaces) centrally located within the brain that connect posteriorly with the central canal of the spinal cord. (NCI) One of two hemispheric projections of variable size situated in the subcutaneous layer over the pectoralis major muscle on either side of the chest. (NCI) Tubular structure in continuation with the trachea, serving as air passage. It terminates in the lung (terminal bronchiole). (NCI) Either of the fleshy mounds in the rear pelvic area of the human body formed by the gluteal muscles.

NCI Preferred Term Bladder Trigone

C12434

BLOOD

Blood

C12679

BLOOD VESSEL

Blood Vessel

Blood Vessel

C13041

BODY

Body

Body

C12258

BODY OF STOMACH

Body of Stomach

Body of Stomach

C12366 C12431

BONE BONE MARROW

Bone Bone Marrow

Bone Bone Marrow

C12681 C12682

BRACHIAL ARTERY BRACHIAL PLEXUS

Brachial Artery Brachial Plexus

Brachial Artery Brachial Plexus

C12439

BRAIN

Brain; Nervous System, Brain

Brain

C12441

BRAIN STEM

Brain Stem

Brain Stem

C12356

BRAIN VENTRICLE

Brain Ventricle

Brain Ventricle

C12971

BREAST

Breast

Breast

C12683

BRONCHUS

Bronchi; Bronchus Buttock

Bronchus

C89806

BUTTOCK

Buttock

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 217 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym C1 Vertebra C2 Vertebra C3 Vertebra C4 Vertebra C5 Vertebra C6 Vertebra C7 Vertebra

NCI Code C32239 C32240 C32241 C32242 C32243 C32244 C32245 C32252 C32258

CDISC Submission Value C1 VERTEBRA C2 VERTEBRA C3 VERTEBRA C4 VERTEBRA C5 VERTEBRA C6 VERTEBRA C7 VERTEBRA CALCARINE SULCUS CANINE TOOTH

CDISC Definition The first of the seven cervical vertebrae. (NCI) The second of the seven cervical vertebrae. (NCI) The third of the seven cervical vertebrae. (NCI) The fourth of the seven cervical vertebrae. (NCI) The fifth of the seven cervical vertebrae. (NCI) The sixth of the seven cervical vertebrae. (NCI) The seventh of the seven cervical vertebrae. (NCI) A cerebral fissure that originates near the occipital lobe and terminates below the corpus callosum. (NCI)

NCI Preferred Term C1 Vertebra C2 Vertebra C3 Vertebra C4 Vertebra C5 Vertebra C6 Vertebra C7 Vertebra Calcarine Sulcus Canine Tooth

Canine Tooth

A single-cusped (pointed) and usually single-rooted tooth located between the incisors and premolars. (NCI) The largest of eight carpal bones, located in the center of the hand. (NCI) The striated muscle tissue of the heart enveloped by the epicardium and the endocardium. (NCI) One of two arteries that supply oxygenated blood to the head and neck; the left common carotid branches from the aorta and the right common carotid from the innominate (brachiocephalic artery). (NCI) An elongated gray mass of the neostriatum located adjacent to the lateral ventricle of the brain. (MeSH)

C12856 C12371 C12687

CAPITATE BONE CARDIAC MUSCLE TISSUE CAROTID ARTERY

Capitate Bone Myocardium Carotid Artery

Capitate Bone Myocardium Carotid Artery

C12451 C12381

CAUDATE NUCLEUS CECUM Cecal; Cecum

Caudate Nucleus Cecum

A blind pouch-like commencement of the colon in the right lower quadrant of the abdomen at the end of the small intestine and the start of the large intestine. (NCI) A lymph node at the base of the celiac artery. (NCI) The part of the nervous system that consists of the brain, spinal cord, and meninges. (NCI)

C65166 C12438 C32286

CELIAC LYMPH NODE CENTRAL NERVOUS SYSTEM CEPHALIC VEIN

Celiac Lymph Node

Celiac Lymph Node Central Nervous System Cephalic Vein

Cephalic Vein; Vena Cephalica

One of five superficial veins of the upper extremity, beginning at the radial aspect of the wrist area, wrapping around the forearm and emptying into the axillary vein. (NCI) The portion of the brain located at the base of the skull that is responsible for balance, equilibrium and movement. (NCI)

C12445

CEREBELLUM

Cerebellum

C12443

CEREBRAL CORTEX

Cerebral Cortex

The outer layer of the cerebrum composed of neurons and unmyelinated nerve fibers. It is responsible for memory, attention, consciousness and other higher levels of mental function. The layer located below the cerebral cortex that includes the forebrain, midbrain and hindbrain. (NCI)

Cortex

C98712

CEREBRAL SUBCORTEX

Cerebral Subcortex

Cerebral Subcortex

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 218 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Cerebral Hemisphere

NCI Code C12351

CDISC Submission Value CEREBRUM

CDISC Definition One half of the cerebrum, the part of the brain that controls muscle functions and also controls speech, thought, emotions, reading, writing, and learning. The right hemisphere controls the muscles on the left side of the body, and the left hemisphere controls the muscles on the right side of the body. (NCI) Any of the lymph nodes located in the neck. (NCI) Any one of the seven vertebrae that start with C1, connecting the skull to the spine, and ends with C7, which joins the cervical with the thoracic spine. (NCI) The lower part of the uterus occupying the region between the isthmus of the uterus and the vagina. It is divided into supravaginal and vaginal portions. (NCI) The anterior side of the thorax from the neck to the abdomen. The shape of the chest is often regarded as potential insight into a disease process, as in the case of barrel chest and respiratory dysfunction. (NCI) The total system of structures outside the lungs that move as a part of breathing; it includes all structures from the skin to the parietal pleura. (NCI) Blood vessels forming villous structures in the third, fourth, and lateral ventricles of the brain. (NCI) Part of the medial aspect of the cerebral cortex. (NCI)

NCI Preferred Term Cerebral Hemisphere

C32298 C12693

CERVICAL LYMPH NODE CERVICAL VERTEBRA

Cervical Lymph Node Cervical Vertebra Cervix Uteri; Uterine Cervix Chest

Cervical Lymph Node Cervical Vertebra

C12311

CERVIX UTERI

Cervix Uteri

C25389

CHEST

Chest

C62484

CHEST WALL

Chest Wall

Chest Wall

C12694 C52713 C102287

CHOROID PLEXUS CINGULATE CORTEX CIRCUMFLEX ARTERY AV GROOVE CONTINUATION ARTERY

Choroid Plexus

Choroid Plexus Cingulate Cortex Circumflex Artery AV Groove Continuation Artery

CIRC AV; CIRCUMFLEX ARTERY AV GROOVE CONTINUATIO N ARTERY SEGMENT

The segment of the left circumflex artery that is distal to the third marginal branch, located in the atrioventricular groove.

C102286

CIRCUMFLEX, OBTUSE MARGINALS, LEFT POSTEROLETERAL AND LEFT POSTERIOR DESCENDING ARTERY BRANCHES CLAVICLE Clavicle

The left circumflex coronary artery and all of its branches.

Circumflex Artery and its Branches

C12695

One of a pair of bones linking the scapula and the sternum. The clavicle is part of the pectoral girdle. (NCI) Four vertebral segments positioned at the base of the spine that are fused. (NCI) A small bone located at the bottom of the spine. The coccyx is a result of 3-5 fused rudimentary vertebrae. (NCI) The part of the large intestine measured from the cecum to the rectum consisting of ascending, transverse, descending and sigmoid portions. The purpose of the colon is to remove water from digested food prior to excretion. (NCI)

Clavicle

C32334 C12696

COCCYGEAL VERTEBRA COCCYX

Coccygeal Vertebra Coccyx

Coccygeal Vertebra Coccyx

C12382

COLON

Colon

Colon

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 219 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Ascending Colon

NCI Code C12265

CDISC Submission Value COLON, ASCENDING

CDISC Definition The first part of the colon (large intestine) that starts in the right lower quadrant of the abdomen and ends at the transverse colon in the right upper quadrant of the abdomen. (NCI) The fourth portion of the large intestine (colon) that communicates with the transverse colon in the left-upper quadrant of the abdomen and the rectum below. (NCI) The portion of the large intestine that includes the descending and sigmoid colon. (NCI) The proximal segment of the large intestine that is located in the right side of the abdominal cavity. It includes the cecum (with the attached appendix) and the ascending colon. (NCI) The portion of the colon that connects to the descending colon above and the rectum below. (NCI) The third division of the colon (large intestine). It communicates with the ascending colon in the upper right-hand quadrant of the abdomen and the descending colon in the upper left-hand quadrant. (NCI) A thin, transparent tissue divided into the palpebral conjunctiva (covering the inner side of the eye lid) and the bulbar conjunctiva (covering the eyeball). (NCI) A dome-shaped, transparent, avascular tissue covering the front of the eye. It is composed of five layers: squamous epithelium, Bowman's membrane, stroma, Descemet's membrane, and endothelium. Refraction of light contributing to eye's focusing ability is its characteristic function. It contains unmyelinated nerve endings which are responsible for the high sensitivity of the tissue. (NCI) A principal artery that originates in the aorta. It supplies blood to the muscular tissue of the heart. (NCI) A left coronary artery branch that descends on the anterior portion of the heart through the anterior interventricular groove. (NCI) A coronary artery that arises from the aorta and bifurcates into the left anterior descending artery and the left circumflex artery. (NCI)

NCI Preferred Term Ascending Colon

C12268

COLON, DESCENDING

Descending Colon

Descending Colon

C33929 C12383

COLON, LEFT COLON, RIGHT

Left Colon Right Colon

Left Colon Right Colon

C12384 C12385

COLON, SIGMOID COLON, TRANSVERSE

Sigmoid Colon Transverse Colon

Sigmoid Colon Transverse Colon

C12341

CONJUNCTIVA

Conjunctiva

Conjunctiva

C12342

CORNEA

Cornea

Cornea

C12843

CORONARY ARTERY

Coronary Artery

Coronary Artery

C32089

CORONARY ARTERY, ANTERIOR DESCENDING

Anterior Descending Coronary Artery

Anterior Descending Coronary Artery Left Coronary Artery

C12872

CORONARY ARTERY, LEFT Left Coronary Artery; Left Main Coronary Artery; Left Main Coronary Artery Segment; LM CORONARY ARTERY, RIGHT CORONARY SINUS Right Coronary Artery

C12875

A coronary artery that originates above the right coronary cusp and supplies blood predominantly to the right side of the heart. (NCI) The coronary vein that terminates in the right atrium and transports deoxygenated blood from the coronary circulation.

Right Coronary Artery

C32378

Coronary Sinus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 220 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C12882 C26465

CDISC Submission Value CORONARY VEIN CORPUS LUTEUM

CDISC Definition A blood vessel in the heart which returns coronary blood to the right atrium.

NCI Preferred Term Coronary Vein Corpus Luteum

Corpus Luteum

A group of cells that remain of the Graafian follicle following ovulation. This structure is composed of endocrine tissue and produces progesterone. This is needed to prepare the uterine lining for implantation by the fertilized egg. (NCI) The cartilage positioned between the anterior end of the rib and the sternum. Its elasticity allows the ribcage to expand while breathing. (NCI) The first hyaline cartilaginous joint between the ribs and costal cartilage. The seventh hyaline cartilaginous joint between the ribs and costal cartilage.

C32391

COSTAL CARTILAGE

Costal Cartilage

Costal Cartilage

C102288 C102289 C32414

COSTOCHONDRAL JOINT 1 COSTOCHONDRAL JOINT 7 CUBOID BONE Cuboid Bone

Costochondral Joint 1 Costochondral Joint 7 Cuboid Bone

A bone on the lateral side of the tarsus between the calcaneus and the fourth and fifth metatarsal bones. (NCI) Fibromuscular tissue that separates the thoracic from the abdominal cavity. It increases the volume of the thoracic cavity through contractions, thus facilitating respiration.

C12702

DIAPHRAGM

Diaphragm

C102290

DISTAL CIRCUMFLEX ARTERY

DCIRC; DISTAL CIRCUMFLEX ARTERY SEGMENT

The segment of the left circumflex artery that is between the second and third obtuse marginal branches. A condyloid synovial joint within the second digit of the hand connecting the middle and distal phalanges. A condyloid synovial joint within the third digit of the hand connecting the middle and distal phalanges. A condyloid synovial joint within the fourth digit of the hand connecting the middle and distal phalanges. A condyloid synovial joint within the fifth digit of the hand connecting the middle and distal phalanges. The segment of the left anterior descending (LAD) artery that is distal to the third diagonal branch. The section of the right coronary artery distal to the origin of the acute marginal artery.

Distal Circumflex Artery

C102291

DISTAL DIP2 INTERPHALANGEAL JOINT 2 DISTAL DIP3 INTERPHALANGEAL JOINT 3 DISTAL DIP4 INTERPHALANGEAL JOINT 4 DISTAL DIP5 INTERPHALANGEAL JOINT 5 DISTAL LAD ARTERY DLAD; DISTAL LAD ARTERY SEGMENT

Distal Interphalangeal Joint 2

C102292

Distal Interphalangeal Joint 3

C102293

Distal Interphalangeal Joint 4

C102294

Distal Interphalangeal Joint 5

C102295

Distal Left Anterior Descending Artery Distal Right Coronary Artery Conduit

C102296

DISTAL RIGHT CORONARY DRCA; DISTAL ARTERY CONDUIT RIGHT CORONARY ARTERY CONDUIT SEGMENT DORSAL MOTOR NUCLEUS

C12934

A brain nucleus located in the medulla oblongata. (NCI)

Dorsal Motor Nucleus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 221 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Dorsalis Pedis Artery

NCI Code C32478

CDISC Submission Value DORSALIS PEDIS ARTERY

CDISC Definition An artery of the dorsal surface of the foot, originating from the anterior tibial artery of the lower leg. The following arterial branches originate from the dorsalis pedis artery: the arcuate artery of the foot and deep plantar artery. (NCI) A jointed tube 25-30 cm long that connects the stomach to the jejunum. (NCI)

NCI Preferred Term Dorsalis Pedis Artery

C12263 C12394

DUODENUM EAR Ear

Duodenum Ear

A sense organ needed for the detection of sound and for establishing balance. The outer ear consists of the auricle, the ear canal as well as the tympanic membrane. The middle ear is made up of an air-filled cavity behind the tympanic membrane that contains the ossicles (malleus, incus and stapes). The inner ear is made up of the cochlea needed for hearing and the vestibular apparatus required for balance. (NCI) The portion of the ear located within the temporal bone that is involved in both hearing and balance and includes the semicircular canals, vestibule, and cochlea. (from American Heritage Dictionary online) The external part of the ear. (NCI) A type of hinge joint located between the forearm and upper arm. (NCI) The layer of endothelial cells and connective tissue lining the chambers of the heart. (NCI)

C12499

EAR, INNER

Cochlea; Internal Ear; Labyrinth

Internal Ear

C12292 C32497 C13004 C32514 C97338 C13164 C69300 C12328

EAR, OUTER ELBOW JOINT ENDOCARDIUM ENDOMETRIAL CAVITY ENTORHINAL CORTEX EPICARDIUM EPICONDYLE EPIDIDYMIS

Auricle; External Ear Elbow Joint

External Ear Elbow Joint Endocardium Endometrial Cavity Entorhinal Cortex Epicardium Epicondyle Epididymis

Endometrial Cavity

A space inside the uterus lined by a layer of mucus membranes called the endometrium. (NCI) A brain region in the medial temporal lobe near the hippocampus. (NCI) The outer membranous connective tissue layer of the heart tissue. (NCI)

Epicondyle

A bone prominence to which ligaments and tendons of the joints are attached. (NCI) A crescent-like structure located in the upper and posterior surfaces of the testis. It consists of the efferent ductules and the duct of the epididymis. It facilitates the maturation of sperm that is produced in the testis. (NCI)

C12709

EPIGLOTTIS

Epiglottis

A small cartilagenous flap-like valve that closes over the larynx during swallowing to prevent food entering the lungs. (NCI) The portion of the digestive canal between the pharynx and stomach. It is about 25 cm long and consists of three parts: the cervical part, from the cricoid cartilage to the thoracic inlet; thoracic part, from thoracic inlet to the diaphragm; and abdominal part, below the diaphragm to the cardiac opening of the stomach. (NCI)

Epiglottis

C12389

ESOPHAGUS

Esophagus

Esophagus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 222 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Abdominal Esophagus Cervical Esophagus

NCI Code C12252

CDISC Submission Value ESOPHAGUS, ABDOMINAL

CDISC Definition Clinical esophageal segment composed of smooth muscle. It corresponds to the inferior part of the lower third topographic segment of the esophagus. (NCI) Clinical esophageal segment composed of skeletal muscle. It corresponds to the superior part of the upper third topographic segment of the esophagus. (NCI) The lower one third of the esophagus in which the muscle layer is composed of muscle cells predominantly of the smooth type. (NCI) The middle one third of the esophagus in which the muscle layer is composed of muscle cells of the striated and smooth types. Clinical esophageal segment composed of smooth muscle. It includes the middle third topographic segment, as well as parts of the upper and lower thirds. (NCI) The upper one third of esophagus in which the muscle layer is composed of muscle cells of the striated type. (NCI) A light and spongy bone that is cubical in shape. This bone is positioned at the anterior part of the cranium, sitting between the two orbits, at the roof of the nose. It consists of four parts: a horizontal or cribriform plate; a perpendicular plate; and two lateral masses or labyrinths. (NCI) A sinus of the meatuses of the nasal cavity. (NCI) The portion of the biliary tract outside the liver; the common hepatic duct joins the cystic duct to form the common bile duct. (NCI)

NCI Preferred Term Abdominal Esophagus

C12250

ESOPHAGUS, CERVICAL

Cervical Esophagus

C12255

ESOPHAGUS, LOWER THIRD ESOPHAGUS, MIDDLE THIRD ESOPHAGUS, THORACIC

Lower Third of the Esophagus Middle Third of the Esophagus Thoracic Esophagus

Lower Third of the Esophagus

C12254

Middle Third of the Esophagus

C12251

Thoracic Esophagus

C12253

ESOPHAGUS, UPPER THIRD ETHMOID BONE

Upper Third of the Esophagus Ethmoid Bone

Upper Third of the Esophagus

C12711

Ethmoid Bone

C12276 C32573

ETHMOID SINUS EXTRAHEPATIC BILE DUCT

Ethmoid Sinus

Ethmoid Sinus Extrahepatic Bile Duct

C12401 C32576 C12713 C13071

EYE EYELASH EYELID FACE

Eye; Eyeball

The organ of sight or vision. (NCI) Anyone of the short hairs that grow on the edge of the eyelid. (NCI)

Eye Eyelash Eyelid Face

Eyelid; Palpebra Face; Facial

A thin membrane of skin with the purpose of covering and protecting an eye. (NCI) The anterior portion of the head extending from the forehead to the chin and ear to ear. The facial structures contain the eyes, nose and mouth, cheeks and jaws. (NCI) A synovial joint between two adjacent vertebrae. The facet joint links the articular process of one vertebra and the inferior articular process of the adjacent vertebra. (NCI) Any bone that contributes to the facial structures, except those bones that are part of the braincase. (NCI)

C32577

FACET JOINT

Facet Joint

Facet Joint

C63706

FACIAL BONE

Facial Bone

Facial Bone

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 223 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Seventh Cranial Nerve

NCI Code C12714

CDISC Submission Value FACIAL NERVE

CDISC Definition The 7th cranial nerve. The facial nerve has two parts, the larger motor root which may be called the facial nerve proper, and the smaller intermediate or sensory root. Together they provide efferent innervation to the muscles of facial expression and to the lacrimal and salivary glands, and convey afferent information for taste from the anterior two-thirds of the tongue and for touch from the external ear. (MeSH) One of a pair of tubes that extend from the uterus to each of the ovaries. Following ovulation the egg travels down the fallopian tube to the uterus where fertilization may or may not occur. (NCI) Female internal and external organs of reproduction. An artery that starts within the inguinal region and extends to the lower extremities. (NCI) The short, constricted portion of the thigh bone between the femur head and the trochanter. (NCI) A vein that starts within the inguinal region and extends to the lower extremities. (NCI) The upper leg bone positioned between the pelvis and the knee. (NCI) The small, lateral calf bone extending from the knee to the ankle. (NCI) Any of the digits of the hand. (NCI) The nail at the end of a finger. (NCI) The first artery arising from the left anterior descending (LAD) artery that supplies the anterolateral wall, when counted from proximal to distal.

NCI Preferred Term Facial Nerve

C12403

FALLOPIAN TUBE

Fallopian Tube

Fallopian Tube

C61600 C12715 C61563 C12716 C12717 C12718 C32608 C32609 C102297

FEMALE GENITALIA FEMORAL ARTERY FEMORAL NECK FEMORAL VEIN FEMUR FIBULA FINGER FINGERNAIL

Female Genitalia Femoral Artery Femoral Neck Femoral Vein Bone, Femoral; Femur Fibula Finger Fingernail

Female Genitalia Femoral Artery Femoral Neck Femoral Vein Femur Fibula Finger Fingernail First Diagonal Branch Artery

FIRST DIAGONAL BRANCH 1ST DIAG; ARTERY FIRST DIAGONAL BRANCH ARTERY SEGMENT FIRST LEFT POSTEROLATERAL BRANCH ARTERY 1ST LPL; FIRST LEFT POSTEROLATE RAL BRANCH ARTERY SEGMENT 1ST OM; FIRST OBTUSE MARGINAL BRANCH ARTERY SEGMENT 1ST RPL; FIRST RIGHT POSTEROLATE RAL ARTERY SEGMENT Feet; Foot

C102298

In an individual with a left-dominant heart, this is the first branch that arises from the circumflex artery atrioventricular groove continuation when counted from proximal to distal. It supplies the posterolateral wall. The first artery arising from the left circumflex artery that supplies the lateral wall, when counted from proximal to distal.

First Left Posterolateral Branch Artery

C102299

FIRST OBTUSE MARGINAL BRANCH ARTERY

First Obtuse Marginal Branch Artery

C102300

FIRST RIGHT POSTEROLATERAL ARTERY

In an individual with a right-dominant heart, this is the first branch that arises from the right coronary artery distal to the right posterior descending artery, when counted from proximal to distal. The structure found below the ankle joint required for locomotion. (NCI)

First Right Posterolateral Artery

C32622

FOOT

Foot

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 224 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term

NCI CodeCDISC Submission Value C52772 C32628 C40185

FOOT PHALANXFoot PhalanxA bone of the foot. (NCI)Foot Phalanx FOREARMForearmThe structure on the upper limb, between the elbow and the wrist. (NCI) FOREBRAINThe largest part of the brain composed of the cerebral hemispheres, thalamus, hypothalamus, and the limbic system. (NCI) Forearm Forebrain

C89803FOREHEADForeheadThe part of the face between the eyebrows and the normal hairline. C12352 C12277 FRONTAL LOBEFrontal LobeThe part of the brain located anterior to the parietal lobes at the front of each cerebral hemisphere. (NCI) FRONTAL SINUSFrontal SinusThe paired, mucosal lined air spaces located above the orbit and communicating with the nasal passages. (NCI) The portion of the stomach that lies above the cardiac notch. It allows for the accumulation of gases produced by chemical digestion. (NCI)

Forehead Frontal Lobe Frontal Sinus

C12257FUNDUS OF THE STOMACHFundus of the Stomach

Fundus of the Stomach

C12377GALLBLADDERGallbladderA pear-shaped organ located under the liver that stores and concentrates bile secreted by the liver. From the gallbladder the bile is delivered through the bile ducts into the intestine thereby aiding the digestion of fat-containing foods. (NCI) C12719GANGLIONGanglia; Ganglion; Neural Ganglion C13307 C12256 A cluster of nervous tissue principally composed of neuronal cell bodies external to the central nervous system (CNS). (NCI)

Gallbladder

Ganglion

GASTRICGastricRelating to the stomach. (NCI)Gastric GASTRIC CARDIAGastric CardiaThe area around the esophagogastric mucosal junction where the esophageal mucosa transitions into the gastric mucosa. (NCI) Gastroesophagea l Junction Gastrointestinal System Gastrointestinal Tract The anatomical location where the esophagus joins to the stomach. (NCI) The system that includes the esophagus, stomach, small and large intestine, anus, liver, biliary tract, and pancreas. (NCI) The upper gastrointestinal (GI) tract is comprised of mouth, pharynx, esophagus and stomach while the lower GI tract consists of intestines and anus. The primary function of the GI tract is to ingest, digest, absorb and ultimately excrete food stuff. (NCI) The lower part of the gastrointestinal tract that includes the jejunum and ileum of the small intestine and the large intestine. (NCI) The upper part of the gastrointestinal tract that includes the esophagus, stomach, and duodenum. (NCI) Gastric Cardia

C32668GASTROESOPHAGEAL JUNCTION C12378 GASTROINTESTINAL SYSTEM

Gastroesophageal Junction Gastrointestinal System

C34082GASTROINTESTINAL TRACT

Gastrointestinal Tract

C33010GASTROINTESTINAL TRACT, LOWER C33837 GASTROINTESTINAL TRACT, UPPER

Lower Gastrointestinal Tract Upper Gastrointestinal Tract

Lower Gastrointestinal Tract

Upper Gastrointestinal Tract

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Gingiva

NCI CodeCDISC Submission Value C32677

GINGIVAGingiva; GumThe soft tissue surrounding the neck of individual teeth as well as covering the alveolar bone. The tissue is fibrous and continuous with the periodontal ligament and mucosal covering. (NCI) GLENOID FOSSAGlenoid FossaThe trough in the head of the scapula that receives the head of the humerus to form the shoulder joint. (NCI) GLOSSOPHARYNGEAL NERVE The ninth cranial nerve.Glossopharyngeal Nerve

C32682 C12723 C12724 C32698 C12262

Glenoid Fossa

GLOTTISGlottisThe space in which the vocal cords are located. (NCI)Glottis GREAT TROCHANTERGreat TrochanterA large, irregular, quadrilateral area of bone found at the neck of the femur. (NCI) GREATER CURVATURE OF THE STOMACH Greater Curvature of the Stomach The lateral and inferior border of the stomach. Attached to it is the greater omentum. (NCI) Great Trochanter Greater Curvature of the Stomach

C32705HAIRHairThe filamentous outgrowth of the epidermis. (NCI)Hair C32706 C13317 HAIR BULBThe lower segment of the hair that circles the dermal papilla and the hair matrix. (NCI) HAIR FOLLICLEA tube-like invagination of the epidermis from which the hair shaft develops and into which the sebaceous glands open; the follicle is lined by a cellular inner and outer root sheath of epidermal origin and is invested with a fibrous sheath derived from the dermis. (NCI) Hair Bulb Hair Follicle

C32711HAIR ROOTThe portion of the hair that is enclosed within the hair follicle. (NCI) C33543 C12860 C32712 C52771 C12230 C12419 C32720 C12727 HAIR SHAFTShaft of the HairThe segment of the hair that projects above the skin surface. (NCI) HAMATE BONEHamate BoneThe medial bone in the distal row of carpal bones. (NCI) HANDHandThe distal portion of the upper extremity. It consists of the carpus, metacarpus, and digits. (NCI) HAND PHALANXHand PhalanxA bone of the hand. (NCI)Hand Phalanx HARD PALATEHard PalateThe bony anterior part of the roof of the mouth separating the nose from the mouth. (NCI) HEADHeadThe anterior and superior part of a human or animal bearing the mouth, the brain and sensory organs. HEAD OF THE HUMERUSHead of the Humerus The upper rounded part of the humerus that fits into the glenoid cavity of the scapula. (NCI)

Hair Root Shaft of the Hair Hamate Bone Hand

Hard Palate Head Head of the Humerus Heart

HEARTCardiac; HeartA hollow muscular organ which receives the blood from the veins and propels it into the arteries. It is divided by a musculomembranous septum into two halves -- right or venous and left or arterial -- each of which consists of a receiving chamber (atrium) and an ejecting chamber (ventricle). (NCI) HEART, APEXApex of the Heart The most outer superficial part of the heart which is situated on the left 5th intercostal space. (NCI)

C32126

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Cardiac Atrium

NCI Code C12728

CDISC Submission Value HEART, ATRIUM

CDISC Definition The paired upper chambers of the heart. The left atrium receives oxygenated blood from the pulmonary vein and pumps blood into the left ventricle. The right atrium receives venous deoxygenated blood from the entire body via the superior and inferior vena cavae and pumps blood into the right ventricle. (NCI) The superior portion of the heart located opposite to the apical portion. It is formed mainly by the left atrium. (NCI) The left lower chamber of the heart that receives blood from the left atrium and pumps it through the aorta to the body. (NCI) The lower chamber of the heart located in the right side. It receives blood from the right atrium that is no longer oxygenated and it pumps it to the pulmonary artery. (NCI) The tissue in the heart that separates the two atria (atrial septum) and the two ventricles (ventricular septum). (NCI) The lower right and left chambers of the heart. The right pumps venous blood into the lungs and the left pumps oxygenated blood into the systemic arterial circulation. (MeSH) Pertaining to, affecting, or associated with the liver. (NCI) Refers to the area associated with the hilum. (NCI) The lateral prominence of the pelvis from the waist to the thigh. (NCI) A ball-and-socket joint between the head of the femur and the acetabulum. (NCI) A curved gray matter structure of the temporal lobe lying on the floor of the lateral ventricle of the brain. (NCI) The upper arm bone between the shoulder and elbow. (NCI) A U-shaped bone supporting the tongue. This bone is located at the base of the tongue and is suspended from the tips of the styloid processes of the temporal bones by the stylohyoid ligaments. (NCI) The twelfth cranial nerve.

NCI Preferred Term Cardiac Atrium

C48589

HEART, BASE

Base of the Heart

Base of the Heart

C12871

HEART, LEFT VENTRICLE

Left Ventricle

Left Ventricle

C12870

HEART, RIGHT VENTRICLE Right Ventricle

Right Ventricle

C49485

HEART, SEPTUM

Cardiac Septum

Heart Septum

C12730

HEART, VENTRICLE

Cardiac Ventricle

Cardiac Ventricle

C13308 C25724 C64193 C32742 C12444

HEPATIC HILAR HIP HIP JOINT HIPPOCAMPUS

Hepatic Hilar Hip Coxofemoral Joint; Hip Joint Hippocampus

Hepatic Hilar Hip Hip Joint Hippocampus

C12731 C32752

HUMERUS HYOID BONE

Bone, Humeral; Humerus Hyoid Bone

Humerus Hyoid Bone

C12732 C12246 C12458

HYPOGLOSSAL NERVE HYPOPHARYNX HYPOTHALAMUS Hypopharynx Hypothalamus

Hypoglossal Nerve Hypopharynx Hypothalamus

The lower part of the pharynx that connects to the esophagus. (NCI) The supervisory center in the brain, rich in ganglia, nerve fibers, and synaptic connections. It is composed of several sections called nuclei, each of which controls a specific function. The final section of the small intestine. (NCI)

C12387

ILEUM

Ileum

Ileum

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 227 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Terminal Ileum Iliac Lymph Node Ilium

NCI Code C33757 C32761 C32765

CDISC Submission Value ILEUM, TERMINAL ILIAC LYMPH NODE ILIUM

CDISC Definition The most distal section of the ileum that is continuous with the cecum. (NCI) One of the three lymph nodes of the pelvis: the superior gluteal, interior gluteal or sacral. (NCI) The broad, dorsal, upper, and widest of the three principal bones composing either half of the pelvis. (NCI) One of the teeth in front of the canines in either jaw designed for cutting or gnawing. (NCI) One of the three bones comprising the middle ear. This anvil-shaped bone is positioned between the malleus and the stapes. (NCI) A lymph node located in the area below the clavicle. (NCI) A superficial or deep lymph node located in the inguinal area. (NCI) The lower region of the anterior abdominal wall located laterally to the pubic region. (NCI) The blood vessel that supplies the breast and the anterior chest wall with arterial blood. It is located in the chest wall. (NCI) A ginglymoid (hinge) synovial joint within the first digit of the foot connecting the proximal and distal phalanges. A ginglymoid (hinge) synovial joint within the second digit of the foot connecting the proximal and middle phalanges. A ginglymoid (hinge) synovial joint within the third digit of the foot connecting the proximal and middle phalanges. A ginglymoid (hinge) synovial joint within the fourth digit of the foot connecting the proximal and middle phalanges. A ginglymoid (hinge) synovial joint within the fifth digit of the foot connecting the proximal and middle phalanges. The hinge synovial joints between the phalanges of the fingers. (NCI) A condyloid synovial joint within the thumb connecting the proximal and distal phalanges. The portion of the gastrointestinal tract between the stomach and the anus. It includes the small intestine and large intestine. (NCI) The bile ducts that pass through and drain bile from the liver. (NCI)

NCI Preferred Term Terminal Ileum Iliac Lymph Node Ilium

C32769 C32770

INCISOR INCUS

Incisor Incus

Incisor Incus

C63705 C32801 C12726 C52941

INFRACLAVICULAR LYMPH NODE INGUINAL LYMPH NODE INGUINAL REGION INTERNAL MAMMARY ARTERY

Infraclavicular Lymph Node Inguinal Lymph Node Inguinal Region

Infraclavicular Lymph Node Inguinal Lymph Node Inguinal Region Internal Mammary Artery

C102301

INTERPHALANGEAL JOINT IP1 1 INTERPHALANGEAL JOINT IP2 2 INTERPHALANGEAL JOINT IP3 3 INTERPHALANGEAL JOINT IP4 4 INTERPHALANGEAL JOINT IP5 5 INTERPHALANGEAL JOINT Interphalangeal OF THE HAND Joint of the Hand INTERPHALANGEAL THUMB JOINT INTESTINE IP THUMB Intestine

Interphalangeal Joint 1

C102302

Interphalangeal Joint 2

C102303

Interphalangeal Joint 3

C102304

Interphalangeal Joint 4

C102305

Interphalangeal Joint 5

C32868 C102306 C12736

Interphalangeal Joint of the Hand Interphalangeal Thumb Joint Intestine

C12677 C32884

INTRAHEPATIC BILE DUCT ISCHIUM Ischium

Intrahepatic Bile Duct Ischium

The most posterior and ventral bone making up the pelvis. (NCI)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 228 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Jejunum Articulation; Joint

NCI Code C12388 C13044 C12738 C12415

CDISC Submission Value JEJUNUM JOINT JUGULAR VEIN KIDNEY

CDISC Definition The portion of the small intestine that extends from the duodenum to the ileum. (NCI) The connection point between two bones or skeletal elements. The joint may be fixed or movable. (NCI) Veins in the neck which drain the brain, face, and neck into the brachiocephalic or subclavian veins. (NCI)

NCI Preferred Term Jejunum Joint Jugular Vein Kidney

Kidney

One of the two bean-shaped organs located on each side of the spine in the retroperitoneum. The right kidney is located below the liver and the left kidney below the diaphragm. The kidneys filter and secret the metabolic products and minerals from the blood, thus maintaining the homeostasis. On the superior pole of each kidney there is an adrenal gland. Each kidney and adrenal gland is surrounded by fat. (NCI) The outer zone of the KIDNEY, beneath the capsule, consisting of KIDNEY GLOMERULUS; KIDNEY TUBULES, DISTAL; and KIDNEY TUBULES, PROXIMAL. (MSH2001) The concave area of the kidney through which the renal artery enters and the renal vein and ureter exit the organ. (NCI) The lobe of the kidney located in the lowest portion of the kidney. (NCI) The internal portion of the kidney, consisting of striated conical masses, the renal pyramids, whose bases are adjacent to the cortex and whose apices form prominent papillae projecting into the lumen of the minor calyces. (MSH2001) The lobe of the kidney located in the uppermost region of the kidney. (NCI) A joint connecting the lower part of the femur with the upper part of the tibia. The lower part of the femur and the upper part of the tibia are attached to each other by ligaments. Other structures of the knee joint include the upper part of the fibula, located below and parallel to the tibia, and the patella which moves as the knee bends. (NCI) The first lumbar vertebra counting from the top down. (NCI) The second lumbar vertebra counting from the top down. (NCI) The third lumbar vertebra counting from the top down. (NCI) The fourth lumbar vertebra counting from the top down. (NCI) The fifth lumbar vertebra counting from the top down. (NCI)

C12739

KIDNEY, CORTEX

Renal Cortex

Renal Cortex

C32740

KIDNEY, HILUM

Hilar Area of the Kidney Lower Lobe of the Kidney Renal Medulla

Hilar Area of the Kidney

C93180 C12740

KIDNEY, LOWER LOBE KIDNEY, MEDULLA

Lower Lobe of Kidney Renal Medulla

C93179 C32898

KIDNEY, UPPER LOBE KNEE JOINT

Upper Lobe of the Kidney Knee Joint; Tibiofemoral Joint

Upper Lobe of Kidney Knee Joint

C32899 C32900 C32901 C32902 C32903

L1 VERTEBRA L2 VERTEBRA L3 VERTEBRA L4 VERTEBRA L5 VERTEBRA

L1 Vertebra L2 Vertebra L3 Vertebra L4 Vertebra L5 Vertebra

L1 Vertebra L2 Vertebra L3 Vertebra L4 Vertebra L5 Vertebra

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 229 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Lacrimal Bone

NCI Code C32906

CDISC Submission Value LACRIMAL BONE

CDISC Definition A small rectangular thin plate forming part of the medial orbit wall. It is located posterior to the frontal process of the maxilla and articulates with the inferior nasal concha, ethmoid, frontal, and maxillary bones. (NCI) The arteries that arise from the left anterior descending (LAD) artery that supply the interventricular septum.

NCI Preferred Term Lacrimal Bone

C102313

LAD SEPTAL PERFORATOR LAD SP; LAD ARTERY SEPTAL PERFORATOR ARTERY SEGMENTS LARGE INTESTINE LARYNX Large Intestine Larynx

Left Anterior Descending Septal Perforator Artery

C12379 C12420

A muscular tube that extends from the end of the small intestine to the anus. (NCI) The cartilaginous structure of the respiratory tract between the pharynx and the trachea. It contains elastic vocal cords required for sound production. (NCI)

Large Intestine Larynx

C102307

LATERAL FIRST DIAGONAL LAT 1ST DIAG; The lateral branch distal to a bifurcation of the first BRANCH ARTERY LATERAL FIRST diagonal artery. DIAGONAL BRANCH ARTERY SEGMENT LATERAL FIRST OBTUSE MARGINAL BRANCH ARTERY LAT 1ST OM; The lateral branch distal to a bifurcation of the first LATERAL FIRST obtuse marginal artery. OBTUSE MARGINAL BRANCH ARTERY SEGMENT LAT RAMUS; LATERAL RAMUS INTERMEDIUS ARTERY SEGMENT The lateral branch distal to a bifurcation of the ramus intermedius artery.

Lateral First Diagonal Branch Artery

C102308

Lateral First Obtuse Marginal Branch Artery

C102309

LATERAL RAMUS INTERMEDIUS ARTERY

Lateral Ramus Intermedius Artery

C102310

LATERAL SECOND DIAGONAL BRANCH ARTERY

LAT 2ND DIAG; The lateral branch distal to a bifurcation of the second LATERAL diagonal artery. SECOND DIAGONAL BRANCH ARTERY SEGMENT The lateral branch distal to a bifurcation of the second obtuse marginal artery.

Lateral Second Diagonal Branch Artery

C102311

LATERAL SECOND OBTUSE LAT 2ND OM; MARGINAL BRANCH LATERAL ARTERY SECOND OBTUSE MARGINAL BRANCH ARTERY SEGMENT

Lateral Second Obtuse Marginal Branch Artery

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 230 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym LAT 3RD DIAG; LATERAL THIRD DIAGONAL BRANCH ARTERY SEGMENT

NCI Code C102312

CDISC Submission Value LATERAL THIRD DIAGONAL BRANCH ARTERY

CDISC Definition The lateral branch distal to a bifurcation of the third diagonal artery.

NCI Preferred Term Lateral Third Diagonal Branch Artery

C102425

LATERAL THIRD OBTUSE MARGINAL BRANCH ARTERY

LAT 3RD OM; The lateral branch distal to a bifurcation of the third LATERAL obtuse marginal artery. THIRD OBTUSE MARGINAL BRANCH ARTERY SEGMENT LPDA; LEFT POSTEROLATE RAL DESCENDING ARTERY SEGMENT In an individual with a left-dominant heart, this branch arises from the circumflex artery atrioventricular groove continuation and supplies the inferior apex of the heart.

Lateral Third Obtuse Marginal Branch Artery

C102314

LEFT POSTEROLATERAL DESCENDING ARTERY

Left Posterolateral Descending Artery

C102315 C32974 C52749 C12743

LEFT VENTRICULAR EPICARDIUM LEG LEG SKIN LENS Leg Leg Skin Crystalline Lens; Lens; Lens Of Eye; Ocular Lens

The outermost layer of cardiac tissue lining of the left ventricle. One of the two lower extremities in humans used for locomotion and support. (NCI) The skin or integument surrounding the leg. (NCI) A biconvex transparent structure of the eye through which light is focused on the retina. The lens sits behind the iris and is supported by the zonule, which connects it to the ciliary body. The lens is an avascular structure. (NCI) A cone-shaped projection in the shaft of the femur in which the iliopsoas muscle is attached. (NCI) Ligament Band of fibrous tissue connecting bone to bone or cartilage to bone thereby supporting or strengthening a joint. (NCI) A body region referring to an upper or lower extremity. (NCI) The limb that is composed of the hip, thigh, leg and foot. (NCI) The region of the body that includes the arm, the forearm, and hand. (NCI) Fleshy fold which surrounds the opening of the mouth. (NCI) The external surface of the lower lip. (NCI) The external surface of the upper lip. (NCI)

Left Ventricular Epicardium Leg Leg Skin Lens

C32982 C13046

LESSER TROCHANTER LIGAMENT

Lesser Trochanter Ligament

C12429 C12742 C12671 C12220 C12222 C12221

LIMB LIMB, LOWER LIMB, UPPER LIP LIP, LOWER LIP, UPPER

Limb Lower Extremity Upper Extremity Lip External Lower Lip External Upper Lip

Limb Lower Extremity Upper Extremity Lip External Lower Lip External Upper Lip

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 231 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Liver

NCI CodeCDISC Submission Value C12392

LIVERLiverA triangular-shaped organ located under the diaphragm in the right hypochondrium. It is the largest internal organ of the body, weighting up to 2 kg. Metabolism and bile secretion are its main functions. It is composed of cells which have the ability to regenerate. (NCI) LIVER FISSURELiver FissureA groove on the surface of the liver.Liver Fissure LOCUS CERULEUSA brainstem nucleus. It is the major brain site for the synthesis and secretion of norepinephrine. (NCI) LUMBAR VERTEBRALumbar VertebraOne of the five bones situated between the thoracic vertebrae and the sacrum in the lower part of the spine. (NCI)

C32996 C97333 C12744

Locus Coeruleus Lumbar Vertebra

C12786LUNATE BONELunate BoneThe bone in the proximal row of carpal bones that lies between the scaphoid and triquetral bones. (NCI) C12468 LUNGLungOne of a pair of viscera occupying the pulmonary cavities of the thorax, the organs of respiration in which aeration of the blood takes place. As a rule, the right lung is slightly larger than the left and is divided into three lobes (an upper, a middle, and a lower or basal), while the left has two lobes (an upper and a lower or basal). Each lung is irregularly conical in shape, presenting a blunt upper extremity (the apex), a concave base following the curve of the diaphragm, an outer convex surface (costal surface), an inner or mediastinal surface (mediastinal surface), a thin and sharp anterior border, and a thick and rounded posterior border. (NCI) Lung The wedge-shaped area at the central portion of the lung through which the bronchi, vessels and nerves enter or exit the organ. (NCI)

Lunate Bone Lung

C49282LUNG, HILUMHilar Area of the

Hilar Area of the Lung

C32967LUNG, LEFTLeft LungThe 2-lobed lung located on the left side of the body. (NCI) C33020 C33021 LUNG, LEFT LOWER LOBELower Lobe of the Left Lung LUNG, LEFT UPPER LOBEUpper Lobe of the Left Lung The larger lobe of the left lung, situated below and behind the oblique fissure. (NCI) The smaller lobe of the left lung, situated above and in front the oblique fissure, which includes the apex. (NCI)

Left Lung Lower Lobe of the Left Lung Upper Lobe of the Left Lung

C33483LUNG, RIGHTRight LungThe 3-lobed lung located on the right side of the body. (NCI) C33022 C12286 C33023 C12745 LUNG, RIGHT LOWER LOBE LUNG, RIGHT MIDDLE LOBE Lower Lobe of the Right Lung Middle Lobe of the Right Lung The lobe of the right lung situated below the oblique fissure. (NCI) The smallest lobe of the right lung, situated above the oblique fissure and below the horizontal fissure. (NCI) The lobe of the right lung, situated above the horizontal fissure, which includes the apex. (NCI)

Right Lung Lower Lobe of the Right Lung Middle Lobe of the Right Lung Upper Lobe of the Right Lung Lymph Node

LUNG, RIGHT UPPER LOBEUpper Lobe of the Right Lung

LYMPH NODELymph NodeA bean-shaped organ surrounded by a connective tissue capsule. It is part of the lymphatic system and is found through out the body. It is composed predominantly of lymphocytes and its main function is immune protection. (NCI)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


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C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Lymph Node Hilum Left Main Bronchus Right Main Bronchus Male Genitalia Malleus

NCI Code C33031 C32968

CDISC Submission Value LYMPH NODE HILUM MAIN BRONCHUS, LEFT

CDISC Definition The concave side of the lymph node. (NCI) One of the two main bronchi. It is narrower but longer than the right main bronchus and connects to the left lung. (NCI) One of the two main bronchi. It is wider but shorter than the left main bronchus and connects to the right lung. (NCI) Male internal and external organs of reproduction. A hammer-shaped bone, part of three interconnected small bones located in the middle ear. It is attached to the inner surface of the tympanic membrane and its function is to transmit sound vibrations. (NCI) The lower jaw bone holding the lower teeth. (NCI)

NCI Preferred Term Lymph Node Hilum Left Main Bronchus

C33486

MAIN BRONCHUS, RIGHT

Right Main Bronchus

C61599 C33051

MALE GENITALIA MALLEUS

Male Genitalia Malleus

C12290

MANDIBLE

Bone, Mandibular; Mandible; Inferior Maxillary Bone; Jaw Mastoid Process

Mandible

C12503

MASTOID PROCESS

A honeycombed section of bone located near the base of the skull, protruding behind the outer ear. It is connected to the middle ear. (NCI) The upper jawbone in vertebrates: it is fused to the cranium. (NCI) A pyramidal-shaped, thin-walled, air-filled cavity located in the maxilla. It is lined by mucus membrane and periosteum (mucoperiosteum) which contains cilia. It is adjacent to the nasal cavity and communicates with the middle meatus of the nose. It is the largest paranasal sinus and is composed of three recesses: alveolar, zygomatic, and infraorbital. (NCI) A lymph node located in the mediastinum. Mediastinal lymph nodes are arranged in three groups, one on the lateral, another on the medial, and a third on the anterior aspect of the vessels; the third group is, however, sometimes absent. (NCI) A group of organs surrounded by loose connective tissue, separating the two pleural sacs, between the sternum anteriorly and the vertebral column posteriorly as well as from the thoracic inlet superiorly to the diaphragm inferiorly. The mediastinum contains the heart and pericardium, the bases of the great vessels, the trachea and bronchi, esophagus, thymus, lymph nodes, thoracic duct, phrenic and vagus nerves, and other structures and tissues. (NCI) The area between the lungs; it contains the thymus, some lymph nodes, and vessels and branches of the internal thoracic artery. (NCI)

Mastoid Process

C26470 C12275

MAXILLA MAXILLARY SINUS

Maxilla Maxillary Sinus

Maxilla Maxillary Sinus

C33073

MEDIASTINAL LYMPH NODE

Mediastinal Lymph Node

Mediastinal Lymph Node

C12748

MEDIASTINUM

Mediastinum

Mediastinum

C32098

MEDIASTINUM, ANTERIOR Anterior Mediastinum

Anterior Mediastinum

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 233 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Middle Mediastinum Posterior Mediastinum Superior Mediastinum Medulla Oblongata

NCI Code C33123

CDISC Submission Value MEDIASTINUM, MIDDLE

CDISC Definition The broadest part of the lower portion of the mediastinum. It contains the heart and the great vessels. (NCI) The part of the lower portion of the mediastinum that is located behind the pericardium. (NCI) The part of the mediastinum that is located between the upper part of the sternum in the front and the upper thoracic vertebrae in the back. (NCI) The lower portion of the brainstem located between the pons and brainstem. This structure contains several descending and ascending tracts, lower cranial nerve nuclei, a significant proportion of the reticular system of the brainstem and other structures. (NCI) A condyloid synovial joint within the first digit of the hand connecting the metacarpal to the proximal phalanx. A condyloid synovial joint within the second digit of the hand connecting the metacarpal to the proximal phalanx. A condyloid synovial joint within the third digit of the hand connecting the metacarpal to the proximal phalanx. A condyloid synovial joint within the fourth digit of the hand connecting the metacarpal to the proximal phalanx. A condyloid synovial joint within the fifth digit of the hand connecting the metacarpal to the proximal phalanx. A bone belonging to the middle part of the foot located between toes and ankle. There are 5 metatarsal bones and they are numbered from the medial side. (NCI) A spheroid joint located between the heads of the metatarsal bone and the base of the proximal phalanx of the toe. (NCI) A condyloid synovial joint within the first digit of the foot connecting metatarsal with the proximal phalanx. A condyloid synovial joint within the second digit of the foot connecting metatarsal with the proximal phalanx. A condyloid synovial joint within the third digit of the foot connecting metatarsal with the proximal phalanx. A condyloid synovial joint within the fourth digit of the foot connecting metatarsal with the proximal phalanx. A condyloid synovial joint within the fifth digit of the foot connecting metatarsal with the proximal phalanx.

NCI Preferred Term Middle Mediastinum

C33368 C33684

MEDIASTINUM, POSTERIOR MEDIASTINUM, SUPERIOR

Posterior Mediastinum Superior Mediastinum

C12442

MEDULLA OBLONGATA

Medulla Oblongata

C102316

METACARPOPHALANGEAL MCP1 JOINT 1 METACARPOPHALANGEAL MCP2 JOINT 2 METACARPOPHALANGEAL MCP3 JOINT 3 METACARPOPHALANGEAL MCP4 JOINT 4 METACARPOPHALANGEAL MCP5 JOINT 5 METATARSAL BONE Metatarsal Bone

Metacarpophalangeal Joint 1

C102317

Metacarpophalangeal Joint 2

C102318

Metacarpophalangeal Joint 3

C102319

Metacarpophalangeal Joint 4

C102320

Metacarpophalangeal Joint 5

C12752

Metatarsal Bone

C33108

METATARSOPHALANGEAL Metatarsophalan JOINT geal Joint METATARSOPHALANGEAL MTP1 JOINT 1 METATARSOPHALANGEAL MTP2 JOINT 2 METATARSOPHALANGEAL MTP3 JOINT 3 METATARSOPHALANGEAL MTP4 JOINT 4 METATARSOPHALANGEAL MTP5 JOINT 5

Metatarsophalangeal Joint

C102321 C102322

Metatarsophalangeal Joint 1 Metatarsophalangeal Joint 2

C102323 C102324

Metatarsophalangeal Joint 3 Metatarsophalangeal Joint 4

C102325

Metatarsophalangeal Joint 5

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 234 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym MCIRC; MID-CIRCUMF LEX ARTERY SEGMENT MLAD; MID-LAD ARTERY SEGMENT MRCA; MID-RIGHT CORONARY ARTERY CONDUIT SEGMENT

NCI Code C102326

CDISC Submission Value MID-CIRCUMFLEX ARTERY

CDISC Definition The segment of the left circumflex artery between the first and second marginal branches.

NCI Preferred Term Mid-Circumflex Artery

C102328

MID-LAD ARTERY

The segment of the left anterior descending (LAD) artery between the first and third diagonal branches.

Mid-Left Anterior Descending Artery

C102329

MID-RIGHT CORONARY ARTERY CONDUIT

The section of the right coronary artery between the right ventricular artery and the acute marginal artery.

Mid-Right Coronary Artery Conduit

C102327

MID/DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AND ALL DIAGONAL CORONARY BRANCHES MIDBRAIN Mesencephalon; Midbrain

All of the arterial branches distal to the proximal left anterior descending coronary artery.

Mid-Distal Left Anterior Descending Coronary Artery and All Diagonal Coronary Branches

C12510

The uppermost portion of the brainstem located between the pons and the diencephalon. The midbrain contains the cerebral peduncles, oculomotor, trochlear and red nuclei, substantia nigra and various other nuclei and tracts. (NCI) The part of the ear including the eardrum and ossicles. The middle ear leads to the inner ear. (NCI) A brain region that is located in the dorsal part of the precentral gyrus. (NCI)

Mesencephalon

C12274 C97339 C13166 C12435

MIDDLE EAR MOTOR CORTEX MUCOSA MUSCLE TISSUE

Middle Ear

Middle Ear Primary Motor Cortex Mucosa Muscle Tissue

Mucosa Muscle Tissue

Mucous membrane. (NCI) Tissue responsible for the body movements and the shape and size changes of interna organs. Muscle tissue is composed of specialized contractile cells. There are two types of muscle tissue recognized: striated and smooth muscle. The striated muscle tissue is further subdivided into skeletal, visceral striated, and cardiac muscle. (NCI) A muscle located away from the trunk of the body. (NCI) A muscle located close to the trunk of the body. (NCI) The smooth muscle lining the uterus. (NCI) The cutaneous plate on the dorsal surface of the distal end of a finger or toe. (NCI) One of two small oblong bones placed side by side at the middle and upper part of the face. (NCI)

C91405 C91404 C12314 C33156 C33157

MUSCLE TISSUE, DISTAL MUSCLE TISSUE, PROXIMAL MYOMETRIUM NAIL NASAL BONE

Distal Muscle Proximal Muscle Myometrium Nail Nasal Bone

Distal Muscle Proximal Muscle Myometrium Nail Nasal Bone

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 235 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Nasal Cavity

NCI Code C12424

CDISC Submission Value NASAL CAVITY

CDISC Definition The proximal portion of the respiratory passages on either side of the nasal septum lying between the floor of the cranium and the roof of the mouth and extending from the face to the pharynx. The nasal cavity is lined with ciliated mucosa, extending from the nares to the pharynx. (NCI) The thin wall between the two nasal cavities. (NCI) The part of the pharynx in the back of the throat, at and above the soft palate. The nasopharynx is continuous with the nasal passages. (NCI) An oval-shaped bone of the tarsus found on the medial side of the foot. (NCI) The region that connects the head to the rest of the body. (NCI) The pigmented protuberance on the surface of the breast through which milk is drawn from the breast. (NCI) A structure of special sense serving as an organ of the sense of smell and as an entrance to the respiratory tract. (NCI) One of the two channels of the nose, from the point where they divide to the external opening. (NCI) A brain structure that is part of the septal nuclear complex. It is connected with the hippocampus, hypothalamus and amygdala. The posterior part of the cerebral hemisphere. (MeSH) The third cranial nerve.

NCI Preferred Term Nasal Cavity

C33160 C12423

NASAL SEPTUM NASOPHARYNX

Nasal Septum Nasopharynx

Nasal Septum Nasopharynx

C33162 C13063 C12299

NAVICULAR BONE NECK NIPPLE

Navicular Bone Neck Nipple

Navicular Bone Neck Nipple

C12756

NOSE

Nose

Nose

C33178 C97342

NOSTRIL NUCLEUS OF DIAGONAL BAND

Nostril BASAL NUCLEUS/ DIAGONAL BAND

Nostril Nucleus of Diagonal Band

C12355 C12758 C33200 C28401

OCCIPITAL LOBE OCULOMOTOR NERVE OLECRANON OLFACTORY BULB Olecranon Olfactory Bulb

Occipital Lobe Oculomotor Nerve Olecranon Olfactory Bulb

A prominence at the proximal end of the ulna. It forms the tip of the elbow. (NCI) Anatomical structure located in the vertebral forebrain that receives neural input regarding odors that have been detected by cells within the nasal cavity. The axons of olfactory receptor cells extend into the olfactory bulb. (NCI) The part of the nasal mucosa composed of neuroepithelial tissue and mucus-producing Bowman's glands. The mucus moistens the epithelium and helps dissolve odor-containing gases. (NCI) The first cranial nerve.

C33205

OLFACTORY MUCOSA

Olfactory Mucosa

Olfactory Mucosa

C12759 C12761 C12421

OLFACTORY NERVE OPTIC NERVE ORAL CAVITY Optic Nerve Oral Cavity

Olfactory Nerve Optic Nerve Oral Cavity

The second cranial nerve. (NCI) The cavity located at the upper end of the alimentary canal, behind the teeth and gums that is bounded on the outside by the lips, above by the hard and soft palates and below by the tongue. (NCI)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 236 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Eye Socket; Ocular Orbit; Orbit; Orbital Cavity

NCI Code C12347

CDISC Submission Value ORBIT

CDISC Definition The bony cavity of the skull which contains the eye, anterior portion of the optic nerve, ocular muscles and ocular adnexa. Seven bones contribute to the structure of the orbit: the frontal, maxillary, zygomatic, sphenoid, lacrimal, ethmoid, and palatine bones. (NCI) The part of the pharynx between the soft palate and the upper portion of the epiglottis. (NCI) Orbit

NCI Preferred Term

C12762 C12404

OROPHARYNX OVARY Ovary

Oropharynx Ovary

One of the paired female reproductive glands containing the ova or germ cells; the ovary's stroma is a vascular connective tissue containing numbers of ovarian follicles enclosing the ova. (NCI) An irregularly shaped bone positioned at the back part of the nasal cavity between the maxilla and the pterygoid process of the sphenoid. It forms the posterior part of the hard palate and the lateral wall of the nasal fossa and helps to form the floor of the orbit as well as several adjoining parts. (NCI) An organ behind the lower part of the stomach that is the shape of a fish and about the size of a hand. It is a compound gland composed of both exocrine and endocrine tissues. The endocrine pancreas makes insulin so that the body can use glucose (sugar) for energy. The exocrine pancreas makes enzymes that help the body digest food. Spread all over the pancreas are areas called the Islets of Langerhans. The cells in these areas each have a special purpose. The alpha cells make glucagon, which raises the level of glucose in the blood; the beta cells make insulin; the delta cells make somatostatin. There are also PP cells and D1 cells, about which little is known. (NCI) The part of the pancreas from the point where it crosses the portal vein to the point where it enters the lienorenal ligament. (NCI) The pancreatic tissue that contains the islets of Langerhans. It is responsible for the production and secretions of the pancreatic hormones. (NCI) An enzyme producing region of the pancreatic tissue containing the pancreatic acini and exocrine intralobular ducts which collectively secrete the digestive enzymes into the main pancreatic duct to drain into the duodenal part of the small intestine. (NCI) That portion of the pancreas lying in the concavity of the duodenum. (NCI) The left extremity of the pancreas within the lienorenal ligament. (NCI) A lymph node located adjacent to the lumbar region of the spine. (NCI) The subserous connective tissue of the pelvic floor of the supracervical portion of the uterus. The parametrium extends laterally between the layers of the broad ligament. (NCI)

C52745

PALATINE BONE

Palatine Bone

Palatine Bone

C12393

PANCREAS

Pancreas

Pancreas

C12270

PANCREAS, BODY

Body of the Pancreas Endocrine Pancreas Exocrine Pancreas

Body of the Pancreas

C32509

PANCREAS, ENDOCRINE

Endocrine Pancreas

C32546

PANCREAS, EXOCRINE

Exocrine Pancreas

C12269 C12271 C77643 C12320

PANCREAS, HEAD PANCREAS, TAIL PARA-AORTIC LYMPH NODE PARAMETRIUM

Head of the Pancreas Tail of the Pancreas Lymph Node, Para-Aortic Parametrium

Head of the Pancreas Tail of the Pancreas Paraaortic Lymph Node Parametrium

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 237 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Accessory Sinuses; Nasal Cavity; Nasal Sinuses; Paranasal Sinus

NCI Code C12763

CDISC Submission Value PARANASAL SINUS

CDISC Definition An air-filled cavity adjacent to the nasal cavity lined by a mucous membrane and located in the bones of the skull. There are four paranasal sinuses on each side of the face: ethmoid, frontal, maxillary, and sphenoid sinus. (NCI) A usually small autonomic ganglion of the parasympathetic nervous system. The majority are located near or in the organs that they innervate. (NCI) One of two small paired endocrine glands, superior and inferior, usually found embedded in the connective tissue capsule on the posterior surface of the thyroid gland; these glands secrete parathyroid hormone that regulates the metabolism of calcium and phosphorus. The parenchyma is composed of chief and oxyphilic cells arranged in anastomosing cords. (NCI) A cluster of neuronal cell bodies and their dendrites located just ventral and lateral to the spinal cord that give rise to the sympathetic nervous system.

NCI Preferred Term Paranasal Sinus

C52557

PARASYMPATHETIC GANGLIA PARATHYROID GLAND

Parasympathetic Ganglion

C12765

Parathyroid Gland

C97925

PARAVERTEBRAL GANGLIA PARIETAL LOBE Parietal Lobe

Para-Spinal Ganglion

C12354

One of the lobes of the cerebral hemisphere located superiorly to the occipital lobe and posteriorly to the frontal lobe. Cognition and visuospatial processing are its main function. (NCI) The largest of the three paired salivary glands, located in front of the ear. (NCI) A lymph node located close to, on, or within the parotid gland. (NCI) A part of the substantia nigra. The pars compacta nerve cells contain melanin and are involved in motor control. (NCI)

Parietal Lobe

C12427 C33278 C97341

PAROTID GLAND PAROTID GLAND LYMPH NODE PARS COMPACTA

Parotid Gland Parotid Gland Lymph Node

Parotid Gland Parotid Gland Lymph Node Pars Compacta

C33282

PATELLA

Patella

A small flat triangular bone in front of the knee that articulates with the femur and protects the knee joint. (NCI) The caudal portion of the trunk, bounded anteriorly and laterally by the two hip bones incorporating the socket portion of the hip joint for each leg. Posteriorly it is bounded by the sacrum and coccyx. (NCI) Any lymph node within the pelvic region. (NCI) The bony, basin-shaped structure formed by the hipbones and the base of the backbone supporting the lower limbs in humans. (NCI) The male organ of urination and copulation. (NCI) A conical membranous sac filled with serous fluid in which the heart as well as the roots of the aorta and other large blood vessels are contained. (NCI) A lymph node located in the area around the hilum.

Patella

C33287

PELVIC BONE

Pelvic Bone; Pelvis

Pelvic Bone

C12363 C12767

PELVIC LYMPH NODE PELVIS

Pelvic Lymph Node Pelvic Cavity; Pelvis; Pelvic Region Penis Pericardium

Pelvic Lymph Node Pelvis

C12409 C13005

PENIS PERICARDIUM

Penis Pericardium

C102330 C33301

PERIHILAR LYMPH NODE PERINEUM Perineum

Perihilar Lymph Node

The area located between the anus and vulva in females, Perineum and anus and scrotum in males. (NCI)

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 238 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C77642 C12768 C12770

CDISC Submission Value PERIPANCREATIC LYMPH NODE PERIPHERAL NERVE PERITONEUM

CDISC Definition A lymph node of the pancreas. (NCI)

NCI Preferred Term Pancreatic Lymph Node Peripheral Nerve Peritoneum

Peripheral Nerve Peritoneum

Any nerve outside the brain or spinal cord that connects with peripheral receptors or effectors. (NCI) The tissue that lines the wall of the abdominal cavity, intestine, and mesentery. It consists of the parietal peritoneum that covers the inside of the abdominal wall and the visceral peritoneum that covers the surface of the intestine and mesentery. (NCI) A fold of lymphatic tissue covered by ciliated epithelium at the very back of the nose, in the roof of the nasopharynx. (NCI) A hollow tube that starts posterior to the mouth and nasal cavity and ends superior to the trachea and esophagus. (NCI) The medial bone of the proximal row of carpal bones. (NCI) Pea-sized endocrine gland located at the base of the brain in the pituitary fossa. It produces and secretes hormones such as oxytocin and vasopressin, to regulate the activities of the hypothalamus. (NCI) The cavity lined by the pleura, located in the thorax and contains heart and lungs. (NCI) A short thick trunk vein that transports blood containing the absorbed products of digestion from the intestine directly to the liver. (NCI) The arteries arising from the right posterior descending artery that supply the interventricular septum.

C33318

PHARYNGEAL TONSIL

Pharyngeal Tonsil Pharynx

Pharyngeal Tonsil

C12425

PHARYNX

Pharynx

C12855 C12399

PISIFORM BONE PITUITARY GLAND

Pisiform Bone Hypophysis Cerebri; Hypophysis Pleural Cavity Hepatic Portal Vein; Portal Vein PDSP; POSTERIOR DESCENDING SEPTAL PERFORATORS ARTERY SEGMENT

Pisiform Bone Pituitary Gland

C12840 C33343

PLEURAL CAVITY PORTAL VEIN

Pleural Cavity Portal Vein

C102348

POSTERIOR DESCENDING SEPTAL PERFORATORS ARTERY

Septal Perforator Artery

C97340 C12410

PRIMARY VISUAL CORTEX PROSTATE GLAND Prostate Gland

A brain region in the occipital cortex that receives visual stimuli from the retina. (NCI) The walnut shaped accessory sex gland of the male reproductive system. It is located in the pelvis just below the bladder, surrounding the prostatic part of the urethra. The prostate gland secretes a fluid which is part of the semen. (NCI) The prostate gland lobe that is located on the lateral side of the organ. (NCI) The upper, smaller part of the prostate between the ejaculatory ducts and the urethra. (NCI) The prostate gland lobe that is located on the posterior side of the organ. (NCI)

Primary Visual Cortex Prostate Gland

C13092 C13094 C13093

PROSTATE GLAND, LATERAL LOBE PROSTATE GLAND, MIDDLE LOBE PROSTATE GLAND, POSTERIOR LOBE

Lateral Lobe of the Prostate Middle Lobe of the Prostate Posterior Lobe of the Prostate

Lateral Lobe of the Prostate Middle Lobe of the Prostate Posterior Lobe of the Prostate

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 239 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym PCIRC; PROXIMAL CIRCUMFLEX ARTERY SEGMENT

NCI Code C102331

CDISC Submission Value PROXIMAL CIRCUMFLEX ARTERY

CDISC Definition The section of the left circumflex coronary artery that arises from the left main coronary artery and extends to the first marginal branch.

NCI Preferred Term Proximal Circumflex Artery

C102332

PROXIMAL PIP2 INTERPHALANGEAL JOINT 2 PROXIMAL PIP3 INTERPHALANGEAL JOINT 3 PROXIMAL PIP4 INTERPHALANGEAL JOINT 4 PROXIMAL PIP5 INTERPHALANGEAL JOINT 5 PROXIMAL LAD ARTERY PLAD; PROXIMAL LAD ARTERY SEGMENT PRCA; PROXIMAL RIGHT CORONARY ARTERY CONDUIT SEGMENT Putamen

A condyloid synovial joint within the second digit of the hand connecting the proximal and middle phalanges. A condyloid synovial joint within the third digit of the hand connecting the proximal and middle phalanges. A condyloid synovial joint within the fourth digit of the hand connecting the proximal and middle phalanges. A condyloid synovial joint within the fifth digit of the hand connecting the proximal and middle phalanges. The section of the left anterior descending coronary artery that arises from the left main coronary artery and extends to the first diagonal branch. The section of the right coronary artery proximal to the origin of the right ventricular artery.

Proximal Interphalangeal Joint 2

C102333

Proximal Interphalangeal Joint 3

C102334

Proximal Interphalangeal Joint 4

C102335

Proximal Interphalangeal Joint 5

C102336

Proximal Left Anterior Descending Artery

C102337

PROXIMAL RIGHT CORONARY ARTERY CONDUIT

Proximal Right Coronary Artery Conduit

C12452

PUTAMEN

The largest and most lateral of the basal ganglia lying between the lateral medullary lamina of the globus pallidus and the external capsule. It is part of the neostriatum and forms part of the lentiform nucleus along with the globus pallidus. (MeSH) The muscular structure at the distal portion of the stomach, opening into the duodenum. (NCI) The branch of the brachial artery that passes down the forearm. (NCI) The long bone of the forearm that extends from the lateral aspect of the elbow to the thumb-side of the wrist. (NCI) An artery that arises from the left main coronary artery and is positioned between the left anterior descending coronary artery and the circumflex artery.

Putamen

C33433 C12838 C12777

PYLORIC SPHINCTER RADIAL ARTERY RADIUS

Pyloric Sphincter Radial Artery Radius; Radius Bone RAMUS; RAMUS ARTERY; RAMUS INTERMEDIUS ARTERY SEGMENT

Pyloric Sphincter Radial Artery Radius Bone

C102338

RAMUS INTERMEDIUS ARTERY

Ramus Intermedius Artery

C97335

RAPHE

A group of nuclei that are located in the midline of the brainstem and release serotonin. (NCI)

Raphe Nuclei

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 240 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C12390

CDISC Submission Value RECTUM

CDISC Definition The terminal portion of the gastrointestinal tract, extending from the rectosigmoid junction to the anal canal. (NCI)

NCI Preferred Term Rectum

C49018 C12343

REGIONAL LYMPH NODE RETINA

Regional Lymph Node Retina

A lymph node that drains lymph from a region of interest. (NCI) A light-sensitive membrane that lines the back wall of the eyeball. The retina is continuous with the optic nerve and this way transmits optical images to the brain. (NCI) The back of the abdomen where the kidneys lie and the great blood vessels run. (NCI) Any one of the paired bones, 12 on either side, extending from the thoracic vertebrae toward the median line on the ventral aspect of the trunk. The long curved bones which form the rib cage. Generally, ribs 1 to 7 are connected to the sternum' by their costal cartilages and are called true ribs, whereas ribs 8 to 12 are termed false ribs. (NCI) The first rib counting from the top of the rib cage down. (NCI) The tenth rib counting from the top of the rib cage down. (NCI) The eleventh rib counting from the top of the rib cage down. (NCI) The twelfth rib counting from the top of the rib cage down. (NCI) The second rib counting from the top of the rib cage down. (NCI) The third rib counting from the top of the rib cage down. (NCI) The fourth rib counting from the top of the rib cage down. (NCI) The fifth rib counting from the top of the rib cage down. (NCI) The sixth rib counting from the top of the rib cage down. (NCI) The seventh rib counting from the top of the rib cage down. (NCI) The eighth rib counting from the top of the rib cage down. (NCI) The ninth rib counting from the top of the rib cage down. (NCI) The innermost layer of endothelial cells and connective tissue that lines the right atrium.

Regional Lymph Node Retina

C12298 C12782

RETROPERITONEUM RIB

RETROPERITIO NEAL CAVITY Rib

Retroperitoneum Rib

C52770 C52769 C52768 C52767 C52766 C52765 C52764 C52763 C52762 C52761 C52760 C52759 C102339

RIB 1 RIB 10 RIB 11 RIB 12 RIB 2 RIB 3 RIB 4 RIB 5 RIB 6 RIB 7 RIB 8 RIB 9 RIGHT ATRIAL ENDOCARDIUM

Rib 1 Rib 10 Rib 11 Rib 12 Rib 2 Rib 3 Rib 4 Rib 5 Rib 6 Rib 7 Rib 8 Rib 9

Rib 1 Rib 10 Rib 11 Rib 12 Rib 2 Rib 3 Rib 4 Rib 5 Rib 6 Rib 7 Rib 8 Rib 9 Right Atrial Endocardium

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 241 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C102340

CDISC Submission Value RIGHT CORONARY ARTERY, RIGHT POSTERIOR DESCENDING, RIGHT POSTERIOLATERAL AND ACUTE MARGINAL BRANCHES RIGHT POSTERIOR ATRIOVENTRICULAR ARTERY

CDISC Definition The right coronary artery and all of its branches.

NCI Preferred Term Right Coronary Artery and its Branches

C102341

RPAV; RIGHT The arterial branch between the right posterior POSTERIOR descending artery segment and the first right ATRIOVENTRIC posterolateral segment. ULAR ARTERY SEGMENT RPDA; RIGHT POSTERIOR DESCENDING ARTERY SEGMENT In an individual with a right-dominant heart, the arterial branch that arises from the distal right coronary artery between the acute marginal artery and the first right posterolateral segment. It supplies the inferior apex of the heart. The innermost layer of endothelial cells and connective tissue that lines the right ventricle. Sacral Vertebra Sacroiliac Joint Sacrum One of the usually five fused vertebrae forming the triangular bone just below the lumbar vertebrae. (NCI) The joint located between the sacrum and the ilium. (NCI) The triangular bone, made up of 5 fused bones of the spine, located in the lower area of the spine between the fifth lumbar vertebra and the coccyx. (NCI) One of two (Greater, Small) superficial veins of the leg and thigh. (NCI) The skin which covers the top of the head and which is usually covered by hair. (NCI) Scaphoid Bone Scapula; Shoulder Blade Sciatic Nerve A nut-shaped bone of the wrist located in the radial site of the hand. It is one of the eight carpal bones. (NCI) The flat triangle-shaped bone that connects the humerus with the clavicle in the back of the shoulder. (NCI) The longest single nerve that is formed by the merging of the ventral rami of the L4, L5, and S1 in the pelvis and passes down the lower limb where it divides into the common peroneal and tibial nerves. (NCI) The white, opaque, fibrous, outer tunic of the eyeball, covering it entirely excepting the segment covered anteriorly by the cornea. It is essentially avascular but contains apertures for vessels, lymphatics, and nerves. It receives the tendons of insertion of the extraocular muscles and at the corneoscleral junction contains the canal of Schlemm. (From Cline et al., Dictionary of Visual Science, 4th ed) Scrotum The musculocutaneous pouch that encloses the testicles. (NCI)

Right Posterior Atrioventricular Artery

C102342

RIGHT POSTERIOR DESCENDING ARTERY

Right Posterior Descending Artery

C102343 C12853 C33507 C33508

RIGHT VENTRICULAR ENDOCARDIUM SACRAL VERTEBRA SACROILIAC JOINT SACRUM

Right Ventricular Endocardium Sacral Vertebra Sacroiliac Joint Sacrum

C33511 C89807 C12854 C12783

SAPHENOUS VEIN SCALP SCAPHOID BONE SCAPULA

Saphenous Vein

Saphenous Vein Scalp Scaphoid Bone Scapula

C52810

SCIATIC NERVE

Sciatic Nerve

C12784

SCLERA

Sclera

C12785

SCROTUM

Scrotum

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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym 2ND DIAG; SECOND DIAGONAL BRANCH ARTERY SEGMENT 2ND LPL; SECOND LEFT POSTEROLATE RAL BRANCH ARTERY SEGMENT 2ND OM; SECOND OBTUSE MARGINAL BRANCH ARTERY SEGMENT 2ND RPL; SECOND RIGHT POSTEROLATE RAL ARTERY SEGMENT Seminal Sacs

NCI Code C102344

CDISC Submission Value SECOND DIAGONAL BRANCH ARTERY

CDISC Definition The second artery arising from the left anterior descending (LAD) artery that supplies the anterolateral wall, when counted from proximal to distal.

NCI Preferred Term Second Diagonal Branch Artery

C102345

SECOND LEFT POSTEROLATERAL BRANCH ARTERY

In an individual with a left-dominant heart, this is the second branch that arises from the circumflex artery atrioventricular groove continuation when counted from proximal to distal. It supplies the posterolateral wall. The second artery arising from the left circumflex artery that supplies the lateral wall, when counted from proximal to distal.

Second Left Posterolateral Branch Artery

C102346

SECOND OBTUSE MARGINAL BRANCH ARTERY

Second Obtuse Marginal Branch Artery

C102347

SECOND RIGHT POSTEROLATERAL ARTERY

In an individual with a right-dominant heart, this is the second branch that arises from the right coronary artery distal to the right posterior descending artery, when counted from proximal to distal. One of the two paired glands in the male genitourinary system, posterior to the bladder and superior to the prostate gland, that produces fructose-rich seminal fluid which is a component of semen. These glands join the ipsilateral ductus deferens to form the ejaculatory duct. (NCI) The region of the body between the neck and the upper arm. (NCI) A ball-and-socket joint at the upper end of the humerus, located at the junction of humerus and scapula. (NCI) A recess, cavity, or channel. (NCI) Striated muscles that are under voluntary control of the organism. They are connected at either or both ends to a bone and are utilized for locomotion and other movements. (NCI) An organ that constitutes the external surface of the body. It consists of the epidermis, dermis, and skin appendages. (NCI) The skin or integument surrounding the trunk of the body. (NCI) The bones that form the head, made up of the bones of the braincase and face. (NCI)

Second Right Posterolateral Artery

C12787

SEMINAL VESICLE

Seminal Vesicle

C25203 C33548

SHOULDER SHOULDER JOINT

Shoulder Shoulder Joint

Shoulder Shoulder Joint

C33556 C13050

SINUS SKELETAL MUSCLE TISSUE

Sinus Skeletal Muscle Tissue

Sinus Skeletal Muscle Tissue

C12470

SKIN

Integument; Skin

Skin

C12295 C12789

SKIN OF THE TRUNK SKULL

Skin of the Trunk Bone, Cranial; Cranium; Skull

Skin of the Trunk Skull

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 243 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term Small Intestine

NCI CodeCDISC Submission Value C12386

SMALL INTESTINESmall IntestineThe section of the intestines between the pylorus and cecum. The small intestine is approximately 20 feet long and consists of the duodenum, the jejunum, and the ileum. Its main function is to absorb nutrients from food as the food is transported to the large intestine. (NCI) SMOOTH MUSCLE TISSUEInvoluntary muscle tissue of the internal organs. It is composed of elongated muscle cells or fibers that are not arranged in a striated pattern and form layers of muscle tissue. The smooth muscle cells contain a contractile apparatus composed of thin and thick filaments and a cytoskeleton composed of intermediate filaments. (NCI)

C12437

Smooth Muscle Tissue

C12231SOFT PALATEA movable fold suspended from the posterior border of the hard palate. (MeSH) C12471 C32041 SOFT TISSUESoft TissueRefers to muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body. SPINAL ACCESSORY NERVE ACCESSORY NERVE; CRANIAL ACCESSORY NERVE The eleventh cranial nerve.

Soft Palate Soft Tissue Accessory Nerve

C12464

SPINAL CORDMedulla SpinalisThe elongated, approximately cylindrical part of the central nervous system of vertebrates that lies in the vertebral canal and from which the spinal nerves emerge. (NCI) SPLEENSpleenAn organ that is part of the hematopoietic and immune systems. It is composed of the white pulp and the red pulp and is surrounded by a capsule. It is located in the left hypochondriac region. Its functions include lymphocyte production, blood cell storage, and blood cell destruction. (NCI) SPLEEN, HILUMSplenic HilumThe area of the spleen through which the vessels and nerves enter or exit the organ. (NCI) STERNAL MANUBRIUMSternal Manubrium The upper segment of the sternum, quadrangular in shape, as well as wider superiorly and narrower inferiorly. The sternal manubrium articulates with the clavicle and first two ribs. (NCI) The synovial juncture between the medial end of the clavicle and the anterior segment of the sternum. (NCI)

Spinal Cord

C12432

Spleen

C33601 C52730

Splenic Hilum Sternal Manubrium

C33615

STERNOCLAVICULAR JOINT

Sternoclavicular Joint

Sternoclavicular Joint

C12793STERNUMSterna; SternumThe long, flat bone connecting with the cartilages of the first seven ribs and the clavicle. (NCI) C12391 STOMACHStomachAn organ located under the diaphragm, between the liver and the spleen as well as between the esophagus and the small intestine. The stomach is the primary organ of food digestion. (NCI)

Sternum

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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C12436

CDISC Submission Value STRIATED MUSCLE TISSUE

CDISC Definition Striated muscles are appendicular and axial muscles typically connected at either or both ends to the bony skeleton of the body. Striated muscle fibers contain a highly organized, contractile cytoskeletal apparatus with a striated microscopic appearance; muscle contraction is typically under voluntary control. (NCI) The vein that drains the axillary vein and joins the internal jugular vein to form the brachiocephalic vein. It runs parallel to the subclavian artery.

NCI Preferred Term Striated Muscle Tissue

C12794

SUBCLAVIAN VEIN

Subclavian Vein

C12280 C102349 C12453

SUBGLOTTIS SUBLINGUAL REGION SUBSTANTIA NIGRA

Subglottis

The area of the larynx below the vocal cords down to the trachea. (NCI) A body region relating to the area under or adjacent to the tongue.

Subglottis Sublingual Region Substantia Nigra

Substantia Nigra

A large cell mass extending forward, over the dorsal surface of the crus cerebri, from the rostral border of the pons into the subthalamic region. It is composed of a dorsal stratum of closely spaced pigmented cells, the pars compacta, and a larger ventral region of widely scattered cells, the pars reticulata. The pars compacta includes numerous cells that project forward to the striatum (caudate nucleus and putamen) and contain dopamine, which acts as the primary neurotransmitter at the synaptic endings. Other, apparently non-dopaminergic cells project to portions of the ventral nucleus of thalamus, the superior colliculus and reticular formation. The nigrostriatal projection is reciprocated by a striatonigral fiber system with multiple neurotransmitters, chief among which is gamma-aminobutyric acid (GABA). The substantia nigra is involved in the metabolic disturbances associated with Parkinson's disease and Huntington's disease. (NCI) The large vein that terminates in the right atrium and transports deoxygenated blood from the head, neck, arms, and chest to the heart.

C12816

SUPERIOR VENA CAVA

Superior Vena Cava

C12903 C12467

SUPRACLAVICULAR LYMPH NODE SYMPATHETIC GANGLIA

Supraclavicular Lymph Node

A lymph node which is located above the clavicle. (NCI) A mass containing the cell bodies of sympathetic nerves. Sympathetic ganglia exist as paravertebral ganglia (located bilaterally adjacent to the spinal cord) or prevertebral ganglia (located close to the target organ).

Supraclavicular Lymph Node Sympathetic Ganglion

C33718 C33720 C33721 C33722

SYNOVIAL FLUID T1 VERTEBRA T10 VERTEBRA T11 VERTEBRA

Synovial Fluid; Synovia T1 Vertebra T10 Vertebra T11 Vertebra

A viscid fluid secreted by the synovial membrane, serving as a lubricant. (NCI) The first thoracic vertebra counting from the top down. (NCI) The tenth thoracic vertebra counting from the top down. (NCI) The eleventh thoracic vertebra counting from the top down. (NCI)

Synovial Fluid T1 Vertebra T10 Vertebra T11 Vertebra

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 245 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term T12 Vertebra T2 Vertebra T3 Vertebra T4 Vertebra T5 Vertebra T6 Vertebra T7 Vertebra T8 Vertebra T9 Vertebra Talus Tarsal Bone

NCI CodeCDISC Submission Value C33723 C33724 C33725 C33726 C33727 C33728 C33729 C33730 C33731 C52799 C12796

T12 VERTEBRAT12 VertebraThe twelfth thoracic vertebra counting from the top down. (NCI) T2 VERTEBRAT2 VertebraThe second thoracic vertebra counting from the top down. (NCI) T3 VERTEBRAT3 VertebraThe third thoracic vertebra counting from the top down. (NCI) T4 VERTEBRAT4 VertebraThe fourth thoracic vertebra counting from the top down. (NCI) T5 VERTEBRAT5 VertebraThe fifth thoracic vertebra counting from the top down. (NCI) T6 VERTEBRAT6 VertebraThe sixth thoracic vertebra counting from the top down. (NCI) T7 VERTEBRAT7 VertebraThe seventh thoracic vertebra counting from the top down. (NCI) T8 VERTEBRAT8 VertebraThe eighth thoracic vertebra counting from the top down. (NCI) T9 VERTEBRAT9 VertebraThe ninth thoracic vertebra counting from the top down. (NCI) TALUSTalusThe bone of the foot that connects with the tibia and fibula to form the ankle joint. (NCI) TARSUS BONEBone, Tarsal; Tarsus Bone; Tarsus Any one of the seven bones forming the instep of the foot. (NCI)

C12797TEMPORAL BONETemporal BoneA large irregular bone situated at the base and side of the skull, connected with the mandible via the temporomandibular joint. The temporal bone consists of the squamous, tympanic and petrous parts. The petrous portion of the temporal bone contains the vestibulocochlear organ of the inner ear. (NCI) C12353 C32888 C12412 TEMPORAL LOBELower lateral part of the cerebral hemisphere. (MSH2001) TEMPOROMANDIBULAR JOINT Jaw Joint; TMJThe joint between the head of the lower mandible and the temporal bone. (NCI)

Temporal Bone

Temporal Lobe Jaw Joint Testis

TESTISTesticle; TestisEither of the paired male reproductive glands that produce the male germ cells and the male hormones. (NCI)

C12459THALAMUSThalamusAn ovoid mass composed predominantly of gray substance and associated laminae of white substance. The thalamus is divided into anterior, medial, and lateral parts. The function of the thalamus is to relay sensory impulses and cerebellar and basal ganglia projections to the cerebral cortex. The thalamus is positioned within the posterior part of the diencephalon forming most of each lateral wall of the third ventricle. (NCI) C33763THIGHThighA part of the lower limb, located between hip and knee. (NCI)

Thalamus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC SynonymCDISC DefinitionNCI Preferred Term 3RD DIAG; THIRD DIAGONAL BRANCH ARTERY SEGMENT The third artery arising from the left anterior descending (LAD) artery that supplies the anterolateral wall, when counted from proximal to distal. Third Diagonal Branch Artery

NCI CodeCDISC Submission Value C102350 THIRD DIAGONAL BRANCH ARTERY

C102351THIRD OBTUSE MARGINAL BRANCH ARTERY

3RD OM; The third artery arising from the left circumflex artery THIRD OBTUSE that supplies the lateral wall, when counted from MARGINAL proximal to distal. BRANCH ARTERY SEGMENT 3RD LPL; THIRD POSTEROLATE RAL DESCENDING ARTERY SEGMENT 3RD RPL; THIRD RIGHT POSTEROLATE RAL ARTERY SEGMENT In an individual with a left-dominant heart, this is the third branch that arises from the circumflex artery atrioventricular groove continuation when counted from proximal to distal. It supplies the posterolateral wall.

Third Obtuse Marginal Branch Artery

C102352THIRD POSTEROLATERAL DESCENDING ARTERY

Third Posterolateral Descending Artery

C102353THIRD RIGHT POSTEROLATERAL ARTERY

In an individual with a right-dominant heart, this is the third branch that arises from the right coronary artery distal to the right posterior descending artery, when counted from proximal to distal.

Third Right Posterolateral Artery

C12905

THORACIC CAVITYThoracic CavityThe cavity in the vertebrate body enclosed by the ribs between the diaphragm and the neck and containing the lungs and heart. (NCI) Vertebra One of 12 vertebrae in the human vertebral column. The thoracic vertebrae are situated between the seventh cervical vertebra down to the first lumbar vertebra. (NCI)

Thoracic Cavity

C12798THORACIC VERTEBRAThoracic

Thoracic Vertebra

C12799 C54272 C12433

THORAXThoraxThe division of the body lying between the neck and the abdomen. (NCI) THROATThroatThe narrow passage from the mouth to the cavity at the back of the mouth. (NCI) THYMUS GLANDThymus GlandA bi-lobed organ surrounded by a connective tissue capsule. It is located in the upper anterior portion of the chest, behind the sternum. It is composed predominantly of lymphocytes and fewer epithelial cells. Connective tissue septa separate the lobes into lobules. The lobules contain an outer portion (cortical zone) which is rich in lymphocytes and an inner portion (medullary zone) which is rich in epithelial cells. It is an organ essential for the development of the immune system. Its function is the maturation of the progenitor lymphoid cells to thymocytes and subsequently to mature T-cells. It reaches its greatest weight at puberty and subsequently begins to involute. (NCI) THYROID GLANDThyroid GlandAn endocrine gland located at the base of the neck that produces and secretes thyroxine and other hormones. Thyroxine is important for metabolic control. (NCI)

Thorax Throat Thymus Gland

C12400

Thyroid Gland

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresource


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CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym

NCI Code C32887

CDISC Submission Value THYROID GLAND ISTHMUS

CDISC Definition The narrow, central portion of the thyroid gland that crosses the trachea anteriorly and connects the two lobes of the gland. (NCI)

NCI Preferred Term Thyroid Gland Isthmus

C32973 C33491 C12800 C33788 C33790 C12422

THYROID GLAND, LEFT LOBE THYROID GLAND, RIGHT LOBE TIBIA TOE TOENAIL TONGUE

Left Thyroid Gland Lobe Right Thyroid Gland Lobe Tibia Toe Toenail Tongue

The cone-like lobe of the thyroid gland that is located in the left side of the trachea. (NCI) The cone-like lobe of the thyroid gland that is located in the right side of the trachea. (NCI) A bone located between the femur and the tarsus, being part of the lower leg. (NCI) One of the terminal digits of the foot. (NCI) A thin, horny translucent plate covering the end of each toe. (NCI) The muscular organ located in the floor of the mouth and serving as the principal organ of taste and modification of the voice in speech. (NCI) The two organs situated in the throat on either side of the narrow passage from the mouth to the pharynx. They are composed of lymphoid tissues. (NCI) The anatomic space in the root of a tooth that contains nerves, blood vessels, and connective tissue. (NCI) The fibrocartilaginous, mucous-lined tube passing from the larynx to the bronchi. (NCI) A combination of syndesmosis and synovial joints formed by the articulation of the talus with the navicular and the calcaneus with the cuboid.

Left Thyroid Gland Lobe Right Thyroid Gland Lobe Tibia Toe Toenail Tongue

C12802

TONSIL

Tonsil

Tonsil

C66864 C12428 C102354

TOOTH CANAL TRACHEA TRANSVERSE TARSAL JOINT TRAPEZIAL BONE TRAPEZIUS MUSCLE

Tooth Canal Trachea; Windpipe

Tooth Canal Trachea Transverse Tarsal Joint

C12857 C33809

Trapezial Bone Trapezius Muscle

A carpal bone on the thumb side of the hand that articulates with the 1st and 2nd metacarpals. (NCI) One of a pair of flat, large, triangular muscles that extend from the external occipital protuberance and the medial third of the superior nuchal line of the occipital bone to the middle of the back. The trapezius muscle is involved in moving the shoulder and arm. (NCI) A carpal bone located between the trapezium and capitate bones. (NCI) A carpal bone located between the lunate and pisiform bones. (NCI) The fifth set of paired nerves of the face that emerge from the brain steam. These nerves have sensory and motor functions in the face, oral cavity, and nasal cavity. (NCI) A bony protrusion on the femoral bone to which muscles are attached. (NCI) The cranial nerve that controls the superior oblique muscle of the eye. (NCI)

Trapezial Bone Trapezius Muscle

C12859 C12858 C12806

TRAPEZOID BONE TRIANGULAR BONE TRIGEMINAL NERVE

Trapezoid Bone Triangular Bone Fifth Cranial Nerve; Nervus Trigeminus; Trigeminal Nerve Trochanter Trochlear Nerve Trunk

Trapezoid Bone Triangular Bone Trigeminal Nerve

C33814 C12808 C33816

TROCHANTER TROCHLEAR NERVE TRUNK

Trochanter Trochlear Nerve

The body excluding the head and neck and limbs. (NCI) Trunk

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 248 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Tunica Intima

NCI Code C33820

CDISC Submission Value TUNICA INTIMA

CDISC Definition The inner most layer of the blood vessel wall. The consistency of the intima will vary depending on the type of blood vessel, but will always have an endothelial layer with a basal lamina. It may contain collagen and elastic fibers. (NCI) A thin membrane that separates the external auditory canal from the middle ear. The movement of the tympanic membrane in response to air pressure changes in the external ear facilitates the transmission of sound energy by causing vibration of the ossicular chain. (NCI) One of the bones that comprise the forearm. The largest aspect articulates with the humerus at the elbow joint and the smallest portion of the ulna articulates with the carpal bones in the wrist. (NCI) A portion of the pancreas that extends behind the superior mesenteric artery and superior mesenteric vein. (NCI) The thick-walled tube that carries urine from each kidney to the bladder. (NCI) The tube carrying urine from the bladder to outside of the body. (NCI) The portion of the urethra that extends from the meatus to the membranous urethra. (NCI) The portion of the urethra that spans the corpus spongiosum. (NCI) The portion of the urethra that is located on the posterior aspect of the urogenital diaphragm. (NCI) That part of the male urethra that passes through the prostate gland. (NCI) The organs involved in the creation and excretion of urine. (NCI) A hollow, thick-walled, muscular organ located within the pelvic cavity of a woman. Within the uterus the fertilized egg implants and the fetus develops during pregnancy. (NCI) The pigmented layer of the eyeball between the tough, white outer coat of the eye and the retina. (NCI) The female genital canal, extending from the uterus to the vulva. (NCI) The 10th cranial nerve. The vagus is a mixed nerve which contains somatic afferents (from skin in back of the ear and the external auditory meatus), visceral afferents (from the pharynx, larynx, thorax, and abdomen), parasympathetic efferents (to the thorax and abdomen), and efferents to striated muscle (of the larynx and pharynx). (MSH2001) Duct carrying spermatozoa. (NCI)

NCI Preferred Term Tunica Intima

C12502

TYMPANIC MEMBRANE

Tympanic Membrane

Tympanic Membrane

C12809

ULNA

Ulna Bone

Ulna

C62432

UNCINATE PROCESS OF PANCREAS URETER URETHRA URETHRA, ANTERIOR URETHRA, PENILE URETHRA, POSTERIOR

Uncinate Process of Pancreas Ureter Urethra Anterior Portion of the Urethra Penile Portion of the Urethra Posterior Portion of the Urethra Prostatic Urethra Urinary System Uterus; Womb

Uncinate Process of Pancreas

C12416 C12417 C61125 C61123 C61126

Ureter Urethra Anterior Portion of the Urethra Penile Portion of the Urethra Posterior Portion of the Urethra

C13101 C12413 C12405

URETHRA, PROSTATIC URINARY SYSTEM UTERUS

Prostatic Urethra Urinary System Uterus

C12811 C12407 C12812

UVEA VAGINA VAGUS NERVE

Uvea Vagina

Uvea Vagina Vagus Nerve

C12813

VAS DEFERENS

Vas Deferens

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 249 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74456 - LOC - Anatomical Location Codelist extensible: Yes
CDISC Synonym Vein Vena Cava Vertebral Column

NCI Code C12814 C12817 C12998

CDISC Submission Value VEIN VENA CAVA VERTEBRAL COLUMN

CDISC Definition A blood vessel that carries blood towards the heart. A large vein which returns blood from the head, neck and extremities to the heart. (NCI) A series of bones, muscles, tendons, and other tissues reaching from the base of the skull to the tailbone. The vertebral column forms the axis of the skeleton and encloses as well as protects the spinal cord and the fluid surrounding the spinal cord. (NCI) The eighth cranial nerve. Vein

NCI Preferred Term

Vena Cava Vertebral Column

C12996 C12822

VESTIBULOCOCHLEAR NERVE VOCAL CORD Vocal Cord

Vestibulocochlear Nerve Vocal Cord

A pair of small bands of muscle that stretch from the thyroid cartilage in front to the arytenoid cartilage in back of the larynx. The vocal cords help prevent food entering the lungs and produce sound through vibration. (NCI) A thin, paired or unpaired, trapezoidal bone of the skull located in the floor of the nasal cavity. The vomer forms the posterior and inferior parts of the nasal septum. (NCI)

C33888

VOMER

Vomer

Vomer

C12408

VULVA

External Genitalia; Vulva

The external, visible part of the female genitalia Vulva surrounding the urethral and vaginal opening. The vulva includes the clitoris and inner as well as outer labia. (NCI) The abdominal circumference at the navel. (NCI) A joint between the distal end of the radius and the proximal row of carpal bones. (NCI) The cartilage just below the sternal body. (NCI) Waist Wrist Joint Xiphoid Process

C64192 C33894 C33895

WAIST WRIST JOINT XIPHOID PROCESS

Waist Wrist Joint Xiphoid Process

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 250 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101857 - LSNCMPX - Lesion Complexity Codelist extensible: No
CDISC Synonym Low Risk

NCI Code C100037

CDISC Submission Value ACC/AHA LESION COMPLEXITY SCORE A

CDISC Definition Discrete (less than 10 mm length) and concentric and readily accessible and non-angulated segment less than 45 degrees and smooth contour and little or no calcification and less than totally occlusive and not ostial in location and no major branch involvement and absence of thrombus. Tubular (10-20 mm length) or eccentric or moderate tortuosity of proximal segment or moderately angulated segment, 45-90 degrees or irregular contour or moderate to heavy calcification or ostial in location or bifurcation lesions requiring double guidewires or some thrombus present or total occlusion less than3 months old. Diffuse (length greater than 2cm) or excessive tortuosity of proximal segment or extremely angulated segments greater than 90 degrees or total occlusions greater than 3 months old and/or bridging collaterals or inability to protect major side branches or degenerated vein grafts with friable lesions.

NCI Preferred Term American College of Cardiology American Heart Association Lesion Complexity Score A

C100038

ACC/AHA LESION COMPLEXITY SCORE B

Medium Risk

American College of Cardiology American Heart Association Lesion Complexity Score B

C100039

ACC/AHA LESION COMPLEXITY SCORE C

High Risk

American College of Cardiology American Heart Association Lesion Complexity Score C

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 251 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101858 - LVEFMRE - Left Ventricular Ejection Fraction Measurement Result Codelist extensible: Yes
CDISC Synonym

NCI Code C99512

CDISC Submission Value HYPERDYNAMIC

CDISC Definition A pathologically high percentage of blood that is forced from the heart ventricle to produce cardiac output. This is often the result of ventricular dilation due to hypertrophic cardiomyopathy. Quantitatively, the ejection fraction is considered higher than 70%. Slightly less than normal amount of blood that is forced from the heart ventricle to produce cardiac output. Quantitatively, the ejection fraction is considered between 40% to 49%. Moderately less than normal amount of blood that is forced from the heart ventricle to produce cardiac output. Quantitatively, the ejection fraction is considered between 30% to 39%. The usual amount of blood that is forced from the heart ventricle to produce cardiac output. Quantitatively, the ejection fraction is considered between 50% to 70%. Severely less than normal amount of blood that is forced from the heart ventricle to produce cardiac output. Quantitatively, the ejection fraction is considered less than 30%.

NCI Preferred Term Hyperdynamic Ventricular Ejection Fraction

C99507

MILD DYSFUNCTION

Mildly Abnormal Ejection Fraction

C99508

MODERATE DYSFUNCTION

Moderately Abnormal Ejection Fraction

C99513

NORMAL EJECTION FRACTION

Normal Ventricular Ejection Fraction

C99509

SEVERE DYSFUNCTION

Severely Abnormal Ventricular Ejection Fraction

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 252 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C76348 - MARISTAT - Marital Status Codelist extensible: Yes
CDISC Synonym

NCI Code C76240 C51776 C53262 C76241 C51777 C51773 C51774 C76242 C51775

CDISC Submission Value ANNULLED DIVORCED DOMESTIC PARTNER INTERLOCUTORY LEGALLY SEPARATED MARRIED NEVER MARRIED POLYGAMOUS WIDOWED

CDISC Definition Marriage contract has been declared null and to not have existed. (HL7) Marriage contract has been declared dissolved and inactive. (HL7)

NCI Preferred Term Annulled Divorced Domestic Partnership Interlocutory Marital Status Separated Married Never Married Polygamous Widowed

Domestic Partner

Person declares that a domestic partnership relationship exists. (HL7) Temporary order issued during the course of litigation. (HL7) A person living apart from his/her spouse by legal arrangement. (HL7) A current marriage contract is active. (HL7) No marriage contract has ever been entered. (HL7) More than 1 current spouse. (HL7) The spouse has died. (HL7)

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CDISC SDTM Controlled Terminology, 2012-06-29


C101859 - MCRCSPTM - Mechanical Circulatory Support Placement Timing Codelist extensible: No
CDISC Synonym In Place at Start of Procedure Inserted during a Non PCI Procedure

NCI Code C99981 C99962

CDISC Submission Value IN PLACE AT START OF PROCEDURE INSERTED DURING A NON-PERCUTANEOUS CORONARY INTERVENTION PROCEDURE INSERTED DURING PROCEDURE AND AFTER PERCUTANEOUS CORONARY INTERVENTION STARTED INSERTED DURING PROCEDURE BUT PRIOR TO PERCUTANEOUS CORONARY INTERVENTION

CDISC Definition Mechanical Circulatory Support was in place at the start of the procedure. Mechanical Circulatory Support was inserted during a non-Percutaneous Coronary Intervention (PCI) procedure.

NCI Preferred Term Mechanical Circulatory Support in Place at Start of Procedure Inserted During a Non-Percutaneous Coronary Intervention

C99964

Inserted during Procedure and after PCI Started

Mechanical Circulatory Support was inserted during the procedure after Percutaneous Coronary Intervention (PCI) started.

Inserted During Procedure and After Percutaneous Coronary Intervention Began

C99963

Inserted during Procedure but Prior to PCI

Mechanical Circulatory Support was inserted during the procedure prior to percutaneous coronary intervention (PCI).

Inserted During a Procedure but Prior to Percutaneous Coronary Intervention

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C96777 - MEDEVAL - Medical Evaluator Codelist extensible: Yes
CDISC Synonym

NCI Code C96561 C17721 C96692 C96606 C17821 C96611 C96612 C17824 C94530 C94531 C28747 C94532 C94533

CDISC Submission Value ADJUDICATOR NEUROLOGIST NEUROLOGIST 1 NEUROLOGIST 2 ONCOLOGIST ONCOLOGIST 1 ONCOLOGIST 2 RADIOLOGIST RADIOLOGIST 1 RADIOLOGIST 2 READER READER 1 READER 2

CDISC Definition An individual that presides over and arbitrates between individuals or organizations. A physician who specializes in diagnosing and treating diseases and disorders of the nervous system. A neurologist performing the assessment that is given the designation of one. A neurologist performing the assessment that is given the designation of two. A physician who specializes in diagnosing and treating cancer. (NCI) An oncologist performing the assessment that is given the designation of one. An oncologist performing the assessment that is given the designation of two. A physician who specializes in the diagnostic and/or therapeutic uses of radiation. (NCI) A radiologist performing the assessment that is given the designation of one. A radiologist performing the assessment that is given the designation of two. An individual who takes non-quantifiable data and provides quantifiable assessments for that data. A reader performing the assessment that is given the designation of one. A reader performing the assessment that is given the designation of two.

NCI Preferred Term Adjudicator Neurologist Neurologist 1 Neurologist 2 Oncologist Oncologist 1 Oncologist 2 Radiologist Radiologist 1 Radiologist 2 Reader Reader 1 Reader 2

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C23015

CDISC Submission Value ACID FAST STAIN

CDISC Definition A microscopy staining method used to examine a specimen for the presence of acid-fast microorganisms, specifically mycobacteria. A microscopy staining method that utilizes acridine orange, a fluorescent cationic dye that is selective for nucleic acids, to determine the presence of viable cells or microorganisms in a sample. Acridine orange interacts with RNA and DNA and the lysosomal compartment of cells. A method to determine microbial susceptibility to antibiotics in which test bacteria is inoculated onto agar plates with serial dilutions of know quantities of antibiotics. The minimum inhibitory concentration of antibiotic is assessed. A microscopy staining method that utilizes periodic acid, an oxoacid of iodine, Schiff reagent, the reaction product of fuchsine and sodium bisulfite, and Alcian blue, a water soluble copper phthalocyanine dye. This staining method is used to differentially stain glycoproteins. A microscopy staining method that utilizes alcian blue, a cationic, water soluble copper-containing phthalocyanine dye to determine the presence of acid mucopolysaccharides and glycosaminoglycans. An X-ray representation of blood vessels made after the injection of a radiopaque substance. A method used to detect organisms that have resistance to a single concentration of antibiotics in an agar matrix. A method to determine the microbial susceptibility to two or more antibiotics. Numerical result translated into indifference, antagonism, synergism, or additive. A spectrometric method that determines the type and concentration of metal elements in a sample, based upon the principle that each elemental metal absorbs a particular wavelength of ultraviolet light when exposed to heat. Testing conducted utilizing a manual or microprocessor audiometer to test for hearing loss. Listening with a device, such as a stethoscope, to anatomical locations that produce audible sounds like the heart, lungs and abdomen. A test that detects beta lactamase produced by Staphylococcus species, Haemophilus species, Moraxella catarrhalis, and Neisseria gonorrhoeae. A microscopy staining method that utilizes calcofluor, a fluorescent dye that preferentially stains chitin and cellulose on the cell walls of fungi, parasites, and some cysts of the Pneumocystis genus.

NCI Preferred Term Acid Fast Bacillae Staining Method

C85554

ACRIDINE ORANGE STAIN

Acridine Orange Staining Method

C85555

AGAR DILUTION

Agar Dilution Method

C92304

ALCIAN BLUE AND PERIODIC ACID SCHIFF STAIN

Alcian Blue and Periodic Acid Schiff Staining Method

C92299

ALCIAN BLUE STAIN

Alcian Blue Staining Method

C16805 C85557

ANGIOGRAM ANTIBIOTIC AGAR SCREEN

Lymphangiogram Antibiotic Agar Screening Method

C85558

ANTIMICROBIAL COMBINATION TESTING ATOMIC ABSORPTION SPECTROMETRY

Antimicrobial Combination Testing Method Atomic Absorption Spectroscopy

C85574

C38036 C85573

AUDIOMETRY AUSCULTATION

Audiometric Test Auscultation

C85576

BETA LACTAMASE

Beta Lactamase Screening Method

C85577

CALCOFLUOR WHITE STAIN

Calcofluor White Staining Method

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C85578

CDISC Submission Value CELLULOSE TAPE

CDISC Definition A microbiological technique for specimen collection and mounting for microscopic examination that utilizes a cellulose-based adhesive ribbon. A technique for the separation of complex mixtures that relies on the differential affinities of substances for a gas or liquid mobile medium and for a stationary adsorbing medium through which they pass.

NCI Preferred Term Cellulose Tape Method

C16431

CHROMATOGRAPHY

Chromatography

C40960

CISH

Chromogenic in Situ Hybridization

A laboratory procedure that combines the Chromogenic in situ Hybridization sequence-specific detection aspects of FISH with the simple detection methods of immunohistochemistry. Briefly, sequence-specific probes are hybridized to cells fixed on slides and the sequestered probe is visualized by a peroxidase reaction. It has the advantage of being a less costly assay that does not require fluorescence microscopy with results that are stable over time. A series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. A microscopic technique in which the light that does not come into contact with the structure or details of interest is subtracted from the ocular image. This yields an image in which the structure or details are alight while the areas where the structures or details are absent are dark. A method to determine microbial susceptibility to antibiotics in which filter paper disks containing known concentrations of antibiotics are placed on the agar surface that has been previously inoculated with the bacteria of interest. Microbial susceptibility is assessed by measuring the area around the disk that is free of microbial growth. A technique for scanning bone and measuring bone mineral density (BMD). Computed Tomography

C17204

CT SCAN

Computed Tomography; CT

C85837

DARK FIELD MICROSCOPY

Dark Field Microscopy

C85595

DISK DIFFUSION

Disk Diffusion Method

C48789 C17455

DXA SCAN EIA Enzyme Immunoassay

Dual X-ray Absorptiometry Enzyme Immunoassay

Any of several immunoassay methods that use an enzyme covalently linked to an antigen or antibody as a label; the most common types are enzyme-linked immunosorbent assay (ELISA) and enzyme-multiplied immunoassay technique (EMIT). The motion of charged particles in a colloid under the influence of an electric field; particles with a positive charge go to the cathode and negative to the anode.

C16536

ELECTROPHORESIS

Electrophoresis

C16553

ELISA

Enzyme-linked Immunosorbent Assay

An immunoassay for detecting and measuring antigens or antibodies in a solution; the solution is run over a surface to which immobilized antibodies specific to the substance have been attached, and if the substance is present, it will bind to the antibody layer, and its presence is verified and visualized with an application of antibodies that have been tagged in some way. An examination of the body using an endoscope.

ELISA

C16546

ENDOSCOPY

Endoscopic Procedure

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 257 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C85596

CDISC Submission Value EPSILOMETER

CDISC Definition A method to determine microbial susceptibility to antibiotics in which a plastic strip impregnated with the antibiotic of interest is placed on an agar plate that has been inoculated with bacteria. The antibiotic diffuses from the strip producing a concentration gradient of drug on the agar. The point at which the elliptical shaped area of growth inhibition meets the strip is the minimum inhibitory concentration of the drug of interest.

NCI Preferred Term Epsilometry

C17563

FISH

Fluorescence in Situ Hybridization

A physical mapping approach that uses fluorescent tags to detect hybridization of probes within metaphase chromosomes or less condensed somatic interphase chromatin. This technique can be used for identification of chromosomal abnormalities and for gene mapping. A bioassay in which fluorescent-coupled antibodies or antigens are used to quantify or qualify a biological response to a stimulus. Microscopy of specimens stained with fluorescent dye (usually fluorescein isothiocyanate) or of naturally fluorescent materials, which emit light when exposed to ultraviolet or blue light. A microscopy staining method that utilizes Giemsa, a mixture of ethylene blue and eosin, which forms purplish-black crystals when dried. This stain preferentially binds to the phosphate groups of DNA and aggregates at areas with an increase in adenine-thymine binding, thus leading to chromosomal staining patterns that lend themselves to g-banding analysis. Additionally Giemsa can be used as a differential stain to determine microbial cell adherence to human cells as well as in the diagnosis of malaria, spirochete, and protozoal infections. A method to determine microbial susceptibility to antibiotics in which an agar plate, which has a concentration gradient of the drug within the agar, is streaked with the microorganism of interest. Microbial susceptibility as well as minimum inhibitory concentration of antibiotic is assessed. A microscopy staining method for staining and identifying bacteria, based on the differential retention of a crystal violet-iodine complex within the cell membrane. Gram-positive organisms will appear blue-black or purple while Gram-negative organisms will appear red.

Fluorescence in situ Hybridization

C17370

FLUORESCENT IMMUNOASSAY FLUORESCENT MICROSCOPY

Fluorescent Antibody Procedure

C16856

Fluorescence Microscopy

C85598

GIEMSA STAIN

Giemsa Staining Method

C85599

GRADIENT DIFFUSION

Gradient Diffusion Method

C23014

GRAM STAIN

Gram Staining Method

C23011

HEMATOXYLIN AND EOSIN STAIN

H&E Stain

A microscopy staining method that utilizes two separate dyes, one staining the nucleus and the other staining the cytoplasm and connective tissue. Hematoxylin is a dark purplish dye that stains the chromatin (nuclear material) within the nucleus. Eosin is an orangish-pink to red dye that stains the cytoplasmic material including connective tissue and collagen.

Hematoxylin and Eosin Staining Method

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C85556

CDISC Submission Value HIGH LEVEL AMINOGLYCOSIDE SCREEN HPLC

CDISC Definition A method to determine microbial susceptibility to high concentrations of aminoglycoside antibiotics.

NCI Preferred Term Aminoglycoside Screening Method

C16434

High Performance Liquid Chromatography

Frequently referred to simply as HPLC, this form of column chromatography is used frequently in biochemistry. The analyte is forced through a column by liquid at high pressure, which decreases the time the separated components remain on the stationary phase. Less time on the column then translates to narrower peaks in the resulting chromatogram and thence to better selectivity and sensitivity. An analytical technique wherein high performance liquid chromatography is coupled to mass spectrometry in order to separate, identify, and quantify substances in a sample.

High Performance Liquid Chromatography

C18475

HPLC/MS

High Performance Liquid Chromatography/ Mass Spectrometry Immunohistoche mistry

Liquid Chromatography Mass Spectrometry

C23020

IHC

Immunohistochemical staining techniques allow for the visualization of antigens via the sequential application of a specific antibody to the antigen (primary antibody), a secondary antibody to the primary antibody and an enzyme complex with a chromogenic substrate. The enzymatic activation of the chromogen results in a visible reaction product at the antigen site. The specimen may then be counterstained and coverslipped. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen. A microscopy staining method that utilizes India Ink, a water soluble carbon-based black ink, to determine the presence of microorganisms that are surrounded by a gelatinous capsule. This is a negative staining method in which background is stained in black and the microbes and microscopic structures of interest remain white. A spectrometric method that determines the type and concentration of elements or chemicals in a sample, based upon the principle that the atoms in a sample will vibrate or rotate at a specific frequency when exposed to infrared light. A microscopy staining method that utilizes Iodine, an element belonging to the halogen group, which specifically stains polysaccharides such as cellulose, chitin, glycogen, and starch a blue color. A microscopy staining method that utilizes a mixture of iron and hematoxylin to visualize intracellular structures in a microscopic sample. In this dye system, iron acts as a mordant to hematoxylin rendering it insoluble, thereby allowing irreversible blue-black colored dyeing to the cell nucleus.

Immunohistochemistry Staining Method

C85642

INDIA INK STAIN

India Ink Staining Method

C85643

INFRARED SPECTROMETRY

Infrared Spectrometry

C85649

IODINE STAIN

Iodine Staining Method

C85650

IRON HEMATOXYLIN STAIN

Iron Hematoxylin Staining Method

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C85651

CDISC Submission Value KINYOUN STAIN

CDISC Definition A microscopy acid fast staining method that utilizes kinyoun carbol fuchsin, a dye containing basic fuchsin in solution with ethyl alcohol and aqueous phenol. This acid fast staining technique does not require heating during the primary staining step involving the carbol fuchsin. A microscopy staining method that utilizes lead citrate, a mixture of lead nitrate and sodium citrate, and has applications for electron microscopy staining. Light microscopy is a technique for producing visible images of structures or details which are too small to be otherwise seen by the human eye. It involves passing light transmitted through or reflected from the subject through a series of lenses to be detected directly by the eye, imaged on a photographic plate, or captured digitally. A microscopy staining method that utilizes luxol fast blue, an alcohol soluble copper phthalocyanine dye, and cresyl violet, an organic compound that is commonly used as a counter stain, to determine the presence of myelin as well as helicobacter and campylobacter bacterial species. A method to determine the minimum inhibitory concentration (MIC) of antibiotics in which growth media is pipetted into a test tube. Each tube contains a known concentration of drug and is inoculated with a known quantity of bacteria. The tubes are incubated for a specified period of time and each is assessed for bacterial cell growth. The drug concentration in the first tube showing no growth is known as the MIC for that antibiotic. A type of radiography used specifically to examine breast tissue. The procedure utilizes a low-dose of x-rays or radiation to generate an image. An analytical technique wherein ions are separate according to their ratio of charge to mass. From the mass spectrum produced, the atomic weight of the particle can be deduced. A method to determine the minimum inhibitory concentration (MIC) of antibiotics in which growth media is pipetted into a multi-well plate. Each well contains a known concentration of drug which is inoculated with a known quantity of bacteria. The plate is incubated for a specified period of time and each well is assessed for bacterial cell growth. The drug concentration in the first well showing no growth is known as the MIC for that antibiotic. Any technique in which a sample is condensed in order to afford greater sensitivity for the detection of microorganisms. A microscopy staining method, that does not utilize heat in the slide preparation, used to examine a specimen for the presence of acid-fast microorganisms, specifically nocardia.

NCI Preferred Term Kinyoun Staining Method

C92301

LEAD CITRATE STAIN

Lead Citrate Staining Method

C17995

LIGHT MICROSCOPY

Light Microscopy

C92300

LUXOL FAST BLUE AND CRESYL VIOLET STAIN

Luxol Fast Blue and Cresyl Violet Staining Method

C85697

MACRO BROTH DILUTION

Macro Broth Dilution Method

C16818

MAMMOGRAPHY

Mammography

C17156

MASS SPECTROMETRY

Mass Spectrometry

C85701

MICRO BROTH DILUTION

Micro Broth Dilution Method

C85702

MICROBIAL CONCENTRATION MODIFIED ACID FAST STAIN

Microbial Concentration Method

C85736

Modified Acid Fast Staining Method

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym Magnetic Resonance Imaging

NCI Code C16809

CDISC Submission Value MRI

CDISC Definition Imaging that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide amazingly clear and detailed pictures of internal organs and tissues. The technique is valuable for the diagnosis of many pathologic conditions, including cancer, heart and vascular disease, stroke, and joint and musculoskeletal disorders. Watching something and taking note of what happens. A quantification of the amount of light that is absorbed by or transmitted through a substance. A method of feeling with the hands during a physical examination. The health care provider touches and feels the patient's body to examine the size, consistency, texture, location and tenderness of an organ or body part. An endoscopic examination of the pharynx, larynx, trachea and esophagus. A diagnostic test performed on a tooth by tapping on the crown with a dental instrument. A microscopy staining method that utilizes Schiff's reagent, a solution composed of pararosanilin treated with sulfurous acid, which selectively reacts with and stains aldehydes pink to determine the presence of glycogen, mucin, mucoprotein, glycoprotein, as well as fungi. Periodic Acid Schiff staining is useful for outlining tissue structures such as basement membranes, capsules and blood vessels. An imaging technique that utilizes positron emission tomography and computed tomography in a single machine. A microscopic technique in which the amplitude shift that occurs when light passes through a specimen highlights structures or details within the specimen. The process by which an image is acquired by recording light emissions.

NCI Preferred Term Magnetic Resonance Imaging

C25598 C85776 C16950

OBSERVATION OPTICAL DENSITY MEASUREMENT PALPATION

Observation Optical Density Measurement Palpation

C94528 C62298 C23019

PANENDOSCOPY PERCUSSION PERIODIC ACID SCHIFF STAIN

Panendoscopy Dental Percussion Periodic Acid Schiff Staining Method

C17007

PET/CT SCAN

Positron Emission Tomography

C16857

PHASE CONTRAST MICROSCOPY PHOTOGRAPHY RIA Radioimmunoass ay

Phase-Contrast Microscopy

C94527 C17057

Photography Radioimmunoassay

Radioimmunoassay (RIA) is an immunological technique, which quantitatively determines antigen and antibody concentrations, using a radioactively labeled substance (radioligand), either directly or indirectly. A microscopy staining method that utilizes a modified trichrome stain to determine the presence of microspordial, sporulating species. This staining technique substitutes aniline blue for the fast green counterstain of the original trichrome staining method and decreased levels of phosphotungstic acid in the reagent. An electron microscopy imaging technique that is utilized to examine structural components of a sample by passing electrons through a specimen that has been coated with a heavy metal.

C85801

RYAN BLUE STAIN

Ryan Blue Staining Method

C16855

SCANNING ELECTRON MICROSCOPY

Scanning Electron Microscopy

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C62667

CDISC Submission Value SCINTIGRAPHY

CDISC Definition

NCI Preferred Term

An imaging technique that uses a small dose of a Radionuclide Imaging radioactive chemical (isotope) called a tracer that can detect sites of cancer growth, trauma, infection or degenerative disorders. The tracer, which is either injected into a vein or swallowed, travels through the bloodstream to the target organ, and emits gamma rays, which are detected by a gamma camera and analyzed by a computer to form an image of the target organ. (NCI) Examination of the anterior segment of the eye using a medical instrument called a slit lamp. Spiral Computed Tomography A method of examining body organs by scanning them with X rays and using a computer to construct a series of cross-sectional scans along a single axis. A blood smear technique used to make a thick blood smear on a microscope slide which is generally used to look for blood parasites such as those causing malaria. A blood smear technique used to make a thin blood smear on a microscope slide which is generally used to look for blood parasites such as those causing malaria. A microscopy staining method that utilizes toluidine blue, a solution composed of tolonium chloride, to determine the presence of mast cells, lignin, proteoglycans and glycosaminoglycans. A therapeutic procedure that involves the irradiation of the whole body with ionizing or non-ionizing radiation. (NCI) A diagnostic radiologic test that involves the examination of the entire body in a single procedure. An electron microscopy imaging technique that is utilized to examine structural components of a sample by passing electrons through the specimen. A microscopy staining method that utilizes two or more colored, acidic dyes of contrasting colors. Masson trichrome is a mixture of three dyes including aniline blue, Beibrich scarlet and Weigert's iron hematoxylin. Other related, modified trichrome staining methods include Lillie's trichrome, Gomori's trichrome and Mallory's trichrome. A technique in which high-frequency sound waves are bounced off internal organs and the echo pattern is converted into a 2 dimensional picture of the structures beneath the transducer. A microscopy staining method that utilizes uranyl acetate, a water insoluble yellow crystalline solid, which is used as a negative stain in electron microscopy. Slit-lamp Examination Spiral CT

C75583 C20645

SLIT LAMP SPIRAL CT

C85819

THICK SMEAR

Thick Smear Technique

C85820

THIN SMEAR

Thin Smear Technique

C92302

TOLUIDINE BLUE STAIN

Toluidine Blue Staining Method

C15350

TOTAL BODY IRRADIATION

Total-Body Irradiation

C96640 C18216

TOTAL BODY RADIOGRAPHY TRANSMISSION ELECTRON MICROSCOPY TRICHROME STAIN

Total Body Radiography Transmission Electron Microscopy

C23012

Trichrome Staining Method

C17230

ULTRASOUND

Ultrasound Imaging

C92303

URANYL ACETATE STAIN

Uranyl Acetate Staining Method

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C85492 - METHOD - Method Codelist extensible: Yes
CDISC Synonym

NCI Code C85828

CDISC Submission Value WEBER GREEN STAIN

CDISC Definition A microscopy staining method that utilizes a modified trichrome stain to determine the presence of microspordial, sporulating species. The staining method utilizes chromotrope 2R, a red acidic dye, the counterstain fast green, and phosphotungstic acid. A microscopy staining method that utilizes the Romanowsky stains, eosin and methylene blue, solubilized in methanol. In this staining protocol, methanol is also utilized as a fixative agent prior to staining. A microscopy staining method that is a combination of the Wright and Giemsa staining protocols and utilizes the Romanowsky stains, which are mixtures of eosin and thiazine dyes such as methylene blue. It produces darker blue and magenta shades than the giemsa stain alone, which may provide better contrast in microscopy. A spectrometric method that determines the type and concentration of elements or chemicals in a sample, based upon the principle that each element emits fluorescent light of a particular wavelength when exposed to an X-ray.

NCI Preferred Term Weber Green Staining Method

C85829

WRIGHT STAIN

Wright Staining Method

C23041

WRIGHT-GIEMSA STAIN

Wright-Giemsa Staining Method

C85830

X-RAY FLUORESCENCE SPECTROMETRY

X-Ray Fluorescence Spectrometry

C38101

XRAY

Radiography

A radiographic procedure using the emission of x-rays to form an image of the structure penetrated by the radiation. A microscopy acid fast staining method that utilizes Ziehl-Neelsen carbol fuchsin, acid alcohol and methylene blue, to determine the presence of acid fast microorganisms. This acid fast staining technique requires heating during the primary staining step involving the carbol fuchsin.

Radiography

C85831

ZIEHL NEELSEN ACID FAST STAIN

Ziehl Neelsen Acid Fast Staining Method

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CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86077 C86078 C86079 C86080

CDISC Submission Value ABIOTROPHIA ABIOTROPHIA DEFECTIVA ACHROMOBACTER ACHROMOBACTER DENITRIFICANS ACHROMOBACTER PIECHAUDII ACHROMOBACTER XYLOSOXIDANS ACIDAMINOCOCCUS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Abiotrophia genus level. Any bacterial organism that can be assigned to the species Abiotrophia defectiva. Any bacteria that is not assigned to the species level but can be assigned to the Achromobacter genus level.

NCI Preferred Term Abiotrophia Abiotrophia defectiva Achromobacter Achromobacter denitrificans

ALCALIGENES DENITRIFICAN S

Any bacterial organism that can be assigned to the species Achromobacter denitrificans. Any bacterial organism that can be assigned to the species Achromobacter piechaudii.

C86081 C86082

Achromobacter piechaudii Achromobacter xylosoxidans

ALCALIGENES Any bacterial organism that can be assigned to the XYLOSOXIDAN species Achromobacter xylosoxidans. S Any bacteria that is not assigned to the species level but can be assigned to the Acidaminococcus genus level. Any bacterial organism that can be assigned to the species Acidaminococcus fermentans. Any bacteria that is not assigned to the species level but can be assigned to the Acidovorax genus level. Any bacterial organism that can be assigned to the species Acidovorax delafieldii. Any bacterial organism that can be assigned to the species Acidovorax facilis. Any bacterial organism that can be assigned to the species Acidovorax temperans. Any bacteria that is not assigned to the species level but can be assigned to the Acinetobacter genus level. ACINETOBACT ER BAUMANNII; ACINETOBACT ER CALCOACETIC US SUBSP. ANITRATUS Any bacterial organism that can be assigned to the species Acinetobacter anitratus.

C86083

Acidaminococcus

C86084 C86085 C86086 C86087 C86088 C76200 C86089

ACIDAMINOCOCCUS FERMENTANS ACIDOVORAX ACIDOVORAX DELAFIELDII ACIDOVORAX FACILIS ACIDOVORAX TEMPERANS ACINETOBACTER ACINETOBACTER ANITRATUS

Acidaminococcus fermentans Acidovorax Acidovorax delafieldii Acidovorax facilis Acidovorax temperans Acinetobacter Acinetobacter anitratus

C86090 C86091

ACINETOBACTER CALCOACETICUS ACINETOBACTER CALCOACETICUS-BAUMA NNII COMPLEX ACINETOBACTER HAEMOLYTICUS ACINETOBACTER JOHNSONII

Any bacterial organism that can be assigned to the species Acinetobacter calcoaceticus. A non-taxonomic grouping of bacteria assigned to the Acinetobacter genus that include the A. calcoaceticus and A. baumannii species. Any bacterial organism that can be assigned to the species Acinetobacter haemolyticus. Any bacterial organism that can be assigned to the species Acinetobacter johnsonii.

Acinetobacter calcoaceticus Acinetobacter calcoaceticus/baumannii Complex Acinetobacter haemolyticus Acinetobacter johnsonii

C86092 C86093

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 264 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86094 C86095

CDISC Submission Value ACINETOBACTER JUNII

CDISC Definition Any bacterial organism that can be assigned to the species Acinetobacter junii. Any bacterial organism that can be assigned to the species Acinetobacter lwoffii.

NCI Preferred Term Acinetobacter junii Acinetobacter lwoffii

ACINETOBACTER LWOFFII ACINETOBACT ER CALCOACETIC US SUBSP. LWOFFII ACINETOBACTER RADIORESISTENS ACTINOBACILLUS ACTINOBACILLUS CDC GROUP ACTINOMYCETEMCOMITA HB-3 NS ACTINOBACILLUS EQUULI ACTINOBACILLUS LIGNIERESII ACTINOBACILLUS PLEUROPNEUMONIAE ACTINOBACILLUS SUIS ACTINOBACILLUS UREAE ACTINOMADURA ACTINOMADURA MADURAE ACTINOMADURA PELLETIERI ACTINOMYCES PASTEURELLA UREAE

C86096 C86097 C86098

Any bacterial organism that can be assigned to the species Acinetobacter radioresistens. Any bacteria that is not assigned to the species level but can be assigned to the Actinobacillus genus level. Any bacterial organism that can be assigned to the species Actinobacillus actinomycetemcomitans. Any bacterial organism that can be assigned to the species Actinobacillus equuli. Any bacterial organism that can be assigned to the species Actinobacillus ligniersii. HAEMOPHILUS Any bacterial organism that can be assigned to the PLEUROPNEU species Actinobacillus pleuropneumoniae. MONIAE Any bacterial organism that can be assigned to the species Actinobacillus suis. Any bacterial organism that can be assigned to the species Actinobacillus ureae. Any bacteria that is not assigned to the species level but can be assigned to the Actinomadura genus level. Any bacterial organism that can be assigned to the species Actinomadura madurae. Any bacterial organism that can be assigned to the species Actinomadura pelletieri. Any bacteria that is not assigned to the species level but can be assigned to the Actinomyces genus level.

Acinetobacter radioresistens Actinobacillus Actinobacillus actinomycetemcomitans Actinobacillus equuli Actinobacillus ligniersii Actinobacillus pleuropneumoniae

C86099 C86100 C86101

C86102 C86103 C86104 C86105 C86106 C76201

Actinobacillus suis Actinobacillus ureae Actinomadura Actinomadura madurae Actinomadura pelletieri Actinomyces

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 265 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86107

CDISC Submission Value ACTINOMYCES BOVIS

CDISC Definition

NCI Preferred Term Actinomyces bovis

PROACTINOMY Any bacterial organism that can be assigned to the CES BOVIS; species Actinomyces bovis. SPHAEROTILU S BOVIS; CLADOTHRIX BOVIS; STREPTOTHRIX BOVIS; NOCARDIA BOVIS; ACTINOCLADO THRIX BOVIS; OOSPORA BOVIS; SARCOMYCES BOVIS; DISCOMYCES BOVIS Any bacterial organism that can be assigned to the species Actinomyces israelii. Any bacterial organism that can be assigned to the species Actinomyces meyerii. Any bacterial organism that can be assigned to the species Actinomyces naseslundii. Any bacterial organism that can be assigned to the species Actinomyces neuii. Any bacterial organism that can be assigned to the species Actinomyces odontolyticus. Any bacterial organism that can be assigned to the species Actinomyces radingae. Any bacterial organism that can be assigned to the species Actinomyces turicensis. Any bacterial organism that can be assigned to the species Actinomyces viscosus. AEROBIC GRAM-NEGATI VE ROD Any rod-shaped bacteria with an oxygen-based metabolism and has a cell wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique. Any spherical-shaped bacteria with an oxygen-based metabolism and a cell wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique. AEROBIC Any rod-shaped bacteria with an oxygen-based GRAM-POSITIV metabolism and has a peptidoglycan-rich cell wall that E ROD stains dark purple with the Gram staining technique. Any spherical-shaped bacteria with an oxygen-based metabolism and a peptidoglycan-rich cell wall that stains dark purple with the Gram staining technique. Any bacteria assigned to the genus Streptococcus that requires oxygen to grow or respirate.

C86108 C86109 C86110 C86111 C86112 C86113 C86114 C86115 C86116

ACTINOMYCES ISRAELII ACTINOMYCES MEYERII ACTINOMYCES NAESLUNDII ACTINOMYCES NEUII ACTINOMYCES ODONTOLYTICUS ACTINOMYCES RADINGAE ACTINOMYCES TURICENSIS ACTINOMYCES VISCOSUS AEROBIC GRAM-NEGATIVE BACILLUS AEROBIC GRAM-NEGATIVE COCCUS

Actinomyces israelii Actinomyces meyerii Actinomyces naseslundii Actinomyces neuii Actinomyces odontolyticus Actinomyces radingae Actinomyces turicensis Actinomyces viscosus Aerobic Gram Negative Bacillus

C86117

Aerobic Gram Negative Coccus

C86118

AEROBIC GRAM-POSITIVE BACILLUS AEROBIC GRAM-POSITIVE COCCUS AEROBIC STREPTOCOCCUS

Aerobic Gram Positive Bacillus

C86119

Aerobic Gram Positive Coccus

C86120

Aerobic Streptococcus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 266 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym GAFFKYA SPECIES

NCI Code C86121 C86122 C86123 C86124 C86125

CDISC Submission Value AEROCOCCUS AEROCOCCUS URINAE AEROCOCCUS VIRIDANS AEROMONAS AEROMONAS HYDROPHILA AEROMONAS JANDAEI AEROMONAS PUNCTATA AEROMONAS SALMONICIDA AEROMONAS SCHUBERTII AEROMONAS SOBRIA AEROMONAS VERONII AGGREGATIBACTER

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Aerococcus genus level. Any bacterial organism that can be assigned to the species Aerococcus urinae. Any bacterial organism that can be assigned to the species Aerococcus viridans. Any bacteria that is not assigned to the species level but can be assigned to the Aeromonas genus level.

NCI Preferred Term Aerococcus Aerococcus urinae Aerococcus viridans Aeromonas Aeromonas hydrophila

AEROMONAS HYDROPHILA GROUP

Any bacterial organism that can be assigned to the species Aeromonas hydrophila. Any bacterial organism that can be assigned to the species Aeromonas jandaei.

C86126 C86127 C86128 C86129 C86130 C86131 C86132 C86133

Aeromonas jandaei Aeromonas punctata Aeromonas salmonicida Aeromonas schubertii Aeromonas sobria Aeromonas veronii Aggregatibacter Aggregatibacter actinomycetemcomitans Aggregatibacter aphrophilus

AEROMONAS CAVIAE

Any bacterial organism that can be assigned to the species Aeromonas punctata. Any bacterial organism that can be assigned to the species Aeromonas salmonicida. Any bacterial organism that can be assigned to the species Aeromonas schubertii. Any bacterial organism that can be assigned to the species Aeromonas sobria. Any bacterial organism that can be assigned to the species Aeromonas veronii. Any bacteria that is not assigned to the species level but can be assigned to the Aggregatibacter genus level.

AGGREGATIBACTER HAEMOPHILUS Any bacterial organism that can be assigned to the ACTINOMYCETEMCOMITA ACTINOMYCET species Aggregatibacter actinomycetemcomitans. NS EMCOMITANS AGGREGATIBACTER APHROPHILUS CDC GROUP Any bacterial organism that can be assigned to the HB-2; species Aggregatibacter aphrophilus. HAEMOPHILUS PARAPHROPHI LUS; BETA-LACTAM ASE NEGATIVE HAEMOPHILUS PARAPHROPHI LUS; HAEMOPHILUS APHROPHILUS HAEMOPHILUS Any bacterial organism that can be assigned to the SEGNIS species Aggregatibacter segnis. Any bacteria that is not assigned to the species level but can be assigned to the Agrobacterium genus level. Any bacterial organism that can be assigned to the species Agrobacterium radiobacter.

C86134

C86135 C86011 C86137

AGGREGATIBACTER SEGNIS AGROBACTERIUM AGROBACTERIUM RADIOBACTER

Aggregatibacter segnis Agrobacterium Agrobacterium radiobacter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 267 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym CDC GROUP VD-3; RHIZOBIUM RADIOBACTER

NCI Code C86138

CDISC Submission Value AGROBACTERIUM TUMEFACIENS

CDISC Definition Any bacterial organism that can be assigned to the species Agrobacterium tumefaciens.

NCI Preferred Term Agrobacterium tumefaciens

C86012 C86140 C86871 C86142

ALCALIGENES ALCALIGENES FAECALIS ALISTIPES PUTREDINIS ANAEROBIC GRAM-NEGATIVE BACILLUS ANAEROBIC GRAM-NEGATIVE COCCUS ALCALIGENES ODORANS BACTEROIDES PUTREDINIS ANAEROBIC GRAM-NEGATI VE ROD

Any bacteria that is not assigned to the species level but can be assigned to the Alcaligenes genus level. Any bacterial organism that can be assigned to the species Alcaligenes faecalis. Any bacterial organism that can be assigned to the species Alistipes putredinis. Any rod-shaped bacteria that does not require oxygen to grow or respirate and has a cell wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique. Any spherical-shaped bacteria that does not require oxygen to grow or respirate and has a cell wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique.

Alcaligenes Alcaligenes faecalis Alistipes putredinis Anaerobic Gram Negative Bacillus

C86143

Anaerobic Gram Negative Coccus

C86144

ANAEROBIC ANAEROBIC Any rod-shaped bacteria that does not require oxygen GRAM-POSITIVE BACILLUS GRAM-POSITIV to grow or respirate and has a peptidoglycan-rich cell E ROD wall that stains dark purple with the Gram staining technique. ANAEROBIC GRAM-POSITIVE COCCUS Any spherical-shaped bacteria that does not require oxygen to grow or respirate and has a peptidoglycan-rich cell wall that stains dark purple with the Gram staining technique. Any bacteria assigned to the genus Streptococcus that does not require oxygen to grow or respirate. Any bacteria that is not assigned to the species level but can be assigned to the Anaerococcus genus level. PEPTOSTREPT Any bacterial organism that can be assigned to the OCOCCUS species Anaerococcus hydrogenalis. HYDROGENALI S Any bacterial organism that can be assigned to the species Anaerococcus prevotii. GAFFKYA ANAEROBIA; PEPTOSTREPT OTOCCUS TETRADIUS Any bacterial organism that can be assigned to the species Anaerococcus tetradius.

Anaerobic Gram Positive Bacillus

C86145

Anaerobic Gram Positive Coccus

C86146 C86872 C86874

ANAEROBIC STREPTOCOCCUS ANAEROCOCCUS ANAEROCOCCUS HYDROGENALIS

Anaerobic Streptococcus Anaerococcus Anaerococcus hydrogenalis

C86875 C86876

ANAEROCOCCUS PREVOTII ANAEROCOCCUS TETRADIUS

Anaerococcus prevotii Anaerococcus tetradius

C86877 C86147

ANAEROCOCCUS VAGINALIS ARCANOBACTERIUM

Any bacterial organism that can be assigned to the species Anaerococcus vaginalis. Any bacteria that is not assigned to the species level but can be assigned to the Arcanobacterium genus level. Any bacterial organism that can be assigned to the species Arcanobacterium bernardiae.

Anaerococcus vaginalis Arcanobacterium

C86148

ARCANOBACTERIUM BERNARDIAE

Arcanobacterium bernardiae

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 268 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86149

CDISC Submission Value ARCANOBACTERIUM HAEMOLYTICUM

CDISC Definition

NCI Preferred Term Arcanobacterium haemolyticum

CORYNEBACTE Any bacterial organism that can be assigned to the RIUM species Arcanobacterium haemolyticum. HAEMOLYTICU M; CORYNEBACTE RIUM HAEMOLYTICU S ACTINOMYCES Any bacterial organism that can be assigned to the PYOGENES; species Arcanobacterium pyogenes. CORYNEBACTE RIUM PYOGENES Any bacteria that is not assigned to the species level but can be assigned to the Arcobacter genus level. CAMPYLOBAC TER BUTZLERI CAMPYLOBAC TER CRYAEROPHIL US Any bacterial organism that can be assigned to the species Arcobacter butzleri. Any bacterial organism that can be assigned to the species Arcobacter cryaerophilus.

C86150

ARCANOBACTERIUM PYOGENES

Arcanobacterium pyogenes

C86152 C86153 C86154

ARCOBACTER ARCOBACTER BUTZLERI ARCOBACTER CRYAEROPHILUS

Arcobacter Arcobacter butzleri Arcobacter cryaerophilus

C86155 C86156

ARTHROBACTER ATOPOBIUM MINUTUM LACTOBACILL US MINUTIS; LACTOBACILL US MINUTUS STREPTOCOCC US PARVULUS

Any bacteria that is not assigned to the species level but can be assigned to the Arthrobacter genus level. Any bacterial organism that can be assigned to the species Atopobium minutum.

Arthrobacter Atopobium minutum

C86157 C86158

ATOPOBIUM PARVULUM AVIBACTERIUM PARAGALLINARUM BACILLUS BACILLUS ALVEI BACILLUS ANTHRACIS BACILLUS CEREUS BACILLUS LENTUS BACILLUS LICHENIFORMIS BACILLUS MEGATERIUM BACILLUS MYCOIDES

Any bacterial organism that can be assigned to the species Atopobium parvulum.

Atopobium parvulum Avibacterium paragallinarum

HAEMOPHILUS Any bacterial organism that can be assigned to the PARAGALLINA species Avibacterium paragallinarum. RUM Any bacteria that is not assigned to the species level but can be assigned to the Bacillus genus level. Any bacterial organism that can be assigned to the species Bacillus alvei. Any bacterial organism that can be assigned to the species Bacillus anthracis. Any bacterial organism that can be assigned to the species Bacillus cereus. Any bacterial organism that can be assigned to the species Bacillus lentus. Any bacterial organism that can be assigned to the species Bacillus licheniformis. Any bacterial organism that can be assigned to the species Bacillus megaterium. Any bacterial organism that can be assigned to the species Bacillus mycoides.

C76202 C86159 C86160 C86161 C86162 C86163 C86164 C86165

Bacillus Bacillus alvei Bacillus anthracis Bacillus cereus Bacillus lentus Bacillus licheniformis Bacillus megaterium Bacillus mycoides

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 269 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86166 C86167 C14187 C76204 C86168

CDISC Submission Value BACILLUS POLYMYXA BACILLUS SUBTILIS BACTERIA BACTEROIDES BACTEROIDES CACCAE

CDISC Definition Any bacterial organism that can be assigned to the species Bacillus polymyxa. Any bacterial organism that can be assigned to the species Bacillus subtilis.

NCI Preferred Term Bacillus polymyxa Bacillus subtilis Bacteria Bacteroides Bacteroides caccae

BACTERIUM; EUBACTERIA

Any organism assigned to the kingdom Bacteria. Any bacteria that is not assigned to the species level but can be assigned to the Bacteroides genus level.

BACTEROIDES FRAGILIS GROUP 3452A

Any bacterial organism that can be assigned to the species Bacteroides caccae. Any bacterial organism that can be assigned to the species Bacteroides capillosus. Any bacterial organism that can be assigned to the species Bacteroides cellulosolvens. Any bacterial organism that can be assigned to the species Bacteroides eggerthii. Any bacterial organism that can be assigned to the species Bacteroides fragilis. A bacteria that belongs to the Fragilis group of the genus Bacteroides. Any bacterial organism that can be assigned to the species Bacteroides nordii. Any bacterial organism that can be assigned to the species Bacteroides ovatus. Any bacterial organism that can be assigned to the species Bacteroides splanchnicus.

C86169 C86170 C86171 C86172 C86173 C86174 C86175 C86176 C86177

BACTEROIDES CAPILLOSUS BACTEROIDES CELLULOSOLVENS BACTEROIDES EGGERTHII BACTEROIDES FRAGILIS BACTEROIDES FRAGILIS GROUP BACTEROIDES NORDII BACTEROIDES OVATUS BACTEROIDES SPLANCHNICUS BACTEROIDES STERCORIS BACTEROIDES FRAGILIS SUBSP. A BACTEROIDES TECTUM

Bacteroides capillosus Bacteroides cellulosolvens Bacteroides eggerthii Bacteroides fragilis Bacteroides fragilis Group Bacteroides nordii Bacteroides ovatus Bacteroides splanchnicus Bacteroides stercoris

Any bacterial organism that can be assigned to the species Bacteroides stercoris. Any bacterial organism that can be assigned to the species Bacteroides tectus. Any bacterial organism that can be assigned to the species Bacteroides thetaiotamicron. Any bacterial organism that can be assigned to the species Bacteroides uniformis.

C86178 C86179 C86180 C86181 C86182 C86184 C86185

BACTEROIDES TECTUS BACTEROIDES THETAIOTAOMICRON BACTEROIDES UNIFORMIS BACTEROIDES UREOLYTICUS BACTEROIDES VULGATUS BARTONELLA BARTONELLA ELIZABETHAE

Bacteroides tectus Bacteroides thetaiotamicron Bacteroides uniformis Bacteroides ureolyticus Bacteroides vulgatus Bartonella Bartonella elizabethae

BACTEROIDES CORRODENS

Any bacterial organism that can be assigned to the species Bacteroides ureolyticus. Any bacterial organism that can be assigned to the species Bacteroides vulgatus. Any bacteria that is not assigned to the species level but can be assigned to the Bartonella genus level.

ROCHALIMAEA Any bacterial organism that can be assigned to the ELIZABETHAE species Bartonella elizabethae.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 270 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86186 C86187 C86188 C86189 C86191

CDISC Submission Value BARTONELLA HENSELAE BARTONELLA QUINTANA BERGEYELLA BERGEYELLA ZOOHELCUM BETA STREPTOCOCCUS, GROUP C BETA STREPTOCOCCUS, GROUP F BETA STREPTOCOCCUS, GROUP G BIFIDOBACTERIUM BIFIDOBACTERIUM ADOLESCENTIS BIFIDOBACTERIUM ANGULATUM BIFIDOBACTERIUM BIFIDUM BIFIDOBACTERIUM DENTIUM BIFIDOBACTERIUM LONGUM BILOPHILA BILOPHILA WADSWORTHIA BORDETELLA BORDETELLA AVIUM BORDETELLA BRONCHISEPTICA BORDETELLA PARAPERTUSSIS BORDETELLA PERTUSSIS

CDISC Definition

NCI Preferred Term Bartonella henselae Bartonella quintana Bergeyella Bergeyella zoohelcum Beta Streptococcus Group C

ROCHALIMAEA Any bacterial organism that can be assigned to the HENSELAE species Bartonella henselae. ROCHALIMAEA Any bacterial organism that can be assigned to the QUINTANA species Bartonella quintana. Any bacteria that is not assigned to the species level but can be assigned to the Bergeyella genus level. WEEKSELLA ZOOHELCUM Any bacterial organism that can be assigned to the species Bergeyella zoohelcum. A non-taxonomic grouping of beta-hemolytic species within the Streptococcus genus that are assigned to the C group. A non-taxonomic grouping of beta-hemolytic species within the Streptococcus genus that are assigned to the F group. A non-taxonomic grouping of beta-hemolytic species within the Streptococcus genus that are assigned to the G group. Any bacteria that is not assigned to the species level but can be assigned to the Bifidobacterium genus level. Any bacterial organism that can be assigned to the species Bifidobacterium adolescentis. Any bacterial organism that can be assigned to the species Bifidobacterium angulatum. Any bacterial organism that can be assigned to the species Bifidobacterium bifidum. BIFIDOBACTER Any bacterial organism that can be assigned to the IUM species Bifidobacterium dentium. APPENDICITIS Any bacterial organism that can be assigned to the species Bifidobacterium longum. Any bacteria that is not assigned to the species level but can be assigned to the Bilophila genus level. Any bacterial organism that can be assigned to the species Bilophila wadsworthia. Any bacteria that is not assigned to the species level but can be assigned to the Bordetella genus level. Any bacterial organism that can be assigned to the species Bordetella avium. BORDETELLA BRONCHICANI S Any bacterial organism that can be assigned to the species Bordetella bronchiseptica. Any bacterial organism that can be assigned to the species Bordetella parapertussis. Any bacterial organism that can be assigned to the species Bordetella pertussis.

C86192

Beta Streptococcus Group F

C86193

Beta Streptococcus Group G

C86194 C86195 C86196 C86197 C86198

Bifidobacterium Bifidobacterium adolescentis Bifidobacterium angulatum Bifidobacterium bifidum Bifidobacterium dentium

C86199 C86200 C86201 C86202 C86203 C86204

Bifidobacterium longum Bilophila Bilophila wadsworthia Bordetella Bordetella avium Bordetella bronchiseptica

C86205 C76205

Bordetella parapertussis Bordetella pertussis

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 271 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86206 C76208 C86207 C86208 C86209 C86210 C86211 C86212 C86213 C86214 C86215 C86216 C86217 C86218 C86219 C86220 C86221 C86222 C86223 C76376

CDISC Submission Value BORRELIA BORRELIA BURGDORFERI BREVIBACILLUS BREVIBACILLUS LATEROSPORUS BREVIBACTERIUM BREVIBACTERIUM CASEI BREVIBACTERIUM EPIDERMIDIS BREVUNDIMONAS BREVUNDIMONAS DIMINUTA BREVUNDIMONAS VESICULARIS BRUCELLA BRUCELLA ABORTUS BRUCELLA CANIS BRUCELLA MELITENSIS BRUCELLA SUIS BUDVICIA BUDVICIA AQUATICA BURKHOLDERIA BURKHOLDERIA CENOCEPACIA BURKHOLDERIA CEPACIA

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Borrelia genus level. Any bacterial organism that can be assigned to the species Borrelia burgdorferi. Any bacteria that is not assigned to the species level but can be assigned to the Brevibacillus genus level. Any bacterial organism that can be assigned to the species Brevibacillus laterosporus. Any bacteria that is not assigned to the species level but can be assigned to the Brevibacterium genus level. Any bacterial organism that can be assigned to the species Brevibacterium casei. Any bacterial organism that can be assigned to the species Brevibacterium epidermidis. Any bacteria that is not assigned to the species level but can be assigned to the Brevundimonas genus level.

NCI Preferred Term Borrelia Borrelia burgdorferi Brevibacillus Brevibacillus laterosporus Brevibacterium Brevibacterium casei Brevibacterium epidermidis Brevundimonas Brevundimonas diminuta Brevundimonas vesicularis Brucella Brucella abortus Brucella canis Brucella melitensis Brucella suis Budvicia Budvicia aquatica Burkholderia Burkholderia cenocepacia Burkholderia cepacia

PSEUDOMONA S DIMINUTA

Any bacterial organism that can be assigned to the species Brevundimonas diminuta.

PSEUDOMONA Any bacterial organism that can be assigned to the S VESICULARIS species Brevundimonas vesicularis. Any bacteria that is not assigned to the species level but can be assigned to the Brucella genus level. Any bacterial organism that can be assigned to the species Brucella abortus. Any bacterial organism that can be assigned to the species Brucella canis. Any bacterial organism that can be assigned to the species Brucella melitensis. Any bacterial organism that can be assigned to the species Brucella suis. Any bacteria that is not assigned to the species level but can be assigned to the Budvicia genus level. Any bacterial organism that can be assigned to the species Budvicia aquatica. Any bacteria that is not assigned to the species level but can be assigned to the Burkholderia genus level. Any bacterial organism that can be assigned to the species Burkholderia cenocepacia. PSEUDOMONA S CEPACIA; CDC GROUP EO-1 Any bacterial organism that can be assigned to the species Burkholderia cepacia.

C86224

BURKHOLDERIA CEPACIA COMPLEX

A non-taxonomic grouping of bacteria assigned to and including at least nine related species from the Burkholderia genus.

Burkholderia cepacia Complex

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 272 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym PSEUDOMONA S GLADIOLI

NCI Code C86225 C86226 C86227

CDISC Submission Value BURKHOLDERIA GLADIOLI BURKHOLDERIA MALLEI BURKHOLDERIA PSEUDOMALLEI

CDISC Definition Any bacterial organism that can be assigned to the species Burkholderia gladioli.

NCI Preferred Term Burkholderia gladioli Burkholderia mallei Burkholderia pseudomallei

ACTINOBACILL Any bacterial organism that can be assigned to the US MALLEI species Burkholderia mallei. PSEUDOMONA Any bacterial organism that can be assigned to the S species Burkholderia pseudomallei. PSEUDOMALL EI; BURKHOLDERI A PSEUDOMALL E Any bacteria that is not assigned to the species level but can be assigned to the Buttiauxella genus level. Any bacterial organism that can be assigned to the species Buttiauxella agrestis. Any bacteria that is not assigned to the species level but can be assigned to the Campylobacter genus level. Any bacterial organism that can be assigned to the species Campylobacter coli. CDC GROUP EF-22 WOLINELLA CURVA VIBRIO FETUS BACTEROIDES GRACILIS Any bacterial organism that can be assigned to the species Campylobacter concisus. Any bacterial organism that can be assigned to the species Campylobacter curvus. Any bacterial organism that can be assigned to the species Campylobacter fetus. Any bacterial organism that can be assigned to the species Campylobacter gracilis. Any bacterial organism that can be assigned to the species Campylobacter jejuni. CAMPYLOBAC TER LARIDIS Any bacterial organism that can be assigned to the species Campylobacter lari. Any bacterial organism that can be assigned to the species Campylobacter rectus. Any bacterial organism that can be assigned to the species Campylobacter upsaliensis. Any bacteria that is not assigned to the species level but can be assigned to the Capnocytophaga genus level. CDC GROUP DF-2 Any bacterial organism that can be assigned to the species Capnocytophaga canimorsus. Any bacterial organism that can be assigned to the species Capnocytophaga gingivalis. Any bacterial organism that can be assigned to the species Capnocytophaga ochracea. Any bacterial organism that can be assigned to the species Capnocytophaga sputigena.

C86228 C86229 C76211 C86230 C86231 C86232 C86233 C86234 C86235 C86236 C86237 C86238 C76269 C86239 C86240 C86241 C86242

BUTTIAUXELLA BUTTIAUXELLA AGRESTIS CAMPYLOBACTER CAMPYLOBACTER COLI CAMPYLOBACTER CONCISUS CAMPYLOBACTER CURVUS CAMPYLOBACTER FETUS CAMPYLOBACTER GRACILIS CAMPYLOBACTER JEJUNI CAMPYLOBACTER LARI

Buttiauxella Buttiauxella agrestis Campylobacter Campylobacter coli Campylobacter concisus Campylobacter curvus Campylobacter fetus Campylobacter gracilis Campylobacter jejuni Campylobacter lari Campylobacter rectus Campylobacter upsaliensis Capnocytophaga Capnocytophaga canimorsus Capnocytophaga gingivalis Capnocytophaga ochracea Capnocytophaga sputigena

CAMPYLOBACTER RECTUS WOLINELLA RECTA CAMPYLOBACTER UPSALIENSIS CAPNOCYTOPHAGA CAPNOCYTOPHAGA CANIMORSUS CAPNOCYTOPHAGA GINGIVALIS CAPNOCYTOPHAGA OCHRACEA CAPNOCYTOPHAGA SPUTIGENA

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 273 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86243

CDISC Submission Value CARDIOBACTERIUM

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Cardiobacterium genus level.

NCI Preferred Term Cardiobacterium

C86244 C86245 C86246 C86247 C86248 C86249 C86250 C86251

CARDIOBACTERIUM HOMINIS CEDECEA CEDECEA DAVISAE CEDECEA LAPAGEI CEDECEA NETERI CELLULOMONAS CELLULOMONAS HOMINIS CELLULOSIMICROBIUM

CDC GROUP IID

Any bacterial organism that can be assigned to the species Cardiobacterium hominis. Any bacteria that is not assigned to the species level but can be assigned to the Cedecea genus level.

Cardiobacterium hominis Cedecea Cedecea davisae Cedecea lapagei Cedecea neteri Cellulomonas Cellulomonas hominis Cellulosimicrobium

CDC ENTERIC GROUP 15

Any bacterial organism that can be assigned to the species Cedecea davisae. Any bacterial organism that can be assigned to the species Cedecea lapagei.

CEDECEA SPECIES 4

Any bacterial organism that can be assigned to the species Cedecea neteri. Any bacteria that is not assigned to the species level but can be assigned to the Cellulomonas genus level. Any bacterial organism that can be assigned to the species Cellulomonas hominis. Any bacteria that is not assigned to the species level but can be assigned to the Cellulosimicrobium genus level.

C86252

CELLULOSIMICROBIUM CELLULANS

OERSKOVIA Any bacterial organism that can be assigned to the XANTHINEOLY species Cellulosimicrobium cellulans. TICA; ARTHROBACTE R LUTEUS; CELLULOMON AS CELLULANS; NOCARDIA CELLULANS Any bacteria that is not assigned to the species level but can be assigned to the Chlamydia genus level. Any bacterial organism that can be assigned to the species Chlamydia trachomatis. Any bacteria that is not assigned to the species level but can be assigned to the Chlamydophila genus level. CHLAMYDIA PNEUMONIAE CHLAMYDIA PSITTACI Any bacterial organism that can be assigned to the species Chlamydophila pneumoniae. Any bacterial organism that can be assigned to the species Chlamydophila psittaci. Any bacteria that is not assigned to the species level but can be assigned to the Chromobacterium genus level. Any bacterial organism that can be assigned to the species Chromobacterium violaceum. Any bacteria that is not assigned to the species level but can be assigned to the Chryseobacterium genus level.

Cellulosimicrobium cellulans

C76271 C86253 C86254 C76272 C86255 C86256

CHLAMYDIA CHLAMYDIA TRACHOMATIS CHLAMYDOPHILA CHLAMYDOPHILA PNEUMONIAE CHLAMYDOPHILA PSITTACI CHROMOBACTERIUM

Chlamydia Chlamydia trachomatis Chlamydophila Chlamydophila pneumoniae Chlamydophila psittaci Chromobacterium

C86257 C86258

CHROMOBACTERIUM VIOLACEUM CHRYSEOBACTERIUM

Chromobacterium violaceum Chryseobacterium

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 274 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86259 C86260

CDISC Submission Value CHRYSEOBACTERIUM GLEUM CHRYSEOBACTERIUM INDOLOGENES CHRYSEOMONAS CITROBACTER CITROBACTER AMALONATICUS CITROBACTER BRAAKII CITROBACTER FARMERI

CDISC Definition

NCI Preferred Term Chryseobacterium gleum Chryseobacterium indologenes

FLAVOBACTER Any bacterial organism that can be assigned to the IUM GLEUM species Chryseobacterium gleum. FLAVOBACTER Any bacterial organism that can be assigned to the IUM species Chryseobacterium indologenes. INDOLOGENES Any bacteria that is not assigned to the species level but can be assigned to the Chryseomonas genus level. Any bacteria that is not assigned to the species level but can be assigned to the Citrobacter genus level. LEVINEA Any bacterial organism that can be assigned to the AMALONATICA species Citrobacter amalonaticus. Any bacterial organism that can be assigned to the species Citrobacter braakii. CITROBACTER Any bacterial organism that can be assigned to the AMALONATICU species Citrobacter farmeri. S BIOGROUP 1 COLOBACTRU M FREUNDII Any bacterial organism that can be assigned to the species Citrobacter freundii. A non-taxonomic grouping of bacteria assigned to and including eight related species from the Citrobacter genus. CITROBACTER DIVERSUS Any bacterial organism that can be assigned to the species Citrobacter koseri. Any bacterial organism that can be assigned to the species Citrobacter youngae. Any bacteria that is not assigned to the species level but can be assigned to the Clostridium genus level. Any bacterial organism that can be assigned to the species Clostridium acetobutylicum. CLOSTRIDIUM BARATI Any bacterial organism that can be assigned to the species Clostridium baratii. Any bacterial organism that can be assigned to the species Clostridium beijerinckii. Any bacterial organism that can be assigned to the species Clostridium bifermentans. CLOSTRIDIUM Any bacterial organism that can be assigned to the PSEUDOTETAN species Clostridium butyricum. ICUM Any bacterial organism that can be assigned to the species Clostridium cadaveris. Any bacterial organism that can be assigned to the species Clostridium celatum. CLOSTRIDIUM CLOSTRIDIIFO RME Any bacterial organism that can be assigned to the species Clostridium clostridioforme.

C86261 C76273 C86262 C86263 C86264

Chryseomonas Citrobacter Citrobacter amalonaticus Citrobacter braakii Citrobacter farmeri

C86265 C86266

CITROBACTER FREUNDII CITROBACTER FREUNDII COMPLEX CITROBACTER KOSERI CITROBACTER YOUNGAE CLOSTRIDIUM CLOSTRIDIUM ACETOBUTYLICUM CLOSTRIDIUM BARATII CLOSTRIDIUM BEIJERINCKII CLOSTRIDIUM BIFERMENTANS CLOSTRIDIUM BUTYRICUM CLOSTRIDIUM CADAVERIS CLOSTRIDIUM CELATUM CLOSTRIDIUM CLOSTRIDIOFORME

Citrobacter freundii Citrobacter freundii Complex

C86267 C86268 C76275 C86269 C86270 C86271 C86272 C86273

Citrobacter koseri Citrobacter youngae Clostridium Clostridium acetobutylicum Clostridium baratii Clostridium beijerinckii Clostridium bifermentans Clostridium butyricum

C86274 C86275 C86276

Clostridium cadaveris Clostridium celatum Clostridium clostridioforme

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 275 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86277 C86278 C76276 C86279

CDISC Submission Value CLOSTRIDIUM COCHLEARIUM CLOSTRIDIUM COCLEATUM CLOSTRIDIUM DIFFICILE CLOSTRIDIUM FALLAX

CDISC Definition Any bacterial organism that can be assigned to the species Clostridium cochlearium. Any bacterial organism that can be assigned to the species Clostridium cocleatum.

NCI Preferred Term Clostridium cochlearium Clostridium cocleatum Clostridium difficile Clostridium fallax

CLOSTRIDIUM DIFFICILIS CLOSTRIDIUM PSEUDOFALLA X

Any bacterial organism that can be assigned to the species Clostridium difficile. Any bacterial organism that can be assigned to the species Clostridium fallax. Any bacterial organism that can be assigned to the species Clostridium glycolicum. Any bacterial organism that can be assigned to the species Clostridium haemolyticum. Any bacterial organism that can be assigned to the species Clostridium histolyticum. Any bacterial organism that can be assigned to the species Clostridium innocuum.

C86280 C86281 C86282 C86283 C86284

CLOSTRIDIUM GLYCOLICUM CLOSTRIDIUM HAEMOLYTICUM CLOSTRIDIUM HISTOLYTICUM CLOSTRIDIUM INNOCUUM CLOSTRIDIUM LIMOSUM CLOSTRIDIUM SPECIES CDC GROUP P-1

Clostridium glycolicum Clostridium haemolyticum Clostridium histolyticum Clostridium innocuum Clostridium limosum

Any bacterial organism that can be assigned to the species Clostridium limosum. Any bacterial organism that can be assigned to the species Clostridium novyi. Any bacterial organism that can be assigned to the species Clostridium oceanicum. Any bacterial organism that can be assigned to the species Clostridium paraputrificum.

C86285 C86286 C86287 C86288 C86289

CLOSTRIDIUM NOVYI CLOSTRIDIUM OCEANICUM CLOSTRIDIUM PARAPUTRIFICUM CLOSTRIDIUM PERFRINGENS CLOSTRIDIUM PUTRIFICUM CLOSTRIDIUM RAMOSUM CLOSTRIDIUM RECTUM CLOSTRIDIUM SEPTICUM CLOSTRIDIUM SORDELLII CLOSTRIDIUM SPOROGENES CLOSTRIDIUM SUBTERMINALE CLOSTRIDIUM SYMBIOSUM BACTEROIDES SYMBIOSUS CLOSTRIDIUM WELCHII CLOSTRIDIUM LENTOPUTRES CENS

Clostridium novyi Clostridium oceanicum Clostridium paraputrificum Clostridium perfringens Clostridium putrificum

Any bacterial organism that can be assigned to the species Clostridium perfringens. Any bacterial organism that can be assigned to the species Clostridium putrificum.

C86290 C86291 C86292 C86293 C86294 C86295 C86296

ACTINOMYCES Any bacterial organism that can be assigned to the RAMOSUS species Clostridium ramosum. Any bacterial organism that can be assigned to the species Clostridium rectum. Any bacterial organism that can be assigned to the species Clostridium septicum. Any bacterial organism that can be assigned to the species Clostridium sordellii. Any bacterial organism that can be assigned to the species Clostridium sporogenes. Any bacterial organism that can be assigned to the species Clostridium subterminale. Any bacterial organism that can be assigned to the species Clostridium symbiosum.

Clostridium ramosum Clostridium rectum Clostridium septicum Clostridium sordellii Clostridium sporogenes Clostridium subterminale Clostridium symbiosum

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 276 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86297 C86298 C86299 C62584 C62585 C86300 C86301 C86302 C86303 C86304 C86305

CDISC Submission Value CLOSTRIDIUM TERTIUM CLOSTRIDIUM TETANI CLOSTRIDIUM TYROBUTYRICUM COAGULASE NEGATIVE STAPHYLOCOCCUS COAGULASE POSITIVE STAPHYLOCOCCUS COLLINSELLA COLLINSELLA AEROFACIENS COLLINSELLA INTESTINALIS COMAMONAS COMAMONAS TERRIGENA COMAMONAS TESTOSTERONI CORYNEBACTERIUM

CDISC Definition Any bacterial organism that can be assigned to the species Clostridium tertium. Any bacterial organism that can be assigned to the species Clostridium tetani. Any bacterial organism that can be assigned to the species Clostridium tyrobutyricum. Any bacteria assigned to the genus Staphylococcus that does not express the enzyme coagulase. Any bacteria assigned to the genus Staphylococcus that expresses the enzyme coagulase. Any bacteria that is not assigned to the species level but can be assigned to the Collinsella genus level.

NCI Preferred Term Clostridium tertium Clostridium tetani Clostridium tyrobutyricum Coagulase-Negative Staphylococcus Coagulase-Positive Staphylococcus Collinsella Collinsella aerofaciens Collinsella intestinalis Comamonas Comamonas terrigena Comamonas testosteroni

EUBACTERIUM Any bacterial organism that can be assigned to the AEROFACIENS species Collinsella aerofaciens. Any bacterial organism that can be assigned to the species Collinsella intestinalis. Any bacteria that is not assigned to the species level but can be assigned to the Comamonas genus level. CDC GROUP EF-19 Any bacterial organism that can be assigned to the species Comamonas terrigena.

PSEUDOMONA Any bacterial organism that can be assigned to the S species Comamonas testosteroni. TESTOSTERONI Any bacteria that is not assigned to the species level but can be assigned to the Corynebacterium genus level. CORYNEBACTE Any bacterial organism that can be assigned to the RIUM GROUP species Corynebacterium accolens. G-1 CORYNEBACTE Any bacterial organism that can be assigned to the RIUM ANF-1 species Corynebacterium afermentans. Any bacterial organism that can be assigned to the species Corynebacterium amycolatum. Any bacterial organism that can be assigned to the species Corynebacterium argentoratense. Any bacterial organism that can be assigned to the species Corynebacterium auris. Any bacterial organism that can be assigned to the species Corynebacterium bovis. Any bacterial organism that can be assigned to the species Corynebacterium diphtheriae. Any bacterial organism that can be assigned to the species Corynebacterium genitalium. Any bacterial organism that can be assigned to the species Corynebacterium glucuronolyticum.

C76308

Corynebacterium

C86306

CORYNEBACTERIUM ACCOLENS CORYNEBACTERIUM AFERMENTANS CORYNEBACTERIUM AMYCOLATUM CORYNEBACTERIUM ARGENTORATENSE CORYNEBACTERIUM AURIS CORYNEBACTERIUM BOVIS CORYNEBACTERIUM DIPHTHERIAE CORYNEBACTERIUM GENITALIUM CORYNEBACTERIUM GLUCURONOLYTICUM

Corynebacterium accolens

C86307 C86308 C86309 C86310 C86311 C86312 C86313 C86955

Corynebacterium afermentans Corynebacterium amycolatum Corynebacterium argentoratense Corynebacterium auris Corynebacterium bovis Corynebacterium diphtheriae Corynebacterium genitalium Corynebacterium glucuronolyticum

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 277 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C76307

CDISC Submission Value CORYNEBACTERIUM JEIKEIUM

CDISC Definition

NCI Preferred Term Corynebacterium jeikeium

CDC GROUP Any bacterial organism that can be assigned to the JK; species Corynebacterium jeikeium. CORYNEBACTE RIUM GROUP JK Any bacterial organism that can be assigned to the species Corynebacterium kutscheri. Any bacterial organism that can be assigned to the species Corynebacterium macginleyi. BACTERIONEM Any bacterial organism that can be assigned to the A species Corynebacterium matruchotii. MATRUCHOTII Any bacterial organism that can be assigned to the species Corynebacterium minutissimum. Any bacterial organism that can be assigned to the species Corynebacterium pilosum. Any bacterial organism that can be assigned to the species Corynebacterium propinquum. CORYNEBACTE Any bacterial organism that can be assigned to the RIUM species Corynebacterium pseudodiphtheriticum. HOFMANNII Any bacterial organism that can be assigned to the species Corynebacterium pseudotuberculosis. Any bacterial organism that can be assigned to the species Corynebacterium renale. Any bacterial organism that can be assigned to the species Corynebacterium striatum. Any bacterial organism that can be assigned to the species Corynebacterium ulcerans. CDC GROUP Any bacterial organism that can be assigned to the D2; species Corynebacterium urealyticum. CORYNEBACTE RIUM GROUP D-2 Any bacterial organism that can be assigned to the species Corynebacterium xerosis.

C86314 C86315 C86316

CORYNEBACTERIUM KUTSCHERI CORYNEBACTERIUM MACGINLEYI CORYNEBACTERIUM MATRUCHOTII CORYNEBACTERIUM MINUTISSIMUM CORYNEBACTERIUM PILOSUM CORYNEBACTERIUM PROPINQUUM CORYNEBACTERIUM PSEUDODIPHTHERITICUM CORYNEBACTERIUM PSEUDOTUBERCULOSIS CORYNEBACTERIUM RENALE CORYNEBACTERIUM STRIATUM CORYNEBACTERIUM ULCERANS CORYNEBACTERIUM UREALYTICUM

Corynebacterium kutscheri Corynebacterium macginleyi Corynebacterium matruchotii

C86317 C86318 C86319 C86320

Corynebacterium minutissimum Corynebacterium pilosum Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Corynebacterium pseudotuberculosis Corynebacterium renale Corynebacterium striatum Corynebacterium ulcerans Corynebacterium urealyticum

C86321 C86322 C86323 C86324 C86325

C86326 C86327

CORYNEBACTERIUM XEROSIS

Corynebacterium xerosis Coryneform Gram Positive Bacillus

CORYNEFORM CORYNEFORM Any bacteria whose shape is similar to those bacteria GRAM-POSITIVE BACILLUS GRAM-POSITIV assigned to the Corynebacterium genus and have a cell E ROD wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique. COXIELLA COXIELLA BURNETII CRONOBACTER SAKAZAKII Any bacteria that is not assigned to the species level but can be assigned to the Coxiella genus level. Any bacterial organism that can be assigned to the species Coxiella burnetii. ENTEROBACTE Any bacterial organism that can be assigned to the R SAKAZAKII species Cronobacter sakazakii.

C76309 C86328 C86329

Coxiella Coxiella burnetii Cronobacter sakazakii

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 278 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86330 C86331

CDISC Submission Value CUPRIAVIDUS CUPRIAVIDUS PAUCULUS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Cupriavidus genus level.

NCI Preferred Term Cupriavidus Cupriavidus pauculus

CDC GROUP IVC-2; WAUTERSIA PAUCULA; RALSTONIA PAUCULA

Any bacterial organism that can be assigned to the species Cupriavidus pauculus.

C86332 C86333

DELFTIA DELFTIA ACIDOVORANS

Any bacteria that is not assigned to the species level but can be assigned to the Delftia genus level. COMAMONAS Any bacterial organism that can be assigned to the ACIDOVORANS species Delftia acidovorans. ; PSEUDOMONA S ACIDOVORANS Any bacteria that is not assigned to the species level but can be assigned to the Dermabacter genus level. Any bacterial organism that can be assigned to the species Dermabacter hominis. MICROCOCCU Any bacterial organism that can be assigned to the S species Dermacoccus nishinomiyaensis. NISHINOMIYAE NSIS Any bacteria that is not assigned to the species level but can be assigned to the Dermatophilus genus level. Any bacterial organism that can be assigned to the species Dermatophilus congolensis. DESULFOMON AS SPECIES Any bacteria that is not assigned to the species level but can be assigned to the Desulfovibrio genus level. Any bacterial organism that can be assigned to the species Desulfovibrio desulfuricans. Any bacterial organism that can be assigned to the species Desulfovibrio fairfieldensis. DESULFOMON AS PIGRA Any bacterial organism that can be assigned to the species Desulfovibrio piger. Any of a number of rod-shaped bacteria that resemble Corynebacterium diphtheriae, either in morphology or etiology. Any bacteria that is not assigned to the species level but can be assigned to the Edwardsiella genus level. Any bacterial organism that can be assigned to the species Edwardsiella hoshinae. Any bacterial organism that can be assigned to the species Edwardsiella ictaluri. Any bacterial organism that can be assigned to the species Edwardsiella tarda.

Delftia Delftia acidovorans

C86334 C86335 C86336

DERMABACTER DERMABACTER HOMINIS DERMACOCCUS NISHINOMIYAENSIS

Dermabacter Dermabacter hominis Dermacoccus nishinomiyaensis

C86337 C86338 C86339 C86340 C86341 C86342 C86343

DERMATOPHILUS DERMATOPHILUS CONGOLENSIS DESULFOVIBRIO DESULFOVIBRIO DESULFURICANS DESULFOVIBRIO FAIRFIELDENSIS DESULFOVIBRIO PIGER DIPHTHEROID BACILLUS

Dermatophilus Dermatophilus congolensis Desulfovibrio Desulfovibrio desulfuricans Desulfovibrio fairfieldensis Desulfovibrio piger Diptheroid Bacillus

C86344 C86345 C86346 C86347

EDWARDSIELLA EDWARDSIELLA HOSHINAE EDWARDSIELLA ICTALURI EDWARDSIELLA TARDA

Edwardsiella Edwardsiella hoshinae Edwardsiella ictaluri Edwardsiella tarda

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 279 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86348 C86349 C86350 C86351 C86352 C86353

CDISC Submission Value EGGERTHELLA EGGERTHELLA LENTA EIKENELLA EIKENELLA CORRODENS ELIZABETHKINGIA ELIZABETHKINGIA MENINGOCEPTICA

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Eggerthella genus level.

NCI Preferred Term Eggerthella Eggerthella lenta Eikenella Eikenella corrodens Elizabethkingia Elizabethkingia meningoceptica

EUBACTERIUM Any bacterial organism that can be assigned to the LENTUM species Eggerthella lenta. Any bacteria that is not assigned to the species level but can be assigned to the Eikenella genus level. CDC GROUP HB-1 Any bacterial organism that can be assigned to the species Eikenella corrodens. Any bacteria that is not assigned to the species level but can be assigned to the Elizabethkingia genus level. CHRYSEOBACT Any bacterial organism that can be assigned to the ERIUM species Elizabethkingia meningoceptica. MENINGOSEPT ICUM; FLAVOBACTER IUM MENINGOSEPT ICUM Any bacteria that is not assigned to the species level but can be assigned to the Empedobacter genus level. FLAVOBACTER Any bacterial organism that can be assigned to the IUM BREVE species Empedobacter brevis. Any bacteria that is not assigned to the species level but can be assigned to the Enterobacter genus level. AEROBACTER AEROGENES Any bacterial organism that can be assigned to the species Enterobacter aerogenes.

C86354 C86355 C76310 C86356 C86357

EMPEDOBACTER EMPEDOBACTER BREVIS ENTEROBACTER ENTEROBACTER AEROGENES ENTEROBACTER AMNIGENUS ENTEROBACTER ASBURIAE ENTEROBACTER CANCEROGENUS

Empedobacter Empedobacter brevis Enterobacter Enterobacter aerogenes Enterobacter amnigenus

ENTEROBACTE Any bacterial organism that can be assigned to the R AMNIGENUS species Enterobacter amnigenus. I CDC ENTERIC GROUP 17 Any bacterial organism that can be assigned to the species Enterobacter asburiae.

C86358 C86359

Enterobacter asburiae Enterobacter cancerogenus

CDC ENTERIC Any bacterial organism that can be assigned to the GROUP 19; species Enterobacter cancerogenus. ENTEROBACTE R TAYLORAE

C86360

ENTEROBACTER CLOACAE ENTEROBACTE Any bacterial organism that can be assigned to the R CLOACAE species Enterobacter cloacae. STRAIN 1 ENTEROBACTER GERGOVIAE ENTEROBACTER HORMAECHEI ENTEROBACTER TAYLORAE ENTEROCOCCUS PRESUMPTIVE ENTEROCOCC US CDC ENTERIC GROUP 75 Any bacterial organism that can be assigned to the species Enterobacter gergoviae. Any bacterial organism that can be assigned to the species Enterobacter hormaechei. Any bacterial organism that can be assigned to the species Enterobacter taylorae. Any bacteria that is not assigned to the species level but can be assigned to the Enterococcus genus level.

Enterobacter cloacae

C86361 C86362 C86363 C76311

Enterobacter gergoviae Enterobacter hormaechei Enterobacter taylorae Enterococcus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 280 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym STREPTOCOCC US AVIUM

NCI Code C86364 C86365 C86366 C86367 C86368 C86369 C86370 C86371 C86372 C86373 C86374 C86375 C86376 C86377 C77208 C86378 C86379 C14206 C86881 C86882 C86883 C86884

CDISC Submission Value ENTEROCOCCUS AVIUM ENTEROCOCCUS CASSELIFLAVUS ENTEROCOCCUS DISPAR ENTEROCOCCUS DURANS ENTEROCOCCUS FAECALIS

CDISC Definition Any bacterial organism that can be assigned to the species Enterococcus avium. Any bacterial organism that can be assigned to the species Enterococcus casseliflavus. Any bacterial organism that can be assigned to the species Enterococcus dispar.

NCI Preferred Term Enterococcus avium Enterococcus casseliflavus Enterococcus dispar Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Enterococcus malodoratus Enterococcus mundtii Enterococcus pseudoavium Enterococcus raffinosus Erysipelothrix Erysipelothrix rhusiopathiae Escherichia Escherichia albertii Escherichia blattae Escherichia coli Escherichia coli strain O111 Escherichia coli strain O157 Escherichia coli strain O157:H7 Escherichia coli strain O26

STREPTOCOCC US DURANS STREPTOCOCC US FAECALIS

Any bacterial organism that can be assigned to the species Enterococcus durans. Any bacterial organism that can be assigned to the species Enterococcus faecalis. Any bacterial organism that can be assigned to the species Enterococcus faecium. Any bacterial organism that can be assigned to the species Enterococcus gallinarum. Any bacterial organism that can be assigned to the species Enterococcus hirae. Any bacterial organism that can be assigned to the species Enterococcus malodoratus. Any bacterial organism that can be assigned to the species Enterococcus mundtii. Any bacterial organism that can be assigned to the species Enterococcus pseudoavium. Any bacterial organism that can be assigned to the species Enterococcus raffinosus.

ENTEROCOCCUS FAECIUM STREPTOCOCC US FAECIUM ENTEROCOCCUS GALLINARUM ENTEROCOCCUS HIRAE ENTEROCOCCUS MALODORATUS ENTEROCOCCUS MUNDTII ENTEROCOCCUS PSEUDOAVIUM ENTEROCOCCUS RAFFINOSUS ERYSIPELOTHRIX ERYSIPELOTHRIX RHUSIOPATHIAE ESCHERICHIA ESCHERICHIA ALBERTII ESCHERICHIA BLATTAE ESCHERICHIA COLI ESCHERICHIA COLI O111 ESCHERICHIA COLI O157 (NOT H7) ESCHERICHIA COLI O157:H7 ESCHERICHIA COLI O26 E. COLI ERYSIPELOTH RIX INSIDIOSA

Any bacteria that is not assigned to the species level but can be assigned to the Erysipelothrix genus level. Any bacterial organism that can be assigned to the species Erysipelothrix rhusiopathiae. Any bacteria that is not assigned to the species level but can be assigned to the Escherichia genus level. Any bacterial organism that can be assigned to the species Escherichia albertii. Any bacterial organism that can be assigned to the species Escherichia blattae. Any bacterial organism that can be assigned to the species Escherichia coli. Any bacterial organism that can be assigned to the species Escherichia coli and strain O111. Any bacterial organism that can be assigned to the species Escherichia coli and strain O157. Any bacterial organism that can be assigned to the species Escherichia coli and strain O157:H7. Any bacterial organism that can be assigned to the species Escherichia coli and strain O26.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 281 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86380 C86381 C86382 C86383 C86384 C86385 C86386 C86387 C86388 C86389 C86390 C86391 C86885

CDISC Submission Value

CDISC Definition Any bacterial organism that can be assigned to the species Escherichia fergusonii. Any bacterial organism that can be assigned to the species Escherichia hermannii. Any bacterial organism that can be assigned to the species Escherichia vulneris. Any bacteria that is not assigned to the species level but can be assigned to the Eubacterium genus level. Any bacterial organism that can be assigned to the species Eubacterium adactolyticum. Any bacterial organism that can be assigned to the species Eubacterium contortum. Any bacterial organism that can be assigned to the species Eubacterium limosum. Any bacterial organism that can be assigned to the species Eubacterium nodatum. Any bacterial organism that can be assigned to the species Eubacterium rectale. Any bacterial organism that can be assigned to the species Eubacterium ventriosum. Any bacteria that is not assigned to the species level but can be assigned to the Ewingella genus level.

NCI Preferred Term Escherichia fergusonii Escherichia hermannii Escherichia vulneris Eubacterium Eubacterium adactolyticum Eubacterium contortum Eubacterium limosum Eubacterium nodatum Eubacterium rectale Eubacterium ventriosum Ewingella Ewingella americana Exiguobacterium

ESCHERICHIA FERGUSONII CDC ENTERIC GROUP 10 ESCHERICHIA HERMANNII CDC ENTERIC GROUP 11 ESCHERICHIA VULNERIS EUBACTERIUM EUBACTERIUM ALACTOLYTICUM EUBACTERIUM CONTORTUM EUBACTERIUM LIMOSUM EUBACTERIUM NODATUM EUBACTERIUM RECTALE EUBACTERIUM VENTRIOSUM EWINGELLA EWINGELLA AMERICANA EXIGUOBACTERIUM CDC ENTERIC GROUP 40 CDC ENTERIC GROUP 1

Any bacterial organism that can be assigned to the species Ewingella americana. Any bacteria that is not assigned to the species level but can be assigned to the Exiguobacterium genus level.

C86886

EXIGUOBACTERIUM ACETYLICUM FACKLAMIA FAECALIBACTERIUM

BREVIBACTERI Any bacterial organism that can be assigned to the UM species Exiguobacterium acetylicum. ACETYLICUM Any bacteria that is not assigned to the species level but can be assigned to the Facklamia genus level. Any bacteria that is not assigned to the species level but can be assigned to the Faecalibacterium genus level. FUSOBACTERI UM PRAUSNITZII FERMENTATIV E GRAM-NEGATI VE ROD Any bacterial organism that can be assigned to the species Faecalibacterium prausnitzii. Any rod-shaped, anaerobic bacteria that can convert carbohydrates into acids and alcohols and has a cell wall contains low levels of peptidoglycan and stains pink with the Gram staining technique. Any bacteria that is not assigned to the species level but can be assigned to the Finegoldia genus level.

Exiguobacterium acetylicum

C86392 C86393

Facklamia Faecalibacterium

C86394

FAECALIBACTERIUM PRAUSNITZII FERMENTATIVE GRAM-NEGATIVE BACILLUS FINEGOLDIA

Faecalibacterium prausnitzii

C86395

Fermentative Gram Negative Bacillus

C86887

Finegoldia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 282 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym PEPTOSTREPT OCOCCUS MAGNUS

NCI Code C86888

CDISC Submission Value FINEGOLDIA MAGNA

CDISC Definition Any bacterial organism that can be assigned to the species Finegoldia magna. Any bacteria that is not assigned to the species level but can be assigned to the Flavobacterium genus level. Any bacteria that is not assigned to the species level but can be assigned to the Francisella genus level.

NCI Preferred Term Finegoldia magna

C76320 C86396 C86397 C76323 C86398 C86399 C86400 C86401 C86404 C86405 C86406 C86407

FLAVOBACTERIUM FRANCISELLA FRANCISELLA TULARENSIS FUSOBACTERIUM FUSOBACTERIUM GONIDIAFORMANS FUSOBACTERIUM MORTIFERUM FUSOBACTERIUM NECROGENES FUSOBACTERIUM NECROPHORUM FUSOBACTERIUM NUCLEATUM FUSOBACTERIUM RUSSII FUSOBACTERIUM ULCERANS FUSOBACTERIUM VARIUM FUSOBACTERI UM PSEUDONECR OPHORUM; FUSOBACTERI UM NECROPHORU M BIOVAR C GARDNERELLA GARDNERELLA VAGINALIS GEMELLA GEMELLA BERGERI GEMELLA HAEMOLYSANS NEISSERIA HAEMOLYSAN S PASTEURELLA TULARENSIS

Flavobacterium Francisella Francisella tularensis Fusobacterium Fusobacterium gonidiaformans Fusobacterium mortiferum Fusobacterium necrogenes Fusobacterium necrophorum Fusobacterium nucleatum Fusobacterium russii Fusobacterium ulcerans Fusobacterium varium

Any bacterial organism that can be assigned to the species Francisella tularensis. Any bacteria that is not assigned to the species level but can be assigned to the Fusobacterium genus level. Any bacterial organism that can be assigned to the species Fusobacterium gonidiaformans. Any bacterial organism that can be assigned to the species Fusobacterium mortiferum. Any bacterial organism that can be assigned to the species Fusobacterium necrogenes. Any bacterial organism that can be assigned to the species Fusobacterium necrophorum. Any bacterial organism that can be assigned to the species Fusobacterium nucleatum. Any bacterial organism that can be assigned to the species Fusobacterium russii. Any bacterial organism that can be assigned to the species Fusobacterium ulcerans. Any bacterial organism that can be assigned to the species Fusobacterium varium.

C86409 C86410

Any bacteria that is not assigned to the species level but can be assigned to the Gardnerella genus level. CORYNEBACTE Any bacterial organism that can be assigned to the RIUM species Gardnerella vaginalis. VAGINALIS Any bacteria that is not assigned to the species level but can be assigned to the Gemella genus level. Any bacterial organism that can be assigned to the species Gemella bergeri. Any bacterial organism that can be assigned to the species Gemella haemolysans.

Gardnerella Gardnerella vaginalis

C86889 C86890 C86891

Gemella Gemella bergeri Gemella haemolysans

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 283 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym STREPTOCOCC US MORBILLORU M

NCI Code C86892

CDISC Submission Value GEMELLA MORBILLORUM

CDISC Definition Any bacterial organism that can be assigned to the species Gemella morbillorum.

NCI Preferred Term Gemella morbillorum

C86893 C86411 C86412 C86413 C86414 C86415

GEMELLA SANGUINIS GLOBICATELLA GLOBICATELLA SANGUINIS GLOBICATELLA SULFIDIFACIENS GORDONIA GORDONIA AICHIENSIS GLOBICATELL A SANGUIS

Any bacterial organism that can be assigned to the species Gemella sanguinis. Any bacteria that is not assigned to the species level but can be assigned to the Globicatella genus level. Any bacterial organism that can be assigned to the species Globicatella sanguinis. Any bacterial organism that can be assigned to the species Globicatella sulfidifaciens. Any bacteria that is not assigned to the species level but can be assigned to the Gordonia genus level. TSUKAMUREL Any bacterial organism that can be assigned to the LA AICHIENSIS; species Gordonia aichiensis. GORDONA AICHIENSIS RHODOCOCCU S BRONCHIALIS; GORDONA BRONCHIALIS Any bacterial organism that can be assigned to the species Gordonia bronchialis.

Gemella sanguinis Globicatella Globicatella sanguinis Globicatella sulfidifaciens Gordonia Gordonia aichiensis

C86416

GORDONIA BRONCHIALIS

Gordonia bronchialis

C86417

GORDONIA RUBRIPERTINCTA

RHODOCOCCU Any bacterial organism that can be assigned to the S species Gordonia rubripertincta. RUBRIPERTINC TA; GORDONA RUBROPERTIN CTA GORDONA SPUTI RHODOCOCCU S TERRAE; GORDONA TERRAE Any bacterial organism that can be assigned to the species Gordonia sputi. Any bacterial organism that can be assigned to the species Gordonia terrae.

Gordonia rubripertincta

C86418 C86419

GORDONIA SPUTI GORDONIA TERRAE

Gordonia sputi Gordonia terrae

C86420 C86421

GRACILIBACILLUS GRAM-NEGATIVE BACILLUS GRAM-NEGATIVE COCCUS

Any bacteria that is not assigned to the species level but can be assigned to the Gracilibacillus genus level. Any rod-shaped bacteria that contains low levels of peptidoglycan in its cell wall and stains pink with the Gram staining technique. Any spherical-shaped bacteria that contains low levels of peptidoglycan in its cell wall and stains pink with the Gram staining technique. Any rod-shaped bacteria that has a peptidoglycan-rich cell wall that stains dark purple with the Gram staining technique. Any spherical-shaped bacteria that has a peptidoglycan-rich cell wall that stains dark purple with the Gram staining technique.

Gracilibacillus Gram Negative Bacillus

C86422

Gram Negative Coccus

C62589

GRAM-POSITIVE BACILLUS

Gram-Positive Rod

C86424

GRAM-POSITIVE COCCUS

Gram Positive Coccus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 284 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86425 C86426

CDISC Submission Value GRANULICATELLA GRANULICATELLA ADIACENS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Granulicatella genus level.

NCI Preferred Term Granulicatella Granulicatella adiacens

ABIOTROPHIA ADJACENS; STREPTOCOCC US ADJACENS VIBRIO HOLLISAE

Any bacterial organism that can be assigned to the species Granulicatella adiacens.

C86427 C76324 C86428 C86429 C86430 C86431 C86432 C86433

GRIMONTIA HOLLISAE HAEMOPHILUS HAEMOPHILUS AEGYPTIUS HAEMOPHILUS HAEMOGLOBINOPHILUS HAEMOPHILUS HAEMOLYTICUS HAEMOPHILUS INFLUENZAE HAEMOPHILUS PARAHAEMOLYTICUS HAEMOPHILUS PARAINFLUENZAE HAFNIA HAFNIA ALVEI HALOBACILLUS HELCOCOCCUS HELCOCOCCUS KUNZII HELCOCOCCUS PYOGENES HELCOCOCCUS SUECIENSIS HELICOBACTER HELICOBACTER CINAEDI HELICOBACTER FELIS

Any bacterial organism that can be assigned to the species Grimontia hollisae. Any bacteria that is not assigned to the species level but can be assigned to the Haemophilus genus level. Any bacterial organism that can be assigned to the species Haemophilus aegyptius. Any bacterial organism that can be assigned to the species Haemophilus haemoglobinophilus. Any bacterial organism that can be assigned to the species Haemophilus haemolyticus.

Grimontia hollisae Haemophilus Haemophilus aegyptius Haemophilus haemoglobinophilus Haemophilus haemolyticus Haemophilus influenzae Haemophilus parahaemolyticus Haemophilus parainfluenzae

H-FLU

Any bacterial organism that can be assigned to the species Haemophilus influenzae. Any bacterial organism that can be assigned to the species Haemophilus parahaemolyticus.

HEMOPHILUS PARAINFLUEN ZAE

Any bacterial organism that can be assigned to the species Haemophilus parainfluenzae. Any bacteria that is not assigned to the species level but can be assigned to the Hafnia genus level.

C86434 C86435 C86436 C86873 C86878 C86879 C86880 C14296 C86437 C14330

Hafnia Hafnia alvei Halobacillus Helcococcus Helcococcus kunzii Helcococcus pyogenes Helcococcus sueciensis Helicobacter Helicobacter cinaedi Helicobacter felis

ENTEROBACTE Any bacterial organism that can be assigned to the R ALVEI species Hafnia alvei. Any bacteria that is not assigned to the species level but can be assigned to the Halobacillus genus level. Any bacteria that is not assigned to the species level but can be assigned to the Helcococcus genus level. Any bacterial organism that can be assigned to the species Helcococcus kunzii. Any bacterial organism that can be assigned to the species Helcococcus pyogenes. Any bacterial organism that can be assigned to the species Helcococcus sueciensis. Any bacteria that is not assigned to the species level but can be assigned to the Helicobacter genus level. CAMPYLOBAC TER CINAEDI H. FELIS Any bacterial organism that can be assigned to the species Helicobacter cinaedi. Any bacterial organism that can be assigned to the species Helicobacter felis.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 285 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym CAMPYLOBAC TER FENNELLIAE CAMPYLOBAC TER MUSTELAE H. PYLORI; CAMPYLOBAC TER PYLORI FLEXISPIRA RAPPINI

NCI Code C86438

CDISC Submission Value HELICOBACTER FENNELLIAE HELICOBACTER MUSTELAE HELICOBACTER PYLORI

CDISC Definition Any bacterial organism that can be assigned to the species Helicobacter fennelliae. Any bacterial organism that can be assigned to the species Helicobacter mustelae. Any bacterial organism that can be assigned to the species Helicobacter pylori. Any bacterial organism that can be assigned to the species Helicobacter rappini.

NCI Preferred Term Helicobacter fennelliae

C86439

Helicobacter mustelae

C14289

Helicobacter pylori

C86440 C86441 C86442 C86443 C86444 C86445 C86446 C86447 C86448 C86449 C86450 C86451 C86452 C86453 C28165 C86454 C86455

HELICOBACTER RAPPINI HISTOPHILUS SOMNI HOLDEMANIA HOLDEMANIA FILIFORMIS INQUILINUS INQUILINUS LIMOSUS JEOTGALIBACILLUS JOHNSONELLA JOHNSONELLA IGNAVA KINGELLA

Helicobacter rappini Histophilus somni Holdemania Holdemania filiformis Inquilinus Inquilinus limosus Jeotgalibacillus Johnsonella Johnsonella ignava Kingella Kingella denitrificans Kingella kingae Kingella oralis Kingella potus Klebsiella Klebsiella granulomatis Klebsiella oxytoca

HAEMOPHILUS Any bacterial organism that can be assigned to the SOMNUS species Histophilus somni. Any bacteria that is not assigned to the species level but can be assigned to the Holdemania genus level. Any bacterial organism that can be assigned to the species Holdemania filiformis. Any bacteria that is not assigned to the species level but can be assigned to the Inquilinus genus level. Any bacterial organism that can be assigned to the species Inquilinus limosus. Any bacteria that is not assigned to the species level but can be assigned to the Jeotgalibacillus genus level. Any bacteria that is not assigned to the species level but can be assigned to the Johnsonella genus level. Any bacterial organism that can be assigned to the species Johnsonella ignava. Any bacteria that is not assigned to the species level but can be assigned to the Kingella genus level. Any bacterial organism that can be assigned to the species Kingella denitrificans. Any bacterial organism that can be assigned to the species Kingella kingae. Any bacterial organism that can be assigned to the species Kingella oralis. Any bacterial organism that can be assigned to the species Kingella potus. Any bacteria that is not assigned to the species level but can be assigned to the Klebsiella genus level. Any bacterial organism that can be assigned to the species Klebsiella granulomatis. K. OXYTOCA Any bacterial organism that can be assigned to the species Klebsiella oxytoca.

KINGELLA DENITRIFICANS CDC GROUP TM-1 KINGELLA KINGAE KINGELLA ORALIS KINGELLA POTUS KLEBSIELLA KLEBSIELLA GRANULOMATIS KLEBSIELLA OXYTOCA MORAXELLA KINGAE

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 286 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym KLEBSIELLA PNEUMONIAE SUBSP. OZAENAE K. PNEUMONIAE KLEBSIELLA PNEUMONIAE SUBSP. RHINOSCLERO MATIS

NCI Code C86456

CDISC Submission Value KLEBSIELLA OZAENAE

CDISC Definition Any bacterial organism that can be assigned to the species Klebsiella ozaenae.

NCI Preferred Term Klebsiella ozaenae

C86457 C86458

KLEBSIELLA PNEUMONIAE KLEBSIELLA RHINOSCLEROMATIS

Any bacterial organism that can be assigned to the species Klebsiella pneumoniae. Any bacterial organism that can be assigned to the species Klebsiella rhinoscleromatis.

Klebsiella pneumoniae Klebsiella rhinoscleromatis

C86459 C86460 C86461 C86462 C86463 C86464 C86465

KLEBSIELLA SINGAPORENSIS KLEBSIELLA VARIICOLA KLUYVERA KLUYVERA ASCORBATA KLUYVERA CRYOCRESCENS KLUYVERA GEORGIANA KLUYVERA INTERMEDIA CDC ENTERIC GROUP 8

Any bacterial organism that can be assigned to the species Klebsiella singaporensis. Any bacterial organism that can be assigned to the species Klebsiella variicola. Any bacteria that is not assigned to the species level but can be assigned to the Kluyvera genus level. Any bacterial organism that can be assigned to the species Kluyvera ascorbata. Any bacterial organism that can be assigned to the species Kluyvera cryocrescens. Any bacterial organism that can be assigned to the species Kluyvera georgiana. ENTEROBACTE Any bacterial organism that can be assigned to the R species Kluyvera intermedia. INTERMEDIUM ; ENTEROBACTE R INTERMEDIUS; KLUYVERA COCHLEAE Any bacteria that is not assigned to the species level but can be assigned to the Knoellia genus level. Any bacteria that is not assigned to the species level but can be assigned to the Kocuria genus level. MICROCOCCU S KRISTINAE Any bacterial organism that can be assigned to the species Kocuria kristinae. Any bacterial organism that can be assigned to the species Kocuria rosea. Any bacterial organism that can be assigned to the species Kocuria varians. Any bacteria that is not assigned to the species level but can be assigned to the Kurthia genus level. Any bacteria that is not assigned to the species level but can be assigned to the Kytococcus genus level. Any bacterial organism that can be assigned to the species Kytococcus sedentarius.

Klebsiella singaporensis Klebsiella variicola Kluyvera Kluyvera ascorbata Kluyvera cryocrescens Kluyvera georgiana Kluyvera intermedia

C86466 C86467 C86468 C86469 C86470 C86471 C86472 C86473

KNOELLIA KOCURIA KOCURIA KRISTINAE KOCURIA ROSEA KOCURIA VARIANS KURTHIA KYTOCOCCUS KYTOCOCCUS SEDENTARIUS

Knoellia Kocuria Kocuria kristinae Kocuria rosea Kocuria varians Kurthia Kytococcus Kytococcus sedentarius

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 287 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C76352 C86474 C86475 C86476 C86477

CDISC Submission Value LACTOBACILLUS LACTOBACILLUS ACIDOPHILUS LACTOBACILLUS BREVIS LACTOBACILLUS CASEI LACTOBACILLUS CATENAFORMIS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Lactobacillus genus level. Any bacterial organism that can be assigned to the species Lactobacillus acidophilus. Any bacterial organism that can be assigned to the species Lactobacillus brevis. Any bacterial organism that can be assigned to the species Lactobacillus casei.

NCI Preferred Term Lactobacillus Lactobacillus acidophilus Lactobacillus brevis Lactobacillus casei Lactobacillus catenaformis

LACTOBACILL US CATENAFORM E

Any bacterial organism that can be assigned to the species Lactobacillus catenaformis.

C86478 C86479 C86480 C86481 C86482 C86483 C86484 C86485 C86486 C86487 C76353 C86488 C86489 C86490 C86491

LACTOBACILLUS FERMENTUM LACTOBACILLUS GALLINARUM LACTOBACILLUS JENSENII LACTOBACILLUS JOHNSONII LACTOBACILLUS SALIVARIUS LACTOCOCCUS LACTOCOCCUS GARVIEAE LACTOCOCCUS LACTIS LECLERCIA LECLERCIA ADECARBOXYLATA LEGIONELLA LEGIONELLA LONGBEACHAE LEGIONELLA PNEUMOPHILA LEIFSONIA LEIFSONIA AQUATICA CDC ENTERIC GROUP 41 DOEDERLEIN BACILLUS

Any bacterial organism that can be assigned to the species Lactobacillus fermentum. Any bacterial organism that can be assigned to the species Lactobacillus gallinarum. Any bacterial organism that can be assigned to the species Lactobacillus jensenii. Any bacterial organism that can be assigned to the species Lactobacillus johnsonii. Any bacterial organism that can be assigned to the species Lactobacillus salivarius. Any bacteria that is not assigned to the species level but can be assigned to the Lactococcus genus level. Any bacterial organism that can be assigned to the species Lactococcus garvieae. Any bacterial organism that can be assigned to the species Lactococcus lactis. Any bacteria that is not assigned to the species level but can be assigned to the Leclercia genus level. Any bacterial organism that can be assigned to the species Leclercia adecarboxylata. Any bacteria that is not assigned to the species level but can be assigned to the Legionella genus level. Any bacterial organism that can be assigned to the species Legionella longbeachae. Any bacterial organism that can be assigned to the species Legionella pneumophila. Any bacteria that is not assigned to the species level but can be assigned to the Leifsonia genus level. CORYNEBACTE Any bacterial organism that can be assigned to the RIUM species Leifsonia aquatica. AQUATICUM Any bacteria that is not assigned to the species level but can be assigned to the Leminorella genus level.

Lactobacillus fermentum Lactobacillus gallinarum Lactobacillus jensenii Lactobacillus johnsonii Lactobacillus salivarius Lactococcus Lactococcus garvieae Lactococcus lactis Leclercia Leclercia adecarboxylata Legionella Legionella longbeachae Legionella pneumophila Leifsonia Leifsonia aquatica

C86492

LEMINORELLA

Leminorella

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 288 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86493 C86494 C76355 C76357 C86495 C86496 C86497 C86498 C76359 C86499 C86500 C86501

CDISC Submission Value

CDISC Definition Any bacterial organism that can be assigned to the species Leminorella grimontii. Any bacterial organism that can be assigned to the species Leminorella richardii. Any bacteria that is not assigned to the species level but can be assigned to the Leptospira genus level. Any bacteria that is not assigned to the species level but can be assigned to the Leuconostoc genus level. Any bacterial organism that can be assigned to the species Leuconostoc citreum. Any bacterial organism that can be assigned to the species Leuconostoc lactis. Any bacterial organism that can be assigned to the species Leuconostoc mesenteroides. Any bacterial organism that can be assigned to the species Leuconostoc pseudomesenteroides. Any bacteria that is not assigned to the species level but can be assigned to the Listeria genus level. Any bacterial organism that can be assigned to the species Listeria grayi. Any bacterial organism that can be assigned to the species Listeria innocua.

NCI Preferred Term Leminorella grimontii Leminorella richardii Leptospira Leuconostoc Leuconostoc citreum Leuconostoc lactis Leuconostoc mesenteroides Leuconostoc pseudomesenteroides Listeria Listeria grayi Listeria innocua Listeria ivanovii

LEMINORELLA GRIMONTII CDC ENTERIC GROUP 57 LEMINORELLA RICHARDII LEPTOSPIRA LEUCONOSTOC LEUCONOSTOC CITREUM LEUCONOSTOC LACTIS LEUCONOSTOC MESENTEROIDES LEUCONOSTOC PSEUDOMESENTEROIDES LISTERIA LISTERIA GRAYI LISTERIA INNOCUA LISTERIA IVANOVII LISTERIA MONOCYTOGE NES SEROVAR 5

Any bacterial organism that can be assigned to the species Listeria ivanovii.

C86502 C86503 C86504 C86505 C86506

LISTERIA MONOCYTOGENES LISTERIA SEELIGERI LISTERIA WELSHIMERI MACROCOCCUS MACROCOCCUS CASEOLYTICUS

Any bacterial organism that can be assigned to the species Listeria monocytogenes. Any bacterial organism that can be assigned to the species Listeria seeligeri. Any bacterial organism that can be assigned to the species Listeria welshimeri. Any bacteria that is not assigned to the species level but can be assigned to the Macrococcus genus level. STAPHYLOCOC Any bacterial organism that can be assigned to the CUS species Macrococcus caseolyticus. CASEOLYTICU S Any bacteria that is not assigned to the species level but can be assigned to the Mannheimia genus level. PASTEURELLA Any bacterial organism that can be assigned to the HAEMOLYTICA species Mannheimia haemolytica. Any bacteria that is not assigned to the species level but can be assigned to the Megasphaera genus level.

Listeria monocytogenes Listeria seeligeri Listeria welshimeri Macrococcus Macrococcus caseolyticus

C86507 C86508 C86895

MANNHEIMIA MANNHEIMIA HAEMOLYTICA MEGASPHAERA

Mannheimia Mannheimia haemolytica Megasphaera

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 289 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym PEPTOSTREPT OCOCCUS ELSDENII

NCI Code C86896

CDISC Submission Value MEGASPHAERA ELSDENII

CDISC Definition Any bacterial organism that can be assigned to the species Megasphaera elsdenii. Any bacteria that is not assigned to the species level but can be assigned to the Methylobacterium genus level.

NCI Preferred Term Megasphaera elsdenii

C76361

METHYLOBACTERIUM

Methylobacterium

C86510

METHYLOBACTERIUM MESOPHILICUM MICROBACTERIUM

PSEUDOMONA S MESOPHILICA CDC CORYNEFORM GROUP A-4, A-5

Any bacterial organism that can be assigned to the species Methylobacterium mesophilicum. Any bacteria that is not assigned to the species level but can be assigned to the Microbacterium genus level.

Methylobacterium mesophilicum

C85511

Microbacterium

C86512 C77086 C86513 C86514 C86515 C86516 C86517 C86518 C86519 C86520 C86521 C86898 C86899 C86009 C86523 C86524

MICROBACTERIUM PARAOXYDANS MICROCOCCUS MICROCOCCUS LUTEUS MICROCOCCUS LYLAE MITSUOKELLA MITSUOKELLA MULTACIDA MOBILUNCUS MOBILUNCUS CURTISII MOBILUNCUS MULIERIS MOELLERELLA MOELLERELLA WISCONSENSIS MOGIBACTERIUM MOGIBACTERIUM TIMIDUM MORAXELLA MORAXELLA ATLANTAE MORAXELLA BOVIS CDC ENTERIC GROUP 46 SARCINA LUTEA

Any bacterial organism that can be assigned to the species Microbacterium paraoxydans. Any bacteria that is not assigned to the species level but can be assigned to the Micrococcus genus level. Any bacterial organism that can be assigned to the species Micrococcus luteus. Any bacterial organism that can be assigned to the species Micrococcus lylae. Any bacteria that is not assigned to the species level but can be assigned to the Mitsuokella genus level. Any bacterial organism that can be assigned to the species Mitsuokella multacida. Any bacteria that is not assigned to the species level but can be assigned to the Mobiluncus genus level. Any bacterial organism that can be assigned to the species Mobiluncus curtisii. Any bacterial organism that can be assigned to the species Mobiluncus mulieris. Any bacteria that is not assigned to the species level but can be assigned to the Moellerella genus level. Any bacterial organism that can be assigned to the species Moellerella wisconsensis. Any bacteria that is not assigned to the species level but can be assigned to the Mogibacterium genus level. EUBACTERIUM Any bacterial organism that can be assigned to the TIMIDUM species Mogibacterium timidum. BRANHAMELL A SPECIES CDC GROUP M-3 Any bacteria that is not assigned to the species level but can be assigned to the Moraxella genus level. Any bacterial organism that can be assigned to the species Moraxella atlantae. Any bacterial organism that can be assigned to the species Moraxella bovis.

Microbacterium paraoxydans Micrococcus Micrococcus luteus Micrococcus lylae Mitsuokella Mitsuokella multacida Mobiluncus Mobiluncus curtisii Mobiluncus mulieris Moellerella Moellerella wisconsensis Mogibacterium Mogibacterium timidum Moraxella Moraxella atlantae Moraxella bovis

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 290 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86525 C76210

CDISC Submission Value MORAXELLA CANIS MORAXELLA CATARRHALIS MORAXELLA LACUNATA MORAXELLA LINCOLNII MORAXELLA NONLIQUEFACIENS MORAXELLA OBLONGA MORAXELLA OSLOENSIS MORGANELLA MORGANELLA MORGANII MYCOBACTERIUM MYCOBACTERIUM ABSCESSUS

CDISC Definition Any bacterial organism that can be assigned to the species Moraxella canis.

NCI Preferred Term Moraxella canis Moraxella catarrhalis

BRANHAMELL A CATARRHALIS

Any bacterial organism that can be assigned to the species Moraxella catarrhalis.

C86526 C86527 C86528 C86529 C86530 C86531 C86015 C76369 C86533

MORAXELLA Any bacterial organism that can be assigned to the LIQUEFACIENS species Moraxella lacunata. Any bacterial organism that can be assigned to the species Moraxella lincolnii. Any bacterial organism that can be assigned to the species Moraxella nonliquefaciens. Any bacterial organism that can be assigned to the species Moraxella oblonga. Any bacterial organism that can be assigned to the species Moraxella osloensis. Any bacteria that is not assigned to the species level but can be assigned to the Morganella genus level. PROTEUS MORGANII Any bacterial organism that can be assigned to the species Morganella morganii. Any bacteria that is not assigned to the species level but can be assigned to the Mycobacterium genus level. MYCOBACTERI Any bacterial organism that can be assigned to the UM CHELONAE species Mycobacterium abscessus. SUBSP. ABSCESSUS Any bacterial organism that can be assigned to the species Mycobacterium africanum. Any bacterial organism that can be assigned to the species Mycobacterium avium. A non-taxonomic grouping of bacteria assigned to and including at least three related subspecies from the Mycobacterium avium species. MYCOBACTERI Any bacterial organism that can be assigned to the UM CHELONAE species Mycobacterium chelonae. SUBSP. CHELONAE Any bacterial organism that can be assigned to the species Mycobacterium flavescens. Any bacterial organism that can be assigned to the species Mycobacterium fortuitum. A non-taxonomic grouping of bacteria assigned to and including related species from the Mycobacterium genus. Any bacterial organism that can be assigned to the species Mycobacterium gastri.

Moraxella lacunata Moraxella lincolnii Moraxella nonliquefaciens Moraxella oblonga Moraxella osloensis Morganella Morganella morganii Mycobacterium Mycobacterium abscessus

C85544 C86535 C76368

MYCOBACTERIUM AFRICANUM MYCOBACTERIUM AVIUM MYCOBACTERIUM AVIUM COMPLEX MYCOBACTERIUM CHELONAE

Mycobacterium africanum Mycobacterium avium Mycobacterium avium complex

C86536

Mycobacterium chelonae

C86537 C86538 C86539

MYCOBACTERIUM FLAVESCENS MYCOBACTERIUM FORTUITUM MYCOBACTERIUM FORTUITUM COMPLEX MYCOBACTERIUM GASTRI

Mycobacterium flavescens Mycobacterium fortuitum Mycobacterium fortuitum Complex

C86540

Mycobacterium gastri

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 291 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86541 C86542 C91843 C85543 C86544 C86545 C86546 C86547 C86548 C86590 C86591 C86592 C86593 C76370 C86594

CDISC Submission Value MYCOBACTERIUM GORDONAE MYCOBACTERIUM HAEMOPHILUM MYCOBACTERIUM INTRACELLULARE MYCOBACTERIUM KANSASII MYCOBACTERIUM LEPRAE MYCOBACTERIUM MARINUM MYCOBACTERIUM PEREGRINUM MYCOBACTERIUM SCROFULACEUM

CDISC Definition

NCI Preferred Term Mycobacterium gordonae Mycobacterium haemophilum Mycobacterium intracellulare Mycobacterium kansasii Mycobacterium leprae Mycobacterium marinum Mycobacterium peregrinum Mycobacterium scrofulaceum Mycobacterium simiae Mycobacterium smegmatis Mycobacterium szulgai Mycobacterium terrae Mycobacterium thermoresistibile Mycobacterium tuberculosis Mycobacterium tuberculosis Complex Mycobacterium ulcerans Mycoplasma Mycoplasma hominis Mycoplasma orale Mycoplasma pneumoniae Myroides

MYCOBACTERI Any bacterial organism that can be assigned to the UM AQUAE species Mycobacterium gordonae. Any bacterial organism that can be assigned to the species Mycobacterium haemophilum. Any bacterial organism that can be assigned to the species Mycobacterium intracellulare. Any bacterial organism that can be assigned to the species Mycobacterium kansasii. Any bacterial organism that can be assigned to the species Mycobacterium leprae. MYCOBACTERI Any bacterial organism that can be assigned to the UM BALNEI species Mycobacterium marinum. Any bacterial organism that can be assigned to the species Mycobacterium peregrinum. Any bacterial organism that can be assigned to the species Mycobacterium scrofulaceum.

MYCOBACTERIUM SIMIAE MYCOBACTERI Any bacterial organism that can be assigned to the UM HABANA species Mycobacterium simiae. MYCOBACTERIUM SMEGMATIS MYCOBACTERIUM SZULGAI MYCOBACTERIUM TERRAE MYCOBACTERIUM THERMORESISTIBILE MYCOBACTERIUM TUBERCULOSIS MYCOBACTERIUM TUBERCULOSIS COMPLEX MYCOBACTERIUM ULCERANS MYCOPLASMA MYCOPLASMA HOMINIS MYCOPLASMA ORALE MYCOPLASMA PNEUMONIAE MYROIDES Any bacterial organism that can be assigned to the species Mycobacterium smegmatis. Any bacterial organism that can be assigned to the species Mycobacterium szulgai. Any bacterial organism that can be assigned to the species Mycobacterium terrae. Any bacterial organism that can be assigned to the species Mycobacterium thermoresistibile. Any bacterial organism that can be assigned to the species Mycobacterium tuberculosis. A non-taxonomic grouping of bacteria assigned to and including related species from the Mycobacterium genus. MYCOBACTERI Any bacterial organism that can be assigned to the UM BURULI species Mycobacterium ulcerans. Any bacteria that is not assigned to the species level but can be assigned to the Mycoplasma genus level. Any bacterial organism that can be assigned to the species Mycoplasma hominis. Any bacterial organism that can be assigned to the species Mycoplasma orale. Any bacterial organism that can be assigned to the species Mycoplasma pneumoniae. Any bacteria that is not assigned to the species level but can be assigned to the Myroides genus level.

C86595 C73540 C86597 C86598 C86599 C86953

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 292 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86954

CDISC Submission Value MYROIDES ODORATUS

CDISC Definition

NCI Preferred Term Myroides odoratus

FLAVOBACTER Any bacterial organism that can be assigned to the IUM species Myroides odoratus. ODORATUM Any bacteria that is not assigned to the species level but can be assigned to the Neisseria genus level. Any bacterial organism that can be assigned to the species Neisseria canis. MICROCOCCU S CINEREUS Any bacterial organism that can be assigned to the species Neisseria cinerea. Any bacterial organism that can be assigned to the species Neisseria flavescens. Any bacterial organism that can be assigned to the species Neisseria gonorrhoeae. Any bacterial organism that can be assigned to the species Neisseria lactamica. BETA-LACTAM Any bacterial organism that can be assigned to the ASE NEGATIVE species Neisseria meningitidis. NEISSERIA MENINGITIDIS Any bacterial organism that can be assigned to the species Neisseria mucosa. Any bacterial organism that can be assigned to the species Neisseria polysaccharea. Any bacterial organism that can be assigned to the species Neisseria sicca. Any bacterial organism that can be assigned to the species Neisseria subflava. CDC GROUP M-5 Any bacterial organism that can be assigned to the species Neisseria weaverii. Any bacteria that is not assigned to the species level but can be assigned to the Nocardia genus level. Any bacterial organism that can be assigned to the species Nocardia asteroides. A non-taxonomic grouping of bacteria assigned to and including at least four related species from the Nocardia genus. Any bacterial organism that can be assigned to the species Nocardia brasiliensis. Any bacterial organism that can be assigned to the species Nocardia dassonvillei. Any bacterial organism that can be assigned to the species Nocardia farcinica. Any bacterial organism that can be assigned to the species Nocardia nova.

C76371 C86600 C86601 C86602 C86603 C86604 C86605

NEISSERIA NEISSERIA CANIS NEISSERIA CINEREA NEISSERIA FLAVESCENS NEISSERIA GONORRHOEAE NEISSERIA LACTAMICA NEISSERIA MENINGITIDIS

Neisseria Neisseria canis Neisseria cinerea Neisseria flavescens Neisseria gonorrhoeae Neisseria lactamica Neisseria meningitidis

C86606 C86607 C86608 C86609 C86610 C76372 C86611 C86612

NEISSERIA MUCOSA NEISSERIA POLYSACCHAREA NEISSERIA SICCA NEISSERIA SUBFLAVA NEISSERIA WEAVERII NOCARDIA NOCARDIA ASTEROIDES NOCARDIA ASTEROIDES COMPLEX NOCARDIA BRASILIENSIS NOCARDIA DASSONVILLEI NOCARDIA FARCINICA NOCARDIA NOVA

Neisseria mucosa Neisseria polysaccharea Neisseria sicca Neisseria subflava Neisseria weaverii Nocardia Nocardia asteroides Nocardia asteroides Complex

C86613 C86614 C86615 C86616

Nocardia brasiliensis Nocardia dassonvillei Nocardia farcinica Nocardia nova

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 293 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym NOCARDIA CAVIAE NON-FERMENT ATIVE GRAM-NEGATI VE ROD

NCI Code C86617 C86618

CDISC Submission Value NOCARDIA OTITIDISCAVIARUM NON-FERMENTATIVE GRAM-NEGATIVE BACILLUS OCHROBACTRUM OCHROBACTRUM ANTHROPI OCHROBACTRUM INTERMEDIUM OERSKOVIA OERSKOVIA TURBATA OLIGELLA OLIGELLA UREOLYTICA OLIGELLA URETHRALIS OLSENELLA OLSENELLA ULI PANDORAEA PANDORAEA PNOMENUSA PANTOEA

CDISC Definition Any bacterial organism that can be assigned to the species Nocardia otitidiscaviarum. Any rod-shaped, anaerobic bacteria that cannot convert carbohydrates into acids and alcohols and has a cell wall that contains low levels of peptidoglycan and stains pink with the Gram staining technique. Any bacteria that is not assigned to the species level but can be assigned to the Ochrobactrum genus level.

NCI Preferred Term Nocardia otitidiscaviarum Non-Fermentative Gram Negative Bacillus

C86619 C86620

Ochrobactrum Ochrobactrum anthropi

ACHROMOBAC Any bacterial organism that can be assigned to the TER SUBSP. species Ochrobactrum anthropi. BIOTYPE 1 Any bacterial organism that can be assigned to the species Ochrobactrum intermedium. Any bacteria that is not assigned to the species level but can be assigned to the Oerskovia genus level. Any bacterial organism that can be assigned to the species Oerskovia turbata. Any bacteria that is not assigned to the species level but can be assigned to the Oligella genus level. CDC GROUP IVE CDC GROUP M-4 Any bacterial organism that can be assigned to the species Oligella ureolytica. Any bacterial organism that can be assigned to the species Oligella urethralis. Any bacteria that is not assigned to the species level but can be assigned to the Olsenella genus level. LACTOBACILL US ULI Any bacterial organism that can be assigned to the species Olsenella uli. Any bacteria that is not assigned to the species level but can be assigned to the Pandoraea genus level. Any bacterial organism that can be assigned to the species Pandoraea pnomenusa. Any bacteria that is not assigned to the species level but can be assigned to the Pantoea genus level.

C86621 C86622 C86623 C86624 C86625 C86626 C86627 C86628 C86629 C86630 C86631 C86632

Ochrobactrum intermedium Oerskovia Oerskovia turbata Oligella Oligella ureolytica Oligella urethralis Olsenella Olsenella uli Pandoraea Pandoraea pnomenusa Pantoea Pantoea agglomerans

PANTOEA AGGLOMERANS ENTEROBACTE Any bacterial organism that can be assigned to the R species Pantoea agglomerans. AGGLOMERAN S PARABACTEROIDES PARABACTEROIDES DISTASONIS PARABACTEROIDES MERDAE BACTEROIDES DISTASONIS BACTEROIDES MERDAE; BACTEROIDES FRAGILIS T4-1 Any bacteria that is not assigned to the species level but can be assigned to the Parabacteroides genus level. Any bacterial organism that can be assigned to the species Parabacteroides distasonis. Any bacterial organism that can be assigned to the species Parabacteroides merdae.

C86633 C86634 C86635

Parabacteroides Parabacteroides distasonis Parabacteroides merdae

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 294 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86900 C86901

CDISC Submission Value PARVIMONAS PARVIMONAS MICRA

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Parvimonas genus level.

NCI Preferred Term Parvimonas Parvimonas micra

PEPTOSTREPT OCOCCUS MICROS; MICROMONAS MICROS

Any bacterial organism that can be assigned to the species Parvimonas micra.

C86636 C86637 C86638 C86639

PASTEURELLA PASTEURELLA AEROGENES PASTEURELLA BETTYAE PASTEURELLA CANIS CDC GROUP HB-5 PASTEURELLA MULTOCIDA BIOTYPE 6 PASTEURELLA SEPTICA

Any bacteria that is not assigned to the species level but can be assigned to the Pasteurella genus level. Any bacterial organism that can be assigned to the species Pasteurella aerogenes. Any bacterial organism that can be assigned to the species Pasteurella bettyae. Any bacterial organism that can be assigned to the species Pasteurella canis. Any bacterial organism that can be assigned to the species Pasteurella multocida. Any bacterial organism that can be assigned to the species Pasteurella pneumotropica. Any bacteria that is not assigned to the species level but can be assigned to the Pediococcus genus level. Any bacteria that is not assigned to the species level but can be assigned to the Peptococcus genus level. MICROCOCCU S NIGER Any bacterial organism that can be assigned to the species Peptococcus niger. Any bacteria that is not assigned to the species level but can be assigned to the Peptoniphilus genus level. PEPTOCOCCUS ASACCHAROL YTICUS; PEPTOSTREPT OCOCCUS ASACCHAROL YTICUS PEPTOSTREPT OCOCCUS INDOLICUS Any bacterial organism that can be assigned to the species Peptoniphilus asaccharolyticus.

Pasteurella Pasteurella aerogenes Pasteurella bettyae Pasteurella canis

C76373 C86640 C86641 C86642 C86643 C86902 C86903

PASTEURELLA MULTOCIDA PASTEURELLA PNEUMOTROPICA PEDIOCOCCUS PEPTOCOCCUS PEPTOCOCCUS NIGER PEPTONIPHILUS PEPTONIPHILUS ASACCHAROLYTICUS

Pasteurella multocida Pasteurella pneumotropica Pediococcus Peptococcus Peptococcus niger Peptoniphilus Peptoniphilus asaccharolyticus

C86904

PEPTONIPHILUS INDOLICUS PEPTOSTREPTOCOCCUS

Any bacterial organism that can be assigned to the species Peptoniphilus indolicus. Any bacteria that is not assigned to the species level but can be assigned to the Peptostreptococcus genus level. Any bacterial organism that can be assigned to the species Peptostreptococcus anaerobius. Any bacteria that is not assigned to the species level but can be assigned to the Photobacterium genus level.

Peptoniphilus indolicus

C86644

Peptostreptococcus

C86645 C86646

PEPTOSTREPTOCOCCUS ANAEROBIUS PHOTOBACTERIUM

Peptostreptococcus anaerobius Photobacterium

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 295 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86647

CDISC Submission Value PHOTOBACTERIUM DAMSELAE

CDISC Definition

NCI Preferred Term Photobacterium damselae

VIBRIO Any bacterial organism that can be assigned to the DAMSELA; species Photobacterium damselae. CDC GROUP EF-5, PHOTOBACTER IUM DAMSELAE SUBSP. DAMSELAE Any bacteria that is not assigned to the species level but can be assigned to the Photorhabdus genus level. Any bacterial organism that can be assigned to the species Photorhabdus luminescens. Any bacteria that is not assigned to the species level but can be assigned to the Planococcus genus level. Any bacteria that is not assigned to the species level but can be assigned to the Plesiomonas genus level. AEROMONAS SHIGELLOIDES Any bacterial organism that can be assigned to the species Plesiomonas shigelloides. Any bacteria that is not assigned to the species level but can be assigned to the Porphyromonas genus level. BACTEROIDES ASACCHAROL YTICUS Any bacterial organism that can be assigned to the species Porphyromonas asaccharolytica. Any bacterial organism that can be assigned to the species Porphyromonas catoniae. BACTEROIDES Any bacterial organism that can be assigned to the ENDODONTALI species Porphyromonas endodontalis. S BACTEROIDES GINGIVALIS BACTEROIDES LEVII; BACTEROIDES MELANINOGE NICUS SUBSP. LEVII Any bacterial organism that can be assigned to the species Porphyromonas gingivalis. Any bacterial organism that can be assigned to the species Porphyromonas levii.

C86648 C86649 C86650 C86651 C86652 C86653 C86654

PHOTORHABDUS PHOTORHABDUS LUMINESCENS PLANOCOCCUS PLESIOMONAS PLESIOMONAS SHIGELLOIDES PORPHYROMONAS PORPHYROMONAS ASACCHAROLYTICA PORPHYROMONAS CATONIAE PORPHYROMONAS ENDODONTALIS PORPHYROMONAS GINGIVALIS PORPHYROMONAS LEVII

Photorhabdus Photorhabdus luminescens Planococcus Plesiomonas Plesiomonas shigelloides Porphyromonas Porphyromonas asaccharolytica

C86655 C86656

Porphyromonas catoniae Porphyromonas endodontalis

C86657 C86658

Porphyromonas gingivalis Porphyromonas levii

C86659 C86660 C86661

PORPHYROMONAS SOMERAE PREVOTELLA PREVOTELLA BIVIA BACTEROIDES BIVIA

Any bacterial organism that can be assigned to the species Porphyromonas somerae. Any bacteria that is not assigned to the species level but can be assigned to the Prevotella genus level. Any bacterial organism that can be assigned to the species Prevotella bivia.

Porphyromonas somerae Prevotella Prevotella bivia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 296 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym BACTEROIDES RUMINICOLA SUBSP. BREVUS; BACTEROIDES RUMINICOLA SUBSP. BREVIS BACTEROIDES BUCCAE

NCI Code C86662

CDISC Submission Value PREVOTELLA BREVIS

CDISC Definition Any bacterial organism that can be assigned to the species Prevotella brevis.

NCI Preferred Term Prevotella brevis

C86663 C86664 C86665 C86666 C86667 C86668 C86669

PREVOTELLA BUCCAE PREVOTELLA BUCCALIS PREVOTELLA CORPORIS PREVOTELLA DENTALIS PREVOTELLA DENTICOLA PREVOTELLA DISIENS PREVOTELLA HEPARINOLYTICA

Any bacterial organism that can be assigned to the species Prevotella buccae. Any bacterial organism that can be assigned to the species Prevotella buccalis. Any bacterial organism that can be assigned to the species Prevotella corporis. Any bacterial organism that can be assigned to the species Prevotella dentalis.

Prevotella buccae Prevotella buccalis Prevotella corporis Prevotella dentalis Prevotella denticola Prevotella disiens Prevotella heparinolytica

BACTEROIDES DENTICOLA BACTEROIDES DISIENS

Any bacterial organism that can be assigned to the species Prevotella denticola. Any bacterial organism that can be assigned to the species Prevotella disiens.

BACTEROIDES Any bacterial organism that can be assigned to the HEPARINOLYTI species Prevotella heparinolytica. CUS Any bacterial organism that can be assigned to the species Prevotella intermedia. A non-taxonomic grouping of bacteria assigned to the Prevotella genus that include the P. intermedia and P. nigrescens species. Any bacterial organism that can be assigned to the species Prevotella loescheii. BACTEROIDES MELANINOGE NICUS Any bacterial organism that can be assigned to the species Prevotella melaninogenica. Any bacterial organism that can be assigned to the species Prevotella nigrescens. BACTEROIDES ORALIS BACTEROIDES ORIS BACTEROIDES RUMINICOLA Any bacterial organism that can be assigned to the species Prevotella oralis. Any bacterial organism that can be assigned to the species Prevotella oris. Any bacterial organism that can be assigned to the species Prevotella ruminicola. Any bacterial organism that can be assigned to the species Prevotella tannerae. Any bacterial organism that can be assigned to the species Prevotella veroralis. Any bacteria that is not assigned to the species level but can be assigned to the Propionibacterium genus level.

C86670 C86671

PREVOTELLA INTERMEDIA BACTEROIDES INTERMEDIA PREVOTELLA INTERMEDIA/NIGRESCENS GROUP PREVOTELLA LOESCHEII PREVOTELLA MELANINOGENICA PREVOTELLA NIGRESCENS PREVOTELLA ORALIS PREVOTELLA ORIS PREVOTELLA RUMINICOLA PREVOTELLA TANNERAE PREVOTELLA VERORALIS PROPIONIBACTERIUM

Prevotella intermedia Prevotella intermedia/nigrescens Group Prevotella loescheii Prevotella melaninogenica

C86672 C86673

C86674 C86675 C86676 C86677 C86678 C86679 C86013

Prevotella nigrescens Prevotella oralis Prevotella oris Prevotella ruminicola Prevotella tannerae Prevotella veroralis Propionibacterium

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 297 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C14378

CDISC Submission Value PROPIONIBACTERIUM ACNES

CDISC Definition

NCI Preferred Term Propionibacterium acnes

BACILLUS Any bacterial organism that can be assigned to the ACNES; species Propionibacterium acnes. CORYNEBACTE RIUM ACNES; CORYNEBACTE RIUM PARVUM; C. PARVUM; CPARV Any bacterial organism that can be assigned to the species Propionibacterium avidum. CORYNEBACTE Any bacterial organism that can be assigned to the RIUM species Propionibacterium granulosum. GRANULOSUM ACTINOMYCES Any bacterial organism that can be assigned to the PROPIONICUS species Propionibacterium propionicum. Any bacteria that is not assigned to the species level but can be assigned to the Proteus genus level. Any bacterial organism that can be assigned to the species Proteus hauseri. PROVIDENCIA INCONSTANS Any bacterial organism that can be assigned to the species Proteus inconstans. Any bacterial organism that can be assigned to the species Proteus mirabilis. Any bacterial organism that can be assigned to the species Proteus myxofaciens. INDOLE NEGATIVE PROTEUS VULGARIS Any bacterial organism that can be assigned to the species Proteus penneri.

C86681 C86682

PROPIONIBACTERIUM AVIDUM PROPIONIBACTERIUM GRANULOSUM PROPIONIBACTERIUM PROPIONICUM PROTEUS PROTEUS HAUSERI PROTEUS INCONSTANS PROTEUS MIRABILIS PROTEUS MYXOFACIENS PROTEUS PENNERI

Propionibacterium avidum Propionibacterium granulosum

C86683 C76374 C86684 C84582 C86019 C86687 C86688

Propionibacterium propionicum Proteus Proteus hauseri Proteus inconstans Proteus mirabilis Proteus myxofaciens Proteus penneri

C85250 C86690 C86691 C86692 C86693 C86694

PROTEUS VULGARIS PROVIDENCIA PROVIDENCIA ALCALIFACIENS PROVIDENCIA HEIMBACHAE PROVIDENCIA RETTGERI PROVIDENCIA RUSTIGIANII PROVIDENCIA STUARTII PSEUDOMONAS

Any bacterial organism that can be assigned to the species Proteus vulgaris. Any bacteria that is not assigned to the species level but can be assigned to the Providencia genus level. Any bacterial organism that can be assigned to the species Providencia alcalifaciens. Any bacterial organism that can be assigned to the species Providencia heimbachae. Any bacterial organism that can be assigned to the species Providencia rettgeri. PROVIDENCIA Any bacterial organism that can be assigned to the ALCALIFACIEN species Providencia rustigianii. S BIOGROUP 3 Any bacterial organism that can be assigned to the species Providencia stuartii. Any bacteria that is not assigned to the species level but can be assigned to the Pseudomonas genus level.

Proteus vulgaris Providencia Providencia alcalifaciens Providencia heimbachae Providencia rettgeri Providencia rustigianii

C86695 C76375

Providencia stuartii Pseudomonas

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 298 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86696 C86697 C86699 C86962

CDISC Submission Value PSEUDOMONAS AERUGINOSA PSEUDOMONAS ALCALIGENES PSEUDOMONAS CHLORORAPHIS PSEUDOMONAS FLUORESCENS/PUTIDA GROUP PSEUDOMONAS LUTEOLA PSEUDOMONAS MENDOCINA PSEUDOMONAS MOSSELII PSEUDOMONAS ORYZIHABITANS PSEUDOMONAS PSEUDOALCALIGENES

CDISC Definition Any bacterial organism that can be assigned to the species Pseudomonas aeruginosa. Any bacterial organism that can be assigned to the species Pseudomonas alcaligenes. Any bacterial organism that can be assigned to the species Pseudomonas chlororaphis. A non-taxonomic grouping of bacteria assigned to the Pseudomonas genus that include the P. fluorescens and P. putida species.

NCI Preferred Term Pseudomonas aeruginosa Pseudomonas alcaligenes Pseudomonas chlororaphis Pseudomonas fluorescens/putida Group Pseudomonas luteola Pseudomonas mendocina Pseudomonas mosselii Pseudomonas oryzihabitans

C86701 C86702 C86703 C76319

CHRYSEOMON AS LUTEOLA CDC GROUP VB-2

Any bacterial organism that can be assigned to the species Pseudomonas luteola. Any bacterial organism that can be assigned to the species Pseudomonas mendocina. Any bacterial organism that can be assigned to the species Pseudomonas mosselii.

FLAVIMONAS ORYZIHABITA NS PSEUDOMONA S ALCALIGENES BIOTYPE B

Any bacterial organism that can be assigned to the species Pseudomonas oryzihabitans. Any bacterial organism that can be assigned to the species Pseudomonas pseudoalcaligenes.

C86704

Pseudomonas pseudoalcaligenes

C86705 C86706 C86707 C86708 C86709

PSEUDOMONAS PUTIDA PSEUDOMONAS STUTZERI PSYCHROBACTER PSYCHROBACTER IMMOBILIS PSYCHROBACTER PHENYLPYRUVICUS MORAXELLA PHENYLPYRU VICA; CDC GROUP M-2 PSEUDOMONA S GROUP VB-1

Any bacterial organism that can be assigned to the species Pseudomonas putida. Any bacterial organism that can be assigned to the species Pseudomonas stutzeri. Any bacteria that is not assigned to the species level but can be assigned to the Psychrobacter genus level. Any bacterial organism that can be assigned to the species Psychrobacter immobilis. Any bacterial organism that can be assigned to the species Psychrobacter phenylpyruvicus.

Pseudomonas putida Pseudomonas stutzeri Psychrobacter Psychrobacter immobilis Psychrobacter phenylpyruvicus

C86710 C86711 C86712 C86713

RAHNELLA RAHNELLA AQUATILIS RALSTONIA RALSTONIA PICKETTII

Any bacteria that is not assigned to the species level but can be assigned to the Rahnella genus level. Any bacterial organism that can be assigned to the species Rahnella aquatilis. Any bacteria that is not assigned to the species level but can be assigned to the Ralstonia genus level. BURKHOLDERI Any bacterial organism that can be assigned to the A PICKETTII; species Ralstonia pickettii. PSEUDOMONA S PICKETTII Any bacteria that is not assigned to the species level but can be assigned to the Raoultella genus level.

Rahnella Rahnella aquatilis Ralstonia Ralstonia pickettii

C86714

RAOULTELLA

Raoultella

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 299 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym KLEBSIELLA ORNITHINOLY TICA

NCI Code C86715

CDISC Submission Value RAOULTELLA ORNITHINOLYTICA RAOULTELLA PLANTICOLA RAOULTELLA TERRIGENA RHIZOBIUM RHODOCOCCUS RHODOCOCCUS EQUI RICKETTSIA RICKETTSIA AFRICAE RICKETTSIA FELIS RICKETTSIA JAPONICA RICKETTSIA PROWAZEKII RICKETTSIA RICKETTSII RICKETTSIA TYPHI ROSEOMONAS ROTHIA ROTHIA DENTOCARIOSA

CDISC Definition Any bacterial organism that can be assigned to the species Raoultella ornithinolytica. Any bacterial organism that can be assigned to the species Raoultella planticola.

NCI Preferred Term Raoultella ornithinolytica

C86716 C86717 C86718 C76378 C86719 C76379 C86720 C86721 C86722 C86723 C86724 C86725 C86726 C86727 C86728

Raoultella planticola Raoultella terrigena Rhizobium Rhodococcus Rhodococcus equi Rickettsia Rickettsia africae Rickettsia felis Rickettsia japonica Rickettsia prowazekii Rickettsia rickettsii Rickettsia typhi Roseomonas Rothia Rothia dentocariosa

KLEBSIELLA TERRIGENA

Any bacterial organism that can be assigned to the species Raoultella terrigena. Any bacteria that is not assigned to the species level but can be assigned to the Rhizobium genus level. Any bacteria that is not assigned to the species level but can be assigned to the Rhodococcus genus level.

CORYNEBACTE Any bacterial organism that can be assigned to the RIUM EQUI species Rhodococcus equi. Any bacteria that is not assigned to the species level but can be assigned to the Rickettsia genus level. Any bacterial organism that can be assigned to the species Rickettsia africae. Any bacterial organism that can be assigned to the species Rickettsia felis. Any bacterial organism that can be assigned to the species Rickettsia japonica. Any bacterial organism that can be assigned to the species Rickettsia prowazekii. Any bacterial organism that can be assigned to the species Rickettsia rickettsii. Any bacterial organism that can be assigned to the species Rickettsia typhi. Any bacteria that is not assigned to the species level but can be assigned to the Roseomonas genus level. Any bacteria that is not assigned to the species level but can be assigned to the Rothia genus level. NOCARDIA DENTOCARIOS A STOMATOCOC CUS MUCILAGINOS US Any bacterial organism that can be assigned to the species Rothia dentocariosa. Any bacterial organism that can be assigned to the species Rothia mucilaginosa.

C76382

ROTHIA MUCILAGINOSA

Rothia mucilaginosa

C86729 C86730

RUMINOCOCCUS RUMINOCOCCUS PRODUCTUS SALMONELLA PEPTOSTREPT OCOCCUS PRODUCTUS SALMONELLA SEROGROUP D (NOT S. TYPHI)

Any bacteria that is not assigned to the species level but can be assigned to the Ruminococcus genus level. Any bacterial organism that can be assigned to the species Ruminococcus productus. Any bacteria that is not assigned to the species level but can be assigned to the Salmonella genus level.

Ruminococcus Ruminococcus productus

C76380

Salmonella

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 300 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C91842 C86731 C86910 C91844 C86913 C91845 C91846 C91847 C86915 C86918 C86919 C86921 C86922 C86924 C86925 C86926 C86927 C86732 C86733 C86734 C86010 C86736

CDISC Submission Value SALMONELLA BONGORI SALMONELLA ENTERICA SALMONELLA ENTERICA SUBSP. ARIZONAE SALMONELLA ENTERICA SUBSP. DIARIZONAE SALMONELLA ENTERICA SUBSP. ENTERICA SALMONELLA ENTERICA SUBSP. HOUTENAE SALMONELLA ENTERICA SUBSP. INDICA SALMONELLA ENTERICA SUBSP. SALAMAE SALMONELLA SEROTYPE CHOLERAESUIS SALMONELLA SEROTYPE DUBLIN SALMONELLA SEROTYPE ENTERITIDIS SALMONELLA SEROTYPE NEWPORT SALMONELLA SEROTYPE PARATYPHI A SALMONELLA SEROTYPE PARATYPHI B SALMONELLA SEROTYPE PARATYPHI C SALMONELLA SEROTYPE TYPHI SALMONELLA SEROTYPE TYPHIMURIUM SELENOMONAS SELENOMONAS NOXIA SELENOMONAS SPUTIGENA SERRATIA SERRATIA FICARIA

CDISC Definition Any bacterial organism that can be assigned to the species Salmonella bongori. Any bacterial organism that can be assigned to the species Salmonella enterica. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies arizonae. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies diarizonae. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies enterica. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies houtenae. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies indica. Any bacterial organism that can be assigned to the species Salmonella enterica subspecies salamae. Any bacterial organism that can be assigned to the genus Salmonella with serotype Choleraesuis. Any bacterial organism that can be assigned to the genus Salmonella with serotype Dublin. Any bacterial organism that can be assigned to the genus Salmonella with serotype Enteritidis. Any bacterial organism that can be assigned to the genus Salmonella with serotype Newport. Any bacterial organism that can be assigned to the genus Salmonella with serotype Paratyphi A. Any bacterial organism that can be assigned to the genus Salmonella with serotype Paratyphi B. Any bacterial organism that can be assigned to the genus Salmonella with serotype Paratyphi C. Any bacterial organism that can be assigned to the genus Salmonella with serotype Typhi. Any bacterial organism that can be assigned to the genus Salmonella with serotype Typhimurium. Any bacteria that is not assigned to the species level but can be assigned to the Selenomonas genus level. Any bacterial organism that can be assigned to the species Selenomonas noxia. Any bacterial organism that can be assigned to the species Selenomonas sputigena.

NCI Preferred Term Salmonella bongori Salmonella enterica Salmonella enterica subsp arizonae Salmonella enterica subsp diarizonae Salmonella enterica subsp enterica Salmonella enterica subsp houtenae Salmonella enterica subsp indica Salmonella enterica subsp salamae Salmonella Serotype Choleraesuis Salmonella Serotype Dublin Salmonella Serotype Enteritidis Salmonella Serotype Newport Salmonella Serotype Paratyphi A Salmonella Serotype Paratyphi B Salmonella Serotype Paratyphi C Salmonella Serotype Typhi Salmonella Serotype Typhimurium Selenomonas Selenomonas noxia Selenomonas sputigena Serratia Serratia ficaria

SERRATIA

Any bacteria that is not assigned to the species level but can be assigned to the Serratia genus level. Any bacterial organism that can be assigned to the species Serratia ficaria.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 301 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86737 C86738

CDISC Submission Value SERRATIA FONTICOLA SERRATIA LIQUEFACIENS

CDISC Definition Any bacterial organism that can be assigned to the species Serratia fonticola.

NCI Preferred Term Serratia fonticola Serratia liquefaciens

ENTEROBACTE Any bacterial organism that can be assigned to the R species Serratia liquefaciens. LIQUEFACIENS S. MARCESCENS Any bacterial organism that can be assigned to the species Serratia marcescens. Any bacterial organism that can be assigned to the species Serratia odorifera. Any bacterial organism that can be assigned to the species Serratia plymuthica. SERRATIA MARINORUBR A Any bacterial organism that can be assigned to the species Serratia rubidaea. Any bacteria that is not assigned to the species level but can be assigned to the Shewanella genus level. ALTEROMONA Any bacterial organism that can be assigned to the S species Shewanella putrefaciens. PUTREFACIENS ; PSEUDOMONA S PUTREFACIENS Any bacteria that is not assigned to the species level but can be assigned to the Shigella genus level. SHIGELLA BIOGROUP C SHIGELLA BIOGROUP A SHIGELLA BIOGROUP B SHIGELLA BIOGROUP D Any bacterial organism that can be assigned to the species Shigella boydii. Any bacterial organism that can be assigned to the species Shigella dysenteriae. Any bacterial organism that can be assigned to the species Shigella flexneri. Any bacterial organism that can be assigned to the species Shigella sonnei. Any bacteria that is not assigned to the species level but can be assigned to the Sphingobacterium genus level. FLAVOBACTER Any bacterial organism that can be assigned to the IUM MIZUTAE species Sphingobacterium mizutaii. CDC GROUP IIK-2 CDC GROUP IIK-3 Any bacterial organism that can be assigned to the species Sphingobacterium multivorum. Any bacterial organism that can be assigned to the species Sphingobacterium spiritivorum.

C14272 C86739 C86740 C86741

SERRATIA MARCESCENS SERRATIA ODORIFERA SERRATIA PLYMUTHICA SERRATIA RUBIDAEA

Serratia marcescens Serratia odorifera Serratia plymuthica Serratia rubidaea

C86742 C86743

SHEWANELLA SHEWANELLA PUTREFACIENS

Shewanella Shewanella putrefaciens

C76381 C86744 C86745 C86746 C86747 C86957

SHIGELLA SHIGELLA BOYDII SHIGELLA DYSENTERIAE SHIGELLA FLEXNERI SHIGELLA SONNEI SPHINGOBACTERIUM

Shigella Shigella boydii Shigella dysenteriae Shigella flexneri Shigella sonnei Sphingobacterium

C86958 C86959 C86960 C86961

SPHINGOBACTERIUM MIZUTAII SPHINGOBACTERIUM MULTIVORUM SPHINGOBACTERIUM SPIRITIVORUM SPHINGOBACTERIUM THALPOPHILUM

Sphingobacterium mizutaii Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingobacterium thalpophilum

FLAVOBACTER Any bacterial organism that can be assigned to the IUM species Sphingobacterium thalpophilum. THALPOPHILU M

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 302 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86748 C86749

CDISC Submission Value SPHINGOMONAS SPHINGOMONAS PAUCIMOBILIS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Sphingomonas genus level.

NCI Preferred Term Sphingomonas Sphingomonas paucimobilis

CDC GROUP IIK-1; PSEUDOMONA S PAUCIMOBILIS

Any bacterial organism that can be assigned to the species Sphingomonas paucimobilis.

C62583 C86750 C50921 C86751 C86752 C86753 C86754 C86755 C86756 C86757 C86758 C86759 C86760 C86761

STAPHYLOCOCCUS STAPHYLOCOCCUS ARLETTAE STAPHYLOCOCCUS AUREUS STAPHYLOCOCCUS AURICULARIS STAPHYLOCOCCUS CAPITIS STAPHYLOCOCCUS CAPRAE STAPHYLOCOCCUS CARNOSUS STAPHYLOCOCCUS CHROMOGENES STAPHYLOCOCCUS COHNII STAPHYLOCOCCUS EPIDERMIDIS STAPHYLOCOCCUS EQUORUM STAPHYLOCOCCUS FELIS STAPHYLOCOCCUS GALLINARUM STAPHYLOCOCCUS HAEMOLYTICUS STAPHYLOCOCCUS HOMINIS STAPH. AUREUS

Any bacteria that is not assigned to the species level but can be assigned to the Staphylococcus genus level. Any bacterial organism that can be assigned to the species Staphylococcus arlettae. Any bacterial organism that can be assigned to the species Staphylococcus aureus. Any bacterial organism that can be assigned to the species Staphylococcus auricularis. Any bacterial organism that can be assigned to the species Staphylococcus capitis. Any bacterial organism that can be assigned to the species Staphylococcus caprae. Any bacterial organism that can be assigned to the species Staphylococcus carnosus. Any bacterial organism that can be assigned to the species Staphylococcus chromogenes. Any bacterial organism that can be assigned to the species Staphylococcus cohnii. STAPHYLOCOC Any bacterial organism that can be assigned to the CUS ALBUS species Staphylococcus epidermidis. Any bacterial organism that can be assigned to the species Staphylococcus equorum. Any bacterial organism that can be assigned to the species Staphylococcus felis. Any bacterial organism that can be assigned to the species Staphylococcus gallinarum. STAPH. Any bacterial organism that can be assigned to the HAEMOLYTICU species Staphylococcus haemolyticus. S COAGULASE Any bacterial organism that can be assigned to the NEGATIVE species Staphylococcus hominis. STAPHYLOCOC CUS HOMINIS Any bacterial organism that can be assigned to the species Staphylococcus hyicus. Any bacterial organism that can be assigned to the species Staphylococcus intermedius. Any bacterial organism that can be assigned to the species Staphylococcus kloosii.

Staphylococcus Staphylococcus arlettae Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae Staphylococcus carnosus Staphylococcus chromogenes Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus equorum Staphylococcus felis Staphylococcus gallinarum Staphylococcus haemolyticus

C86762

Staphylococcus hominis

C86763 C86764 C86765

STAPHYLOCOCCUS HYICUS STAPHYLOCOCCUS INTERMEDIUS STAPHYLOCOCCUS KLOOSII

Staphylococcus hyicus Staphylococcus intermedius Staphylococcus kloosii

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 303 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86766 C86767 C86768 C86769

CDISC Submission Value STAPHYLOCOCCUS LENTUS STAPHYLOCOCCUS LUGDUNENSIS STAPHYLOCOCCUS PASTEURI STAPHYLOCOCCUS SACCHAROLYTICUS STAPHYLOCOCCUS SAPROPHYTICUS STAPHYLOCOCCUS SCHLEIFERI STAPHYLOCOCCUS SCIURI STAPHYLOCOCCUS SIMULANS STAPHYLOCOCCUS WARNERI STAPHYLOCOCCUS XYLOSUS STENOTROPHOMONAS

CDISC Definition Any bacterial organism that can be assigned to the species Staphylococcus lentus. Any bacterial organism that can be assigned to the species Staphylococcus lugdunensis. Any bacterial organism that can be assigned to the species Staphylococcus pasteuri.

NCI Preferred Term Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus pasteuri Staphylococcus saccharolyticus

PEPTOCOCCUS Any bacterial organism that can be assigned to the SACCHAROLYT species Staphylococcus saccharolyticus. ICUS MICROCOCCU S SUBGROUP 3 Any bacterial organism that can be assigned to the species Staphylococcus saprophyticus. Any bacterial organism that can be assigned to the species Staphylococcus schleiferi. Any bacterial organism that can be assigned to the species Staphylococcus sciuri. Any bacterial organism that can be assigned to the species Staphylococcus simulans. Any bacterial organism that can be assigned to the species Staphylococcus warneri. Any bacterial organism that can be assigned to the species Staphylococcus xylosus. STENOTROPHO Any bacteria that is not assigned to the species level MONAS but can be assigned to the Stenotrophomonas genus level. PSEUDOMONA Any bacterial organism that can be assigned to the S species Stenotrophomonas maltophilia. MALTOPHILIA; XANTHOMONA S MALTOPHILIA Any bacteria that is not assigned to the species level but can be assigned to the Streptobacillus genus level. HAVERHILLIA MULTIFORMIS STREPTOCOCC I SP. Any bacterial organism that can be assigned to the species Streptobacillus moniliformis. Any bacteria that is not assigned to the species level but can be assigned to the Streptococcus genus level. Any bacterial organism that can be assigned to the species Streptococcus acidominimus. STREPT. GP B(AGALACT) Any bacterial organism that can be assigned to the species Streptococcus agalactiae. Any bacterial organism that can be assigned to the species Streptococcus alactolyticus. ALPHA-HEMOL YTIC STREPTOCOCC US A bacteria that is assigned to the genus Streptococcus that is able to reduce the iron content in hemoglobin in red blood cells, thus producing green-colored colonies on blood agar plates.

C86770 C86771 C86772 C86773 C86774 C86775 C86776

Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Stenotrophomonas

C76377

STENOTROPHOMONAS MALTOPHILIA

Stenotrophomonas maltophilia

C86777 C86778 C76383 C86779 C86780 C86781 C86141

STREPTOBACILLUS STREPTOBACILLUS MONILIFORMIS STREPTOCOCCUS STREPTOCOCCUS ACIDOMINIMUS STREPTOCOCCUS AGALACTIAE STREPTOCOCCUS ALACTOLYTICUS STREPTOCOCCUS ALPHA-HEMOLYTIC

Streptobacillus Streptobacillus moniliformis Streptococcus Streptococcus acidominimus Streptococcus agalactiae Streptococcus alactolyticus Alpha-Hemolytic Streptococcus

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 304 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86782 C86783 C86190

CDISC Submission Value STREPTOCOCCUS ANGINOSIS STREPTOCOCCUS ANGINOSUS GROUP STREPTOCOCCUS BETA-HEMOLYTIC

CDISC Definition Any bacterial organism that can be assigned to the species Streptococcus anginosis. A bacteria that belongs to the Anginosus group of the genus Streptococcus.

NCI Preferred Term Streptococcus anginosis Streptococcus anginosus Group Beta-Hemolytic Streptococcus

BETA-HEMOLY TIC STREPTOCOCC US

A bacteria that is assigned to the genus Streptococcus that is able to facilitate the complete rupturing of red blood cells, thus producing wide, clear, zones around colonies on blood agar plates. Any bacterial organism that can be assigned to the species Streptococcus bovis. A bacteria that belongs to the Bovis group of the genus Streptococcus.

C86784 C86785 C86786

STREPTOCOCCUS BOVIS STREPTOCOCCUS BOVIS GROUP STREPTOCOCCUS CANIS STREPTOCOCC US DYSGALACTIA E

Streptococcus bovis Streptococcus bovis Group Streptococcus canis

Any bacterial organism that can be assigned to the species Streptococcus canis.

C86787 C86788 C91848

STREPTOCOCCUS CONSTELLATUS STREPTOCOCCUS CRISTATUS STREPTOCOCCUS DYSGALACTIAE SUBSP. DYSGALACTIAE STREPTOCOCCUS DYSGALACTIAE SUBSP. EQUISIMILIS STREPTOCOCCUS EQUI STREPTOCOCCUS EQUINUS STREPTOCOCCUS GALLOLYTICUS STREPTOCOCCUS GAMMA-HEMOLYTIC STREPTOCOCC US EQUISIMILIS

Any bacterial organism that can be assigned to the species Streptococcus constellatus. Any bacterial organism that can be assigned to the species Streptococcus cristatus. Any bacterial organism that can be assigned to the species Streptococcus dysgalactiae subspecies dysgalactiae. Any bacterial organism that can be assigned to the species Streptococcus dysgalactiae subspecies equisimilis. Any bacterial organism that can be assigned to the species Streptococcus equi. Any bacterial organism that can be assigned to the species Streptococcus equinus. Any bacterial organism that can be assigned to the species Streptococcus gallolyticus. GAMMA-HEMO A bacteria that is assigned to the genus Streptococcus LYTIC that is unable to facilitate red blood cell lysis. STREPTOCOCC US Any bacterial organism that can be assigned to the species Streptococcus gordonii. Any bacterial organism that can be assigned to the species Streptococcus infantarius. Any bacterial organism that can be assigned to the species Streptococcus intermedius. Any bacterial organism that can be assigned to the species Streptococcus milleri. A bacteria that belongs to the Milleri group of the genus Streptococcus.

Streptococcus constellatus Streptococcus cristatus Streptococcus dysgalactiae subsp dysgalactiae Streptococcus dysgalactiae subsp equisimilis Streptococcus equi Streptococcus equinus Streptococcus gallolyticus Gamma-Hemolytic Streptococcus

C86906

C86789 C86790 C86791 C86408

C86792 C86793 C86794 C86795 C86796

STREPTOCOCCUS GORDONII STREPTOCOCCUS INFANTARIUS STREPTOCOCCUS INTERMEDIUS STREPTOCOCCUS MILLERI STREPTOCOCC US MILLERI I STREPTOCOCCUS MILLERI GROUP

Streptococcus gordonii Streptococcus infantarius Streptococcus intermedius Streptococcus milleri Streptococcus milleri Group

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 305 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86797 C86798 C86799 C86800

CDISC Submission Value STREPTOCOCCUS MITIS GROUP STREPTOCOCCUS MUTANS GROUP STREPTOCOCCUS ORALIS STREPTOCOCCUS PARASANGUINIS STREPTOCOCCUS PNEUMONIAE STREPTOCOCCUS PORCINUS STREPTOCOCCUS PYOGENES

CDISC Definition A bacteria that belongs to the Mitis group of the genus Streptococcus. A bacteria that belongs to the Mutans group of the genus Streptococcus. Any bacterial organism that can be assigned to the species Streptococcus oralis.

NCI Preferred Term Streptococcus mitis Group Streptococcus mutans Group Streptococcus oralis Streptococcus parasanguinis

STREPTOCOCC US PARASANGUIS DIPLOCOCCUS PNEUMONIAE

Any bacterial organism that can be assigned to the species Streptococcus parasanguinis. Any bacterial organism that can be assigned to the species Streptococcus pneumoniae. Any bacterial organism that can be assigned to the species Streptococcus porcinus.

C76384 C86802 C86803

Streptococcus pneumoniae Streptococcus porcinus Streptococcus pyogenes

GROUP A Any bacterial organism that can be assigned to the BETA-HEMOLY species Streptococcus pyogenes. TIC STREPTOCOCC US PYOGENES Any bacterial organism that can be assigned to the species Streptococcus salivarius. A bacteria that belongs to the Salivarius group of the genus Streptococcus. STREPTOCOCC US SANGUIS Any bacterial organism that can be assigned to the species Streptococcus sanguinis. Any bacterial organism that can be assigned to the species Streptococcus suis. Any bacterial organism that can be assigned to the species Streptococcus thermophilus. Any bacterial organism that can be assigned to the species Streptococcus uberis. Any bacterial organism that can be assigned to the species Streptococcus vestibularis. STREPTOCOCC US VIRIDANS; VIRIDANS STREPTOCOCC US A non-taxonomic grouping of species within the Streptococcus genus that are alpha-hemolytic and do not express Lancefield antigens.

C86804 C86805 C86806 C86807 C86808 C86809 C86810 C86811

STREPTOCOCCUS SALIVARIUS STREPTOCOCCUS SALIVARIUS GROUP STREPTOCOCCUS SANGUINIS STREPTOCOCCUS SUIS STREPTOCOCCUS THERMOPHILUS STREPTOCOCCUS UBERIS STREPTOCOCCUS VESTIBULARIS STREPTOCOCCUS VIRIDANS GROUP

Streptococcus salivarius Streptococcus salivarius Group Streptococcus sanguinis Streptococcus suis Streptococcus thermophilus Streptococcus uberis Streptococcus vestibularis Streptococcus viridans Group

C14278 C86812 C86813 C86814

STREPTOMYCES STREPTOMYCES ALBUS STREPTOMYCES GRISEUS STREPTOMYCES SOMALIENSIS

Any bacteria that is not assigned to the species level but can be assigned to the Streptomyces genus level. Any bacterial organism that can be assigned to the species Streptomyces albus. Any bacterial organism that can be assigned to the species Streptomyces griseus. Any bacterial organism that can be assigned to the species Streptomyces somaliensis.

Streptomyces Streptomyces albus Streptomyces griseus Streptomyces somaliensis

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 306 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86956 C86815 C86816 C86817 C86818 C86819 C86820

CDISC Submission Value SUTTERELLA SUTTONELLA SUTTONELLA INDOLOGENES TATLOCKIA MICDADEI TATUMELLA TATUMELLA PTYSEOS TETRAGENOCOCCUS

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Sutterella genus level. Any bacteria that is not assigned to the species level but can be assigned to the Suttonella genus level.

NCI Preferred Term Sutterella Suttonella Suttonella indologenes Tatlockia micdadei Tatumella Tatumella ptyseos Tetragenococcus

KINGELLA INDOLOGENES LEGIONELLA MICDADEI

Any bacterial organism that can be assigned to the species Suttonella indologenes. Any bacterial organism that can be assigned to the species Legionella micdadei. Any bacteria that is not assigned to the species level but can be assigned to the Tatumella genus level.

CDC GROUP EF-9

Any bacterial organism that can be assigned to the species Tatumella ptyseos. Any bacteria that is not assigned to the species level but can be assigned to the Tetragenococcus genus level.

C86821 C86907 C86908 C86822 C86823 C76385 C86825 C91850 C91849 C86909 C86826 C86827 C86828 C86829 C86830

TETRAGENOCOCCUS SOLITARIUS TISSIERELLA TISSIERELLA PRAEACUTA TRABULSIELLA TRABULSIELLA GUAMENSIS TREPONEMA TREPONEMA PALLIDUM TREPONEMA PALLIDUM SUBSP. ENDEMICUM TREPONEMA PALLIDUM SUBSP. PALLIDUM TREPONEMA PALLIDUM SUBSP. PERTENUE TROPHERYMA TROPHERYMA WHIPPLEI TSUKAMURELLA TSUKAMURELLA PAUROMETABOLUM TURICELLA

ENTEROCOCC Any bacterial organism that can be assigned to the US SOLITARIUS species Tetragenococcus solitarius. Any bacteria that is not assigned to the species level but can be assigned to the Tissierella genus level. Any bacterial organism that can be assigned to the species Tissierella praeacuta. Any bacteria that is not assigned to the species level but can be assigned to the Trabulsiella genus level. CDC ENTERIC GROUP 90 Any bacterial organism that can be assigned to the species Trabulsiella guamensis. Any bacteria that is not assigned to the species level but can be assigned to the Treponema genus level. Any bacterial organism that can be assigned to the species Treponema pallidum. Any bacterial organism that can be assigned to the species Treponema pallidum subspecies endemicum. Any bacterial organism that can be assigned to the species Treponema pallidum subspecies pallidum. TREPONEMA PERTENUE Any bacterial organism that can be assigned to the species Treponema pallidum and subspecies pertenue. Any bacteria that is not assigned to the species level but can be assigned to the Tropheryma genus level. Any bacterial organism that can be assigned to the species Tropheryma whipplei. Any bacteria that is not assigned to the species level but can be assigned to the Tsukamurella genus level. GORDONA AURANTIACA Any bacterial organism that can be assigned to the species Tsukamurella paurometabolum. Any bacteria that is not assigned to the species level but can be assigned to the Turicella genus level.

Tetragenococcus solitarius Tissierella Tissierella praeacuta Trabulsiella Trabulsiella guamensis Treponema Treponema pallidum Treponema pallidum subsp endemicum Treponema pallidum subsp pallidum Treponema pallidum subsp pertenue Tropheryma Tropheryma whipplei Tsukamurella Tsukamurella paurometabolum Turicella

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C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym RHODOCOCCU S AURANTIAZUS

NCI Code C86831

CDISC Submission Value TURICELLA OTITIDIS

CDISC Definition Any bacterial organism that can be assigned to the species Turicella otitidis. Any bacteria that is not assigned to the species level but can be assigned to the Ureaplasma genus level.

NCI Preferred Term Turicella otitidis

C86832 C86833 C86834 C86835 C86836 C86837 C86838 C86839 C76386 C86840 C86841 C86842 C86843

UREAPLASMA UREAPLASMA UREALYTICUM VAGOCOCCUS VARIBACULUM VARIBACULUM CAMBRIENSE VEILLONELLA VEILLONELLA DISPAR VEILLONELLA PARVULA VIBRIO VIBRIO ALGINOLYTICUS VIBRIO CHOLERAE VIBRIO FLUVIALIS VIBRIO FURNISSII VIBRIO COMMA CDC GROUP EF-6 VIBRIO FLUVIALIS BIOGROUP 2 CDC ENTERIC GROUP 16 SUCROSE NEGATIVE VIBRIO CHOLERAE

Ureaplasma Ureaplasma urealyticum Vagococcus Varibaculum Varibaculum cambriense Veillonella Veillonella dispar Veillonella parvula Vibrio Vibrio alginolyticus Vibrio cholerae Vibrio fluvialis Vibrio furnissii

T-MYCOPLASM Any bacterial organism that can be assigned to the A species Ureaplasma urealyticum. Any bacteria that is not assigned to the species level but can be assigned to the Vagococcus genus level. Any bacteria that is not assigned to the species level but can be assigned to the Varibaculum genus level. Any bacterial organism that can be assigned to the species Varibaculum cambriense. Any bacteria that is not assigned to the species level but can be assigned to the Veillonella genus level. Any bacterial organism that can be assigned to the species Veillonella dispar. Any bacterial organism that can be assigned to the species Veillonella parvula. Any bacteria that is not assigned to the species level but can be assigned to the Vibrio genus level. Any bacterial organism that can be assigned to the species Vibrio alginolyticus. Any bacterial organism that can be assigned to the species Vibrio cholerae. Any bacterial organism that can be assigned to the species Vibrio fluvialis. Any bacterial organism that can be assigned to the species Vibrio furnissii. Any bacterial organism that can be assigned to the species Vibrio metschnikovii. Any bacterial organism that can be assigned to the species Vibrio mimicus.

C86844 C86845

VIBRIO METSCHNIKOVII VIBRIO MIMICUS

Vibrio metschnikovii Vibrio mimicus

C86846 C86847 C86848 C86849

VIBRIO PARAHAEMOLYTICUS VIBRIO VULNIFICUS WEEKSELLA WEEKSELLA VIROSA BENECKEA VULNIFICA

Any bacterial organism that can be assigned to the species Vibrio parahaemolyticus. Any bacterial organism that can be assigned to the species Vibrio vulnificus. Any bacteria that is not assigned to the species level but can be assigned to the Weeksella genus level. CDC GROUP IIF Any bacterial organism that can be assigned to the species Weeksella virosa.

Vibrio parahaemolyticus Vibrio vulnificus Weeksella Weeksella virosa

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C85491 - MICROORG - Microorganism Codelist extensible: Yes
CDISC Synonym

NCI Code C86850 C86851 C86852 C86853 C86854

CDISC Submission Value WOLINELLA WOLINELLA SUCCINOGENES YERSINIA YERSINIA ALDOVAE YERSINIA BERCOVIERI

CDISC Definition Any bacteria that is not assigned to the species level but can be assigned to the Wolinella genus level. Any bacterial organism that can be assigned to the species Wolinella succinogenes. Any bacteria that is not assigned to the species level but can be assigned to the Yersinia genus level. Any bacterial organism that can be assigned to the species Yersinia aldovae.

NCI Preferred Term Wolinella Wolinella succinogenes Yersinia Yersinia aldovae Yersinia bercovieri

YERSINIA Any bacterial organism that can be assigned to the ENTEROLITICA species Yersinia bercovieri. BIOGROUP 3B PASTEURELLA Any bacterial organism that can be assigned to the ENTEROCOLITI species Yersinia enterocolitica. CA Any bacterial organism that can be assigned to the species Yersinia frederiksenii. Any bacterial organism that can be assigned to the species Yersinia intermedia. Any bacterial organism that can be assigned to the species Yersinia kristensenii. YERSINIA Any bacterial organism that can be assigned to the ENTEROLITICA species Yersinia mollaretii. BIOGROUP 3A PASTEURELLA PESTIS Any bacterial organism that can be assigned to the species Yersinia pestis.

C86855

YERSINIA ENTEROCOLITICA YERSINIA FREDERIKSENII YERSINIA INTERMEDIA YERSINIA KRISTENSENII YERSINIA MOLLARETII

Yersinia enterocolitica

C86856 C86857 C86858 C86859

Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia mollaretii

C86860 C86861

YERSINIA PESTIS YERSINIA PSEUDOTUBERCULOSIS YERSINIA ROHDEI YERSINIA RUCKERI YOKENELLA YOKENELLA REGENSBURGEI ZIMMERMANNELLA

Yersinia pestis Yersinia pseudotuberculosis

PASTEURELLA Any bacterial organism that can be assigned to the PSEUDOTUBER species Yersinia pseudotuberculosis. CULOSIS Any bacterial organism that can be assigned to the species Yersinia rohdei. Any bacterial organism that can be assigned to the species Yersinia ruckeri. Any bacteria that is not assigned to the species level but can be assigned to the Yokenella genus level. CDC ENTERIC GROUP 45 Any bacterial organism that can be assigned to the species Yokenella regensburgei. Any bacteria that is not assigned to the species level but can be assigned to the Zimmermannella genus level. Any bacterial organism that can be assigned to the species Zimmermannella alba. Any bacterial organism that can be assigned to the species Zimmermannella bifida.

C86862 C86863 C86864 C86865 C86866

Yersinia rohdei Yersinia ruckeri Yokenella Yokenella regensburgei Zimmermannella

C86867 C86868

ZIMMERMANNELLA ALBA ZIMMERMANNELLA BIFIDA

Zimmermannella alba Zimmermannella bifida

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C85495 - MSRESCAT - Microbiology Susceptibility Testing Result Category Codelist extensible: No
CDISC Synonym Intermediate

NCI Code C85560

CDISC Submission Value INTERMEDIATE

CDISC Definition The growth of microorganisms may be inhibited by antimicrobials that approach usually attainable blood and tissue concentrations. The response rates may be lower than for susceptible isolates. This category also includes a buffer zone, which should prevent small, uncontrolled, technical factors from causing major discrepancies in interpretations, especially for drugs with narrow pharmacotoxicity margins. A category used for microorganisms that have only a susceptible interpretive criteria, but not an intermediate or resistant interpretive category (i.e., susceptible-only interpretive category). This category may be applied to new antimicrobial agents for which no resistant microorganisms have been encountered at the time the initial interpretive criteria are determined. Microorganisms that test with an MIC above or a zone measurement below the susceptible interpretive criteria are designated as nonsusceptible. A designation of nonsusceptible does not necessarily mean that a resistance mechanism(s) exists in the microorganism. Determination of a value is not relevant in the current context. (NCI) The growth of microorganisms are not inhibited by the usually achievable concentrations of the antimicrobial agent with normal dosages, and/or microorganisms demonstrate MICs or zone diameters that fall in the range where specific microbial resistance mechanisms (e.g. Beta-lactamases) are likely, and clinical efficacy of the agent against the microorganism has not been reliably shown in treatment studies. The growth of microorganisms are inhibited by the usually achievable concentrations of antimicrobial agent when the recommended dosage is used for the site of infection. The growth of microorganisms may be inhibited when higher than normal dosages of an antimicrobial agent are used and maximal possible blood concentration of the antimicrobial agent is achieved. Not known, not observed, not recorded, or refused. (NCI)

NCI Preferred Term Antimicrobial Intermediate Susceptibility Result

C85561

NONSUSCEPTIBLE

Non Susceptible

Antimicrobial Nonsusceptibility Result

C48660 C85562

NOT APPLICABLE RESISTANT

Not Applicable; NA Resistant

Not Applicable Antimicrobial Resistance Result

C85563

SUSCEPTIBLE

Susceptible

Antimicrobial Susceptibility Result

C85559

SUSCEPTIBLE-DOSE DEPENDENT

Susceptible-Dos e Dependent

Antimicrobial Dose Dependent Susceptibility Result

C17998

UNKNOWN

U; Unknown

Unknown

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CDISC SDTM Controlled Terminology, 2012-06-29


C78738 - NCF - Never/Current/Former Classification Codelist extensible: Yes
CDISC Synonym

NCI Code C25471 C25627 C70543

CDISC Submission Value CURRENT FORMER NEVER

CDISC Definition Occurring in or belonging to the present time. (NCI) Current

NCI Preferred Term

Previous

Occurring prior to something else. (NCI) Not ever; at no time in the past.

Previous Never

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CDISC SDTM Controlled Terminology, 2012-06-29


C66727 - NCOMPLT - Completion/Reason for Non-Completion Codelist extensible: Yes
CDISC Synonym

NCI Code C41331

CDISC Submission Value ADVERSE EVENT

CDISC Definition Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary) To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI) The absence of life or state of being dead. (NCI) The lack of expected or desired effect related to a therapy. (NCI) The loss or lack of continuation of a subject to follow-up. An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)

NCI Preferred Term Adverse Event

C25250

COMPLETED

Complete

C28554 C48226 C48227 C49631

DEATH LACK OF EFFICACY LOST TO FOLLOW-UP NON-COMPLIANCE WITH STUDY DRUG OTHER PHYSICIAN DECISION Other

Death Lack of Efficacy Lost To Follow-up Non-Compliance With Study Drug

C17649 C48250

Different than the one(s) previously specified or mentioned. (NCI) A position, opinion or judgment reached after consideration by a physician with reference to subject. (NCI) Pregnancy is the state or condition of having a developing embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. (NCI) A disease process that is increasing in scope or severity. (NCI) An event or decision that stands in contrast to the guidelines set out by the protocol. (NCI) A healing process and/or an outcome implying relative health. The term is typically used in the context of direct and indirect effects of sickness or injury. (NCI) The potential subject who does not meet one or more criteria required for participation in a trial. An indication that a clinical study was stopped by its sponsor. (NCI) A problem with some technical aspect of a clinical study, usually related to an instrument. (NCI)

Other Physician Decision

C25742

PREGNANCY

Pregnancy

C35571 C48251 C25746

PROGRESSIVE DISEASE PROTOCOL VIOLATION RECOVERY

Progressive Disease Protocol Violation Recovery

C49628 C49632 C49633

SCREEN FAILURE STUDY TERMINATED BY SPONSOR TECHNICAL PROBLEMS

Trial Screen Failure Study Terminated By Sponsor Technical Problem

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CDISC SDTM Controlled Terminology, 2012-06-29


C66727 - NCOMPLT - Completion/Reason for Non-Completion Codelist extensible: Yes
CDISC Synonym

NCI Code C102355 C49634

CDISC Submission Value WITHDRAWAL BY PARENT/GUARDIAN WITHDRAWAL BY SUBJECT

CDISC Definition An indication that a study participant has been removed from the study by the parent or legal guardian. An indication that a study participant has removed itself from the study. (NCI)

NCI Preferred Term Study Subject Withdrawal by Parent or Guardian Withdrawal by Subject

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CDISC SDTM Controlled Terminology, 2012-06-29


C66789 - ND - Not Done Codelist extensible: No
CDISC Synonym

NCI Code C49484

CDISC Submission Value NOT DONE

CDISC Definition Indicates a task, process or examination that has either not been initiated or completed. (NCI)

NCI Preferred Term Not Done

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C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym ADAMANTINO MA ADENOACANT HOMA

NCI Code C7644

CDISC Submission Value ADAMANTINOMA, MALIGNANT ADENOACANTHOMA, MALIGNANT

CDISC Definition A low-grade malignant neoplasm composed of epithelial cells and a spindle cell osteo-fibrous proliferation. A malignant neoplasm arising from glandular cells that includes focal or extensive areas of squamous metaplasia.

NCI Preferred Term Adamantinoma

C4200

Adenocarcinoma with Squamous Metaplasia Clear Cell Adenocarcinoma

C3766

ADENOCARCINOMA, CLEAR CELL A malignant neoplasm comprising glandular epithelial CLEAR CELL, MALIGNANT CARCINOMA; clear cells. MESONEPHROI D CLEAR CELL ADENOCARCIN OMA; MESONEPHROI D CLEAR CELL CARCINOMA ADENOCARCINOMA, ENDOMETRIAL, MALIGNANT ADENOCARCIN A malignant glandular neoplasm of the uterine lining. OMA OF ENDOMETRIU M; ADENOCARCIN OMA OF THE ENDOMETRIU M A malignant neoplasm arising from glandular cells. GELATINOUS An adenocarcinoma comprising neoplastic glandular ADENOCARCIN cells containing intracytoplasmic mucin. OMA; MUCOID ADENOCARCIN OMA; MUCINOUS CARCINOMA; MUCOUS; ADENOCARCIN OMA; COLLOID ADENOCARCIN OMA; COLLOID CARCINOMA; MUCOID CARCINOMA; MUCOUS CARCINOMA; GELATINOUS CARCINOMA An adenocarcinoma with papillary growth pattern.

C7359

Endometrial Adenocarcinoma

C2852 C26712

ADENOCARCINOMA, MALIGNANT ADENOCARCINOMA, MUCINOUS, MALIGNANT

Adenocarcinoma Mucinous Adenocarcinoma

C2853

ADENOCARCINOMA, PAPILLARY, MALIGNANT

Papillary Adenocarcinoma

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CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym CARCINOMA OF SEBACEOUS GLAND; CARCINOMA OF THE SEBACEOUS GLAND; SEBACEOUS GLAND CARCINOMA BENIGN MIXED MUELLERIAN TUMOR

NCI Code C40310

CDISC Submission Value ADENOCARCINOMA, SEBACEOUS, MALIGNANT

CDISC Definition An adenocarcinoma with sebaceous differentiation.

NCI Preferred Term Sebaceous Carcinoma

C8984

ADENOFIBROMA, BENIGN

Benign mixed neoplasm comprised of epithelial/glandular and mesenchymal structures.

Adenofibroma

C4159 C4196

ADENOLIPOMA, BENIGN ADENOMA, ACINAR CELL, BENIGN ACINIC CELL ADENOMA; ACINAR ADENOMA ADENOMA OF ADNEXA; ADENOMA OF SKIN APPENDAGE; ADNEXAL ADENOMA

Benign mixed neoplasm comprised of epithelial/glandular and lipomatous structures. A benign glandular epithelial neoplasm comprising secretory cells forming acinar patterns.

Lipoadenoma Acinar Cell Adenoma

C7580

ADENOMA, ADNEXAL, BENIGN

A benign glandular epithelial neoplasm comprising secretory cells forming acinar patterns.

Skin Appendage Adenoma

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CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C9003

CDISC Submission Value ADENOMA, ADRENOCORTICAL , BENIGN

CDISC Definition

NCI Preferred Term Adrenal Cortex Adenoma

CORTICAL A benign neoplasm arising from any of the adrenal CELL cortical layers. ADENOMA; ADRENAL CORTICAL ADENOMA; ADRENOCORTI CAL ADENOMA; BENIGN ADRENAL ADENOMA; BENIGN ADENOMA OF THE ADRENAL GLAND; ADENOMA OF THE ADRENAL GLAND; ADRENAL ADENOMA; ADENOMA OF ADRENAL GLAND; ADENOMA OF THE ADRENAL CORTEX; BENIGN ADRENAL GLAND ADENOMA; BENIGN ADENOMA OF ADRENAL GLAND; ADENOMA OF ADRENAL CORTEX; ADRENAL GLAND ADENOMA ADENOMA OF A benign neoplasm of the anterior lobe of the pituitary PITUITARY gland. GLAND; ADENOMA OF PITUITARY; ADENOMA OF THE PITUITARY GLAND; ADENOMA OF THE PITUITARY; PITUITARY ADENOMA

C3329

ADENOMA, ANTERIOR LOBE PITUITARY GLAND, BENIGN

Pituitary Gland Adenoma

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CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C5950

CDISC Submission Value ADENOMA, BASAL CELL, BENIGN

CDISC Definition

NCI Preferred Term Salivary Gland Basal Cell Adenoma

BASAL CELL A benign epithelial neoplasm characterized by the ADENOMA OF presence of/arising from basal cells. SALIVARY GLAND; BASAL CELL ADENOMA OF THE SALIVARY GLAND; BASAL CELL ADENOMA; BENIGN BASAL CELL TUMOR A benign neoplasm arising from epithelium. A benign neoplasia of the lung, arising from bronchial epithelium. ADENOMA OF THE ALVEOLI; ADENOMA OF ALVEOLI PARAFOLLICU LAR CELL ADENOMA CERUMINOUS ADENOMA; CERUMINOUS ADENOMA OF EXTERNAL AUDITORY CANAL; CERUMINOUS ADENOMA OF THE EXTERNAL AUDITORY CANAL; CERUMINOMA A benign lung neoplasm arising from the alveolar/bronchiolar epithelium.

C2855 C3494 C4140

ADENOMA, BENIGN ADENOMA, BRONCHIAL, BENIGN ADENOMA, BRONCHIOLOALVEOLAR, BENIGN ADENOMA, C-CELL, BENIGN ADENOMA, CERUMINOUS GLAND, BENIGN

Adenoma Lung Papillary Adenoma Alveolar Adenoma

C46101

A benign neoplasm arising from C-cells of the thyroid gland. A benign epithelial neoplasm derived from ceruminous glands in the external auditory canal.

Neoplastic C-Cell Hyperplasia

C6088

External Auditory Canal Ceruminous Adenoma

C4151

ADENOMA, CLEAR CELL, BENIGN

A benign neoplasm comprising glands containing epithelial clear cells.

Clear Cell Adenoma

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C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym ADENOMA OF THE THYROID GLAND; THYROID ADENOMA; FOLLICULAR ADENOMA OF THE THYROID; THYROID FOLLICULAR ADENOMA; ADENOMA OF THYROID; ADENOMA OF THYROID GLAND; FOLLICULAR ADENOMA OF THE THYROID GLAND; FOLLICULAR ADENOMA OF THYROID GLAND; ADENOMA OF THE THYROID; FOLLICULAR ADENOMA OF THYROID; THYROID GLAND ADENOMA; FOLLICULAR ADENOMA ADENOMA OF THE LIVER CELLS; LIVER CELL ADENOMA; HCA; ADENOMA OF LIVER CELLS

NCI Code C3502

CDISC Submission Value ADENOMA, FOLLICULAR CELL, BENIGN

CDISC Definition A benign neoplasm arising from follicular cells of the thyroid gland.

NCI Preferred Term Thyroid Gland Follicular Adenoma

C3758

ADENOMA, HEPATOCELLULAR, BENIGN

A benign epithelial neoplasm arising from hepatocytes.

Hepatocellular Adenoma

C7126

ADENOMA, HEPATOCHOLANGIOCELL ULAR, BENIGN ADENOMA, ISLET CELL, BENIGN ADENOMA, LIGHT CELL, BENIGN ADENOMA, MUCINOUS, BENIGN PSEUDOMUCI NOUS CYSTADENOM A; MUCINOUS CYSTOMA; MUCINOUS ADENOMA ISLET CELL ADENOMA

A benign neoplasm arising from the intrahepatic bile duct. A benign neoplasm arising from the islet cells of the pancreas. A benign epithelial neoplasm of the thyroid gland comprising follicular cells with cytoplasmic clearing. A benign, cystic epithelial neoplasm comprising cells containing intracytoplasmic mucin.

Intrahepatic Bile Duct Adenoma

C65184 C46119 C2973

Islet Cell Adenoma Thyroid Gland Clear Cell Follicular Adenoma Mucinous Cystadenoma

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C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C79951 C60490 C60493

CDISC Submission Value ADENOMA, PAPILLARY, BENIGN ADENOMA, PARS DISTALIS, BENIGN ADENOMA, PARS INTERMEDIA, BENIGN ADENOMA, PITUITARY GLAND, BENIGN ADENOMA, RENAL CELL, BENIGN ADENOMA, RETE TESTIS, BENIGN ADENOMA, SEBACEOUS, BENIGN

CDISC Definition A benign epithelial neoplasm characterized by the presence of papillary epithelial patterns.

NCI Preferred Term Papillary Adenoma Rat Pars Distalis Adenoma Rat Pars Intermedia Adenoma

Rat Pars Distalis Adenoma Rat Pars Intermedia Adenoma

A benign epithelial neoplasm arising from the pars distalis of the anterior pituitary gland. A benign epithelial neoplasm arising from the pars intermedia of the anterior pituitary gland. A benign neoplasm of the pituitary gland.

C98723 C8383

Experimental Organism Pituitary Gland Adenoma Renal Adenoma

RENAL TUBULE ADENOMA

A benign neoplasm arising from the renal cortex.

C39956 C4174

A benign epithelial neoplasm arising from the rete testis. SEBACEOUS GLAND ADENOMA; ADENOMA OF THE SEBACEOUS GLAND; ADENOMA OF SEBACEOUS GLAND; SKIN APPENDAGE SEBACEOUS ADENOMA A benign neoplasm arising from sebaceous glands.

Rete Testis Adenoma Sebaceous Adenoma

C92180 C7560

ADENOMA, SERTOLIFORM TUBULAR, BENIGN ADENOMA, SWEAT GLAND, BENIGN

Rat Sertoliform A benign tubular adenoma with Sertoli cell Tubular Adenoma differentiation. ADENOMA OF A benign epithelias neoplasm arising from sweat THE SWEAT glands. GLAND; ADENOMA OF SWEAT GLAND A benign neoplasm arising from glandular epithelium, characterized by a tubular architectural pattern. A benign ovarian epithelial neoplasm characterized by the presence of tubular structures and interstitial stroma. A benign epithelial neoplasm arising from the yolk sac. A benign neoplasm of the rodent Zymbal's gland with sebaceous and/or squamous differentiation. A benign neoplasm characterized by the presence of a glandular and a mesenchymal component. SUBCAPSULAR A benign neoplasm located beneath the adrenal SINGLE CELL capsule. ADENOMA, ADRENAL

Rat Sertoliform Tubular Adenoma Sweat Gland Adenoma

C4133 C79953

ADENOMA, TUBULAR CELL, BENIGN ADENOMA, TUBULOSTROMAL, BENIGN ADENOMA, YOLK SAC, BENIGN ADENOMA, ZYMBAL'S GLAND ADENOMYOMA, BENIGN ADRENAL TUMOR, SUBCAPSULAR, BENIGN

Tubular Adenoma Tubulostromal Adenoma

C84357 C98800 C3726 C83488

Yolk Sac Adenoma Zymbal's Gland Adenoma Adenomyoma Benign Subcapsular Adrenal Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 320 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C83489

CDISC Submission Value ADRENAL TUMOR, SUBCAPSULAR, MALIGNANT ADRENAL TUMOR, SUBCAPSULAR, UNDETERMINED

CDISC Definition

NCI Preferred Term Malignant Subcapsular Adrenal Tumor

SUBCAPSULAR A malignant neoplasm located beneath the adrenal SINGLE CELL capsule. CARCINOMA, ADRENAL SUBCAPSULAR A neoplasm located beneath the adrenal capsule in CELL TUMOR, which the malignancy status has not been established. ADRENAL; SUBCAPSULAR CELL TUMOR, ADRENAL ADRENAL A neoplasm of the adrenal cortex in which the CORTEX malignancy status has not been established. TUMOR; ADRENOCORTI CAL NEOPLASM; ADRENOCORTI CAL TUMOR A benign odontogenic neoplasm arising from the epithelial component of the embryonic tooth. MALIGNANT AMELOBLAST OMA A malignant odontogenic neoplasm arising from the epithelial component of the embryonic tooth. A odontogenic neoplasm arising from the epithelial component of the embryonic tooth of undetermined malignancy status. FIBROANGIOM A benign, morphologic variant of fibroma A, BENIGN; characterized by the presence of numerous dilated FIBROUS vascular channels. PAPULE; TELANGIECTAT IC FIBROMA; ANGIOFIBROM ATOUS HYPERPLASIA ANGIOLIPOMA A lipoma characterized by prominent vascularization. A malignant neoplasm of the brain or spinal cord originating from astrocytes, exhibiting poor differentiation (anaplasia).

C82973

Subcapsular Adrenal Tumor

C2858

ADRENOCORTICAL NEOPLASM, UNDETERMINED

Adrenal Cortex Neoplasm

C7111 C54297

AMELOBLASTOMA, BENIGN AMELOBLASTOMA, MALIGNANT AMELOBLASTOMA, UNDETERMINED ANGIOFIBROMA, BENIGN

Benign Ameloblastoma Metastasizing Ameloblastoma

C4313

Ameloblastoma

C3799

Angiofibroma

C3733 C9477

ANGIOLIPOMA, BENIGN

Angiolipoma Anaplastic Astrocytoma

ASTROCYTOMA, GRADE III ANAPLASTIC , MALIGNANT ASTROCYTIC TUMOR; GRADE III ASTROCYTOM A; GRADE III ASTROCYTIC NEOPLASM; MALIGNANT ASTROCYTOM A

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CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym GRADE I ASTROCYTIC NEOPLASM; GRADE I ASTROCYTOM A; GRADE I ASTROCYTIC TUMOR ASTROCYTOM A, DIFFUSE

NCI Code C4047

CDISC Submission Value ASTROCYTOMA, PILOCYTIC, BENIGN

CDISC Definition A benign neoplasm of the brain or spinal cord arising from astrocytes associated with single or multiple cysts.

NCI Preferred Term Pilocytic Astrocytoma

C60781

ASTROCYTOMA, UNDETERMINED BASOSQUAMOUS TUMOR, BENIGN

A neoplasm of the brain or spinal cord exhibiting astrocytic differentiation, but in which the malignancy status has not been established.

Astrocytoma

C4614

CUTANEOUS A benign papillary neoplasm of the skin. PAPILLOMA; PAPILLOMA OF SKIN; PAPILLOMA OF THE SKIN BASOSQUAMO US CARCINOMA; SKIN MIXED BASAL AND SQUAMOUS CELL CARCINOMA; BASOSQUAMO US CELL CARCINOMA MALIGNANT CARCINOID TUMOR CARCINOID; WELL-DIFFERE NTIATED ENDOCRINE NEOPLASM; CARCINOID NEOPLASM A basal cell carcinoma (skin neoplasm) which displays squamous differentiation.

Skin Papilloma

C2922

BASOSQUAMOUS TUMOR, MALIGNANT

Skin Basosquamous Cell Carcinoma

C72074

CARCINOID TUMOR, ATYPICAL, MALIGNANT CARCINOID TUMOR, UNDETERMINED

A malignant neuroendocrine neoplasm arising from enterochromaffin cells in the gastrointestinal tract and (less common) in the bronchi exhibiting atypia. A neuroendocrine neoplasm arising from enterochromaffin cells in the gastrointestinal tract and (less common) the bronchi with undetermined malignancy status.

Atypical Carcinoid Tumor

C2915

Carcinoid Tumor

C4147

CARCINOMA, ACIDOPHIL, MALIGNANT

EOSINOPHIL A malignant epithelial neoplasm of the anterior CARCINOMA; pituitary gland in which the neoplastic cells stain ACIDOPHIL positive with acidic dyes. ADENOCARCIN OMA; ACIDOPHIL CARCINOMA; EOSINOPHIL ADENOMCARC INOMA

Pituitary Gland Acidophil Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 322 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3768

CDISC Submission Value CARCINOMA, ACINAR CELL, MALIGNANT

CDISC Definition

NCI Preferred Term Acinar Cell Carcinoma

ACINAR A malignant glandular epithelial neoplasm comprising ADENOCARCIN secretory cells forming acinar patterns. OMA; ACINIC CELL ADENOCARCIN OMA; ACINAR CARCINOMA; ACINAR CELL ADENOCARCIN OMA; ACINIC CELL CARCINOMA MIXED An epithelial neoplasm composed of malignant ADENOCARCIN glandular and malignant squamous cells. OMA AND SQUAMOUS CARCINOMA; MIXED ADENOCARCIN OMA AND EPIDERMOID CELL CARCINOMA; MIXED ADENOCARCIN OMA AND SQUAMOUS CELL CARCINOMA; MIXED ADENOCARCIN OMA AND EPIDERMOID CARCINOMA SKIN APPENDAGE CARCINOMA; CARCINOMA OF ADNEXA; CARCINOMA OF SKIN APPENDAGE A malignant epithelial neoplasm arising from sebaceous or sweat glands or from hair follicles.

C3727

CARCINOMA, ADENOSQUAMOUS, MALIGNANT

Adenosquamous Carcinoma

C3775

CARCINOMA, ADNEXAL, MALIGNANT

Adnexal Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 323 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C9325

CDISC Submission Value CARCINOMA, ADRENOCORTICAL, MALIGNANT

CDISC Definition

NCI Preferred Term Adrenal Cortex Carcinoma

CORTICAL A malignant epithelial neoplasm arising from adrenal CELL cortical cells. CARCINOMA; ADENOCARCIN OMA, ADRENOCORTI CAL, MALIGNANT; ADRENAL CORTEX ADENOCARCIN OMA; ADRENAL CORTEX CANCER; ADRENAL CORTICAL ADENOCARCIN OMA; ADRENAL CORTICAL CARCINOMA; ADRENOCORTI CAL CARCINOMA A malignant epithelial neoplasm arising from basal cells of the epidermis and pilosebaceous unit of skin [the dermis].

C2921

CARCINOMA, BASAL CELL, BASAL CELL MALIGNANT EPITHELIOMA; BASAL CELL CANCER; BASAL CELL CARCINOMA OF SKIN; BASAL CELL CARCINOMA OF THE SKIN; BASAL CELL CARCINOMA; BASAL CELL EPITHELIOMA; BASAL CELL SKIN CARCINOMA; BASILOMA; BCC; RODENT ULCER CARCINOMA, BRONCHIAL, MALIGNANT

Skin Basal Cell Carcinoma

C35875

A malignant neoplasia of the lung, arising from bronchial epithelium.

Bronchogenic Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 324 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C2923

CDISC Submission Value CARCINOMA, BRONCHIOLOALVEOLAR, MALIGNANT

CDISC Definition

NCI Preferred Term Bronchioloalveolar Carcinoma

BRONCHIOALV A malignant lung neoplasm originating from the EOLAR alveolar/bronchiolar epithelium. ADENOCARCIN OMA OF LUNG; BRONCHIOLOALVEOLAR LUNG CARCINOMA; BRONCHIOLOA LVEOLAR ADENOCARCIN OMA OF LUNG; BRONCHIOLOA LVEOLAR LUNG ADENOCARCIN OMA; BAC; BRONCHIOLOALVEOLAR CARCINOMA OF LUNG; BRONCHIOLOALVEOLAR CARCINOMA OF THE LUNG; BRONCHIOALV EOLAR LUNG CARCINOMA; BRONCHIOLOA LVEOLAR ADENOCARCIN OMA OF THE LUNG; BRONCHIOALV EOLAR ADENOCARCIN OMA OF THE LUNG

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 325 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3879

CDISC Submission Value CARCINOMA, C-CELL, MALIGNANT

CDISC Definition

NCI Preferred Term Thyroid Gland Medullary Carcinoma

PARAFOLLICU A neuroendocrine malignant epithelial neoplasm LAR CELL arising from C-cells of the thyroid gland. CARCINOMA; C CELL CARCINOMA; MEDULLARY CARCINOMA OF THYROID GLAND; THYROID GLAND NEUROENDOC RINE CARCINOMA; MEDULLARY CARCINOMA OF THE THYROID GLAND; MEDULLARY THYROID CANCER; PARAFOLLICU LAR CELL CARCINOMA; MEDULLARY THYROID CARCINOMA; MEDULLARY CARCINOMA OF THYROID; MEDULLARY CARCINOMA; MTC; MEDULLARY CARCINOMA OF THE THYROID; MEDULLARY THYROID GLAND CARCINOMA; THYROID MEDULLARY CARCINOMA A malignant neoplasm derived from ceruminous glands in the external auditory canal.

C4176

CARCINOMA, CERUMINOUS GLAND, MALIGNANT

Ceruminous Adenocarcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 326 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym CHOROID PLEXUS CANCER; CARCINOMA OF THE CHOROID PLEXUS; CARCINOMA OF CHOROID PLEXUS; CANCER OF THE CHOROID PLEXUS; CANCER OF CHOROID PLEXUS; ANAPLASTIC CHOROID PLEXUS PAPILLOMA

NCI Code C4715

CDISC Submission Value CARCINOMA, CHOROID PLEXUS, MALIGNANT

CDISC Definition A malignant neoplasm arising from the choroid plexus of the brain.

NCI Preferred Term Choroid Plexus Carcinoma

C3752

CARCINOMA, CARCINOMA, EMBRYONAL, MALIGNANT EMBRYONAL, MALIGNANT CARCINOMA, ENDOMETRIAL, MALIGNANT CARCINOMA OF ENDOMETRIU M; CARCINOMA OF THE ENDOMETRIU M

A non-seminomatous malignant germ cell neoplasm of the testis or ovary. A malignant epithelial neoplasm arising from the lining of the uterine body cavity.

Embryonal Carcinoma

C7558

Endometrial Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 327 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C8054

CDISC Submission Value

CDISC Definition

NCI Preferred Term Thyroid Gland Follicular Carcinoma

CARCINOMA, FOLLICULAR FOLLICULAR A malignant neoplasia arising from follicular cells of CELL, MALIGNANT THYROID the thyroid gland. CANCER; WELL-DIFFERE NTIATED FOLLICULAR CARCINOMA; FOLLICULAR ADENOCARCIN OMA; FOLLICULAR CANCER OF THE THYROID; FOLLICULAR CARCINOMA OF THE THYROID GLAND; WELL-DIFFERE NTIATED FOLLICULAR ADENOCARCIN OMA; FOLLICULAR CARCINOMA; FOLLICULAR CARCINOMA OF THYROID GLAND; FOLLICULAR CANCER OF THYROID; FOLLICULAR THYROID CARCINOMA; THYROID FOLLICULAR CARCINOMA; FOLLICULAR CARCINOMA OF THE THYROID; FOLLICULAR CANCER OF THYROID GLAND; FOLLICULAR CANCER OF THE THYROID GLAND; FOLLICULAR CARCINOMA OF THYROID; FOLLICULAR THYROID GLAND CARCINOMA

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 328 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym CARCINOMA OF LIVER CELLS; PRIMARY CARCINOMA OF THE LIVER CELLS; LIVER CELL CARCINOMA; HEPATOMA; CARCINOMA OF THE LIVER CELLS; PRIMARY CARCINOMA OF LIVER CELLS; HCC

NCI Code C3099

CDISC Submission Value CARCINOMA, HEPATOCELLULAR, MALIGNANT

CDISC Definition A malignant neoplasm arising from hepatocytes.

NCI Preferred Term Hepatocellular Carcinoma

C3828

CARCINOMA, HEPATOCHOLANGIOCELL ULAR, MALIGNANT CARCINOMA, IN SITU, MALIGNANT

A malignant neoplasm of the liver containing unequivocal elements of both hepatocellular and cholangiocarcinoma intimately admixed. EPITHELIAL A malignant epithelial neoplasm confined to the TUMOR, IN epithelial layer and without evidence of further tissue SITU, invasion. MALIGNANT; INTRAEPITHELI AL CARCINOMA; NON-INVASIVE CARCINOMA; CIS PANCREATIC NEUROENDOC RINE CARCINOMA; MALIGNANT PANCREATIC ENDOCRINE TUMOR; MALIGNANT ISLET CELL TUMOR; ISLET CELL CANCER; ISLET CELL CARCINOMA A malignant endocrine neoplasm arising from islets of Langerhans of the pancreas.

Combined Hepatocellular Carcinoma and Cholangiocarcinoma Carcinoma In Situ

C2917

C3770

CARCINOMA, ISLET CELL, MALIGNANT

Pancreatic Neuroendocrine Carcinoma

C2916

CARCINOMA, MALIGNANT EPITHELIOMA MALIGNANT; EPITHELIAL CARCINOMA; MALIGNANT EPITHELIAL NEOPLASM; MALIGNANT EPITHELIAL TUMOR; MALIGNANT EPITHELIOMA

A malignant epithelial neoplasm.

Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 329 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C6878

CDISC Submission Value CARCINOMA, MIXED, ACINAR-ISLET CELL, MALIGNANT CARCINOMA, NEUROENDOCRINE CELL, MALIGNANT

CDISC Definition A malignant pancreatic neoplasm characterized by the presence of a mixture of acinar and islet cell elements.

NCI Preferred Term Mixed Acinar-Neuroendocrine Carcinoma of the Pancreas Neuroendocrine Carcinoma

C3773

NEURAL A malignant neuroendocrine neoplasm comprising CREST TUMOR, cells containing secretory granules. MALIGNANT; NEUROENDOC RINE TUMOR, MALIGNANT; NEUROENDOC RINE CELL CARCINOMA; NEUROENDOC RINE CARCINOMA Rat Pars Distalis Carcinoma A malignant epithelial neoplasm arising from the pars distalis of the pituitary gland. A malignant epithelial neoplasm arising from the pars intermedia of the pituitary gland.

C60491 C92183

CARCINOMA, PARS DISTALIS, MALIGNANT

Rat Pars Distalis Carcinoma Rat Pars Intermedia Carcinoma

CARCINOMA, PARS Rat Pars INTERMEDIA, MALIGNANT Intermedia Carcinoma CARCINOMA, RENAL CELL, MALIGNANT

C9385

ADENOCARCIN A malignant neoplasm arising from renal parenchyma. OMA OF THE KIDNEY; RENAL CELL CANCER; KIDNEY ADENOCARCIN OMA; RCC; RENAL CELL CARCINOMA, STAGE UNSPECIFIED; RENAL CELL ADENOCARCIN OMA; ADENOCARCIN OMA OF KIDNEY RENAL TUBULE CARCINOMA; MUCINOUS TUBULAR AND SPINDLE CELL CARCINOMA OF THE KIDNEY A malignant neoplasm of the kidney, characterized by the presence of tubules.

Renal Cell Carcinoma

C39807

CARCINOMA, RENAL, TUBULAR, MALIGNANT

Mucinous Tubular and Spindle Cell Carcinoma of the Kidney

C27004

CARCINOMA, SPINDLE CELL, MALIGNANT

PSEUDOSARCO A malignant epithelial neoplasm characterized by the MATOUS presence of spindle cells. CARCINOMA; SPINDLE CELL CARCINOMA

Sarcomatoid Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 330 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C27093

CDISC Submission Value CARCINOMA, SQUAMOUS CELL, IN SITU, MALIGNANT

CDISC Definition

NCI Preferred Term Stage 0 Squamous Cell Carcinoma

EPIDERMOID A malignant epithelial neoplasm confined to the CELL squamous epithelium, without invasion of underlying CARCINOMA tissues. IN SITU; EPIDERMOID CARCINOMA IN SITU; GRADE III SQUAMOUS INTRAEPITHELI AL NEOPLASIA; INTRAEPITHELI AL SQUAMOUS CELL CARCINOMA; SQUAMOUS CELL CARCINOMA IN SITU; GRADE 3 SQUAMOUS INTRAEPITHELI AL NEOPLASIA; SQUAMOUS CARCINOMA IN SITU MALIGNANT EPIDERMOID CELL NEOPLASM; SQUAMOUS CARCINOMA; EPIDERMOID CARCINOMA; MALIGNANT SQUAMOUS CELL TUMOR; SQUAMOUS CELL EPITHELIOMA; EPIDERMOID CELL CANCER; MALIGNANT SQUAMOUS CELL NEOPLASM; MALIGNANT EPIDERMOID CELL TUMOR; SQUAMOUS CELL CANCER A malignant neoplasm arising from squamous epithelial cells.

C2929

CARCINOMA, SQUAMOUS CELL, MALIGNANT

Squamous Cell Carcinoma

C6938

CARCINOMA, SWEAT GLAND, MALIGNANT

CARCINOMA A malignant neoplasm arising from sweat glands. OF SWEAT GLAND; CARCINOMA OF THE SWEAT GLAND

Sweat Gland Carcinoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 331 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C2930

CDISC Submission Value CARCINOMA, TRANSITIONAL CELL, MALIGNANT CARCINOMA, TUBULAR CELL, MALIGNANT CARCINOMA, TUBULOSTROMAL, MALIGNANT CARCINOMA, UNDIFFERENTIATED, MALIGNANT

CDISC Definition

NCI Preferred Term Transitional Cell Carcinoma

TRANSITIONAL A malignant neoplasm arising from transitional CARCINOMA epithelium, usually affecting the urinary bladder, ureter, or renal pelvis. A malignant glandular neoplasm exhibiting tubular structures. A malignant epithelial neoplasm of the ovary with tubular and stromal neoplastic components. ANAPLASTIC A malignant epithelial neoplasm exhibiting poor CARCINOMA; differentiation (anaplasia). CARCINOMA, UNDIFFERENTI ATED A malignant neoplasm of the rodent Zymbal's gland with sebaceous and/or squamous differentiation. A malignant neoplasm comprising a mixture of carcinomatous and sarcomatous elements. SCHWANNOM A benign peripheral nervous system neoplasm that is A, composed of well-differentiated Schwann cells and ENDOCARDIAL affects the heart. , BENIGN BENIGN CHEMODECTO MA A benign neoplasm of the chemoreceptor system (e.g. carotid body, glomus jugulare, glomus vagale).

C65192 C80356

Tubular Adenocarcinoma Tubulostromal Adenocarcinoma

C3692

Undifferentiated Carcinoma

C98801 C34448 C5358

CARCINOMA, ZYMBAL'S GLAND CARCINOSARCOMA, MALIGNANT CARDIAC SCHWANNOMA, BENIGN

Zymbal's Gland Carcinoma Carcinosarcoma Benign Cardiac Schwannoma

C79950

CHEMODECTOMA, BENIGN CHEMODECTOMA, MALIGNANT

Benign Carotid Body Paraganglioma

C3574

MALIGNANT A malignant neoplasm of the chemoreceptor system TUMOR OF THE (e.g. carotid body, glomus jugulare, glomus vagale). CAROTID BODY; MALIGNANT CAROTID BODY TUMOR; MALIGNANT NEOPLASM OF THE CAROTID BODY; MALIGNANT NEOPLASM OF CAROTID BODY; MALIGNANT CAROTID BODY NEOPLASM; MALIGNANT TUMOR OF CAROTID BODY

Malignant Carotid Body Paraganglioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 332 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C2932

CDISC Submission Value CHEMODECTOMA, UNDETERMINED

CDISC Definition

NCI Preferred Term Carotid Body Paraganglioma

PARAGANGLIO A neoplasm of the chemoreceptor system (e.g. carotid MA OF body, glomus jugulare, glomus vagale) for which the CAROTID malignancy status has not be established. BODY; CHEMODECTO MA; PARAGANGLIO MA OF THE CAROTID BODY; TUMOR OF THE CAROTID BODY; CAROTID BODY TUMOR; CAROTID BODY CHEMODECTO MA; TUMOR OF CAROTID BODY PERIPHERAL A malignant neoplasm of the liver arising CHOLANGIOCA from/comprising cells resembling those of bile ducts. RCINOMA; INTRAHEPATIC CARCINOMA OF BILE DUCT; INTRAHEPATIC CARCINOMA OF THE BILE DUCT; INTRAHEPATIC BILE DUCT CARCINOMA; HEPATOCHOL ANGIOCELLUL AR CARCINOMA CHOLANGIOCE A malignant neoplasm arising from/comprising cells LLULAR resembling those of bile ducts. CARCINOMA HEPATOCHOL ANGIOMA; CHOLANGIOM A; ADENOMA OF BILE DUCT; ADENOMA OF THE BILE DUCT; CHOLANGIOA DENOMA; CHOLANGIOFI BROMA; HEPATOCHOL ANGIOCELLUL AR ADENOMA A benign neoplasm arising from/comprising cells resembling those of bile ducts.

C35417

CHOLANGIOCARCINOMA, INTRAHEPATIC, MALIGNANT

Intrahepatic Cholangiocarcinoma

C4436

CHOLANGIOCARCINOMA, MALIGNANT CHOLANGIOMA, BENIGN

Cholangiocarcinoma

C2942

Bile Duct Adenoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 333 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C53459

CDISC Submission Value CHONDROMA, BENIGN

CDISC Definition A benign, well circumscribed neoplasm arising from the hyaline cartilage in soft tissue or bone. It is characterized by the presence of chondrocytes. A malignant mesenchymal neoplasm arising from cartilage-forming tissues. A malignant bone neoplasm arising from the remnants of the fetal notochord.

NCI Preferred Term Chondroma

C2946 C2947 C2948

CHONDROSARCOMA, MALIGNANT CHORDOMA, MALIGNANT CHORIOCARCINOMA, MALIGNANT

Chondrosarcoma Chordoma Choriocarcinoma

CHORIOEPITHE A malignant neoplasm arising from placental LIOMA; trophoblast cells. They generally arise in the uterus. CHORIOEPITHE LIOMA NEOPLASM OF RATHKE'S POUCH; TUMOR OF RATHKE'S POUCH; RATHKE POUCH TUMOR; RATHKE POUCH NEOPLASM; RATHKE'S POUCH TUMOR; RATHKE'S POUCH NEOPLASM; CYSTOMA A benign epithelial neoplasm of the sellar region, presumably derived from Rathke pouch epithelium.

C2964

CRANIOPHARYNGIOMA, BENIGN

Craniopharyngioma

C79949

CRANIOPHARYNGIOMA, MALIGNANT

CARCINOMA A malignant epithelial neoplasm of the sellar region, ARISING FROM presumably derived from Rathke pouch epithelium. CRANIOPHARY NGIOMA A malignant cystic epithelial neoplasm arising from glandular epithelium. A malignant cystic epithelial neoplasm arising from glandular epithelium exhibiting papillary structures. CYSTOMA A benign cystic epithelial neoplasm arising from glandular epithelium. A benign cystic epithelial neoplasm arising from glandular epithelium exhibiting papillary structures.

Carcinoma Arising from Craniopharyngioma

C2971 C3777 C2972 C2974

CYSTADENOCARCINOMA, MALIGNANT CYSTADENOCARCINOMA, PAPILLARY, MALIGNANT CYSTADENOMA, BENIGN CYSTADENOMA, PAPILLARY, BENIGN

Cystadenocarcinoma Papillary Cystadenocarcinoma Cystadenoma Papillary Cystadenoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 334 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3555

CDISC Submission Value

CDISC Definition

NCI Preferred Term Malignant Placental Neoplasm

DECIDUOMA, MALIGNANT MALIGNANT A malignant neoplasm arising from decidua (placental) PLACENTAL cells. TUMOR; MALIGNANT PLACENTAL NEOPLASM; MALIGNANT NEOPLASM OF PLACENTA; MALIGNANT TUMOR OF THE PLACENTA; MALIGNANT NEOPLASM OF THE PLACENTA; MALIGNANT TUMOR OF PLACENTA; MALIGNANT PLACENTAL TUMOR DECIDUOMA, UNDETERMINED DECIDUOMA A neoplasm arising from decidua (placental) cells in NOS; which the malignancy status has not been established. PLACENTA NEOPLASMS; PLACENTA TUMORS; PLACENTA TUMOR; TUMOR OF PLACENTA; TUMOR OF THE PLACENTA; PLACENTAL TUMORS; PLACENTAL TUMOR; NEOPLASM OF THE PLACENTA; PLACENTA NEOPLASM; NEOPLASM OF PLACENTA BENIGN CYSTIC TERATOMA; DERMOID; MATURE CYSTIC TERATOMA A benign neoplasm comprised of a cyst, lined by mature epidermis-like tissue with dermal appendages.

C4858

Placental Neoplasm

C9011

DERMOID CYST, BENIGN

Dermoid Cyst

C2996

DYSGERMINOMA, MALIGNANT

A malignant germ cell neoplasm characterized by the presence of a monotonous primitive germ cell population, primarily in the ovary.

Dysgerminoma

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CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4049

CDISC Submission Value

CDISC Definition

NCI Preferred Term Anaplastic Ependymoma

EPENDYMOMA, WHO GRADE III A malignant neoplasm of ependymal origin with ANAPLASTIC , MALIGNANT EPENDYMAL anaplastic cellular morphology. TUMOR; UNDIFFERENTI ATED EPENDYMAL NEOPLASM; MALIGNANT EPENDYMOMA ; UNDIFFERENTI ATED EPENDYMAL TUMOR; UNDIFFERENTI ATED EPENDYMOMA ; ANAPLASTIC EPENDYMAL NEOPLASM; ANAPLASTIC EPENDYMAL TUMOR; WHO GRADE III EPENDYMAL NEOPLASM EPENDYMOMA, UNDETERMINED WHO GRADE II EPENDYMAL TUMOR; WHO GRADE II EPENDYMAL NEOPLASM A neoplasm of ependymal origin, for which the malignancy status has not been established.

C3017

Ependymoma

C4092

EPITHELIOMA, BENIGN

BENIGN A benign neoplasm arising from epithelial cells of the EPITHELIAL skin. TUMOR; BENIGN EPITHELIOMA; BENIGN NEOPLASM OF EPITHELIUM; BENIGN TUMOR OF THE EPITHELIUM; BENIGN NEOPLASM OF THE EPITHELIUM; BENIGN TUMOR OF EPITHELIUM A benign cystic epithelial neoplasm featuring a central keratin mass surrounded by squamous epithelium. A benign cystic epithelial neoplasm characterized by the absence of keratin production.

Benign Epithelial Neoplasm

C80349 C84356

EPITHELIOMA, CYSTIC KERATINIZING, BENIGN EPITHELIOMA, NON-KERATINIZING, BENIGN

Cystic Keratinizing Epithelioma Non-Keratinizing Epithelioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 336 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C2928

CDISC Submission Value

CDISC Definition

NCI Preferred Term Scirrhous Adenocarcinoma

FIBROADENOCARCINOMA, ADENOCARCIN A malignant neoplasm originating from glandular cells MALIGNANT OMA WITH with a fibrous or fibroblastic component. PRODUCTIVE FIBROSIS; FIBROCARCIN OMA; SCIRRHOUS CARCINOMA FIBROADENOMA, BENIGN FIBROADENO MA OF BREAST; BREAST FIBROADENO MA; FIBROADENO MA OF THE BREAST A benign neoplasm originating from glandular cells with a fibrous or fibroblastic component.

C3744

Fibroadenoma

C4249 C3041 C4314

FIBROLIPOMA, BENIGN FIBROMA, BENIGN

A benign neoplasm comprising mature adipocytes, characterized by areas of abundant fibrous tissue. A benign neoplasm arising from fibrous tissue.

Fibrolipoma Fibroma Odontogenic Fibroma

FIBROMA, ODONTOGENIC, CENTRAL A benign intraosseous neoplasm arising from BENIGN ODONTOGENIC tooth-forming tissues in the mandible and maxilla, FIBROMA characterized by the presence of islands of odontogenic epithelium. FIBROMA, OSSIFYING, BENIGN OSSIFYING FIBROMA; CEMENTIFYIN G FIBROMA; CEMENTO-OSS IFYING FIBROMA FIBROMYXOM A A benign fibrous neoplasm characterized by a mineralized component (woven bone, lamellar bone, or cementum-like material).

C8422

Ossifying Fibroma

C66760

FIBROMYXOMA, BENIGN

A benign soft-tissue neoplasm of uncertain lineage, characterized by the presence of neoplastic spindle-shaped to round cells and a fibromyxoid stroma. A benign polypoid tumor comprising fibrous tissue and epithelium. A malignant mesenchymal neoplasm of the soft tissue and bone. A neuroepithelial neoplasm comprised of neoplastic ganglion cells and neoplastic glial cells, in which the malignancy status has not been established. A malignant neoplasm characterized by the presence of neuroblastic and ganglion cells and a stroma with Schwannian differentiation. A benign neoplasm characterized by the presence of ganglion cells and spindle cell proliferation, located primarily in the brain, ganglia, or adrenal medulla.

Fibromyxoid Neoplasm

C3337 C3043 C3788

FIBROPAPILLOMA, BENIGN FIBROSARCOMA, MALIGNANT GANGLIOGLIOMA, UNDETERMINED GANGLIONEUROBLASTOM A, MALIGNANT GANGLIONEUROMA, BENIGN

Fibroepithelial Polyp Fibrosarcoma Ganglioglioma

C3790

Ganglioneuroblastoma

C3049

Ganglioneuroma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 337 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym OSTEOCLASTO MA, BENIGN; BENIGN BONE GIANT CELL TUMOR MALIGNANT GIANT CELL TUMOR

NCI Code C27477

CDISC Submission Value GIANT CELL TUMOR, BENIGN

CDISC Definition A benign neoplasm of bone comprised of giant cells (osteoclast-like) and mononuclear cells.

NCI Preferred Term Benign Giant Cell Tumor of Bone

C4090

GIANT CELL TUMOR, MALIGNANT GIANT CELL TUMOR, UNDETERMINED

A malignant neoplasm of bone comprised of giant cells (osteoclast-like) and mononuclear cells.

Malignant Giant Cell Neoplasm

C3055

TUMOR OF A neoplasm of bone comprised of giant cells GIANT CELL; (osteoclast-like) and mononuclear cells, for which the TUMOR OF THE malignancy status has not been established. GIANT CELL MALIGNANT NEUROGLIAL NEOPLASM; MALIGNANT GLIAL NEOPLASM; MALIGNANT NEUROGLIAL TUMOR; MALIGNANT GLIAL TUMOR GLIOMA, MIXED; MIXED NEUROGLIAL TUMOR; MIXED NEUROGLIAL NEOPLASM; MIXED GLIAL TUMOR; MIXED GLIAL NEOPLASM BENIGN GRANULAR CELL TUMOR; BENIGN GRANULAR CELL NEOPLASM; BENIGN GRANULAR CELL MYOBLASTOM A; MYOBLASTOM A A malignant neuroglial neoplasm. The term can apply to several primary neoplasm of the brain and spinal cord, including astrocytoma and oligodendroglioma in addition to others.

Giant Cell Tumor

C4822

GLIOMA, MALIGNANT

Malignant Glioma

C3903

GLIOMA, MIXED, MALIGNANT

A malignant neoplasm comprising two or more glial cell types (e.g., astrocytes, ependymal cells, oligodendrocytes).

Mixed Glioma

C3252

GRANULAR CELL TUMOR, BENIGN

A benign neoplasm, comprised of large cells with cytoplasmatic granules, occurring in various organs/tissues.

Benign Granular Cell Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 338 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym MYOBLASTOM A, MALIGNANT; MALIGNANT GRANULAR CELL NEOPLASM; MALIGNANT GRANULAR CELL MYOBLASTOM A GRANULOSA CELL NEOPLASM GRANULOSA CELL NEOPLASM BENIGN FOLLICULAR NEOPLASM; BENIGN FOLLICULAR TUMOR; BENIGN HAIR FOLLICLE TUMOR MALIGNANT HAIR FOLLICLE TUMOR HAIR FOLLICLE TUMOR; HAIR MATRIX NEOPLASM; HAIR MATRIX TUMOR; NEOPLASM OF HAIR FOLLICLE; NEOPLASM OF THE HAIR FOLLICLE

NCI Code C4336

CDISC Submission Value GRANULAR CELL TUMOR, MALIGNANT

CDISC Definition A malignant neoplasm, comprised of large cells with cytoplasmatic granules, occurring in various organs/tissues.

NCI Preferred Term Malignant Granular Cell Tumor

C4205

GRANULOSA CELL TUMOR, MALIGNANT GRANULOSA CELL TUMOR, UNDETERMINED HAIR FOLLICLE NEOPLASM, BENIGN

A malignant neoplasm of the ovary, originating from granulosa cells. A neoplasm of the ovary (or testis), originating from granulosa cells for which the malignancy status has not been established. A benign neoplasm that arises from the hair follicle.

Malignant Granulosa Cell Tumor

C3070

Granulosa Cell Tumor

C27520

Benign Hair Follicle Neoplasm

C43310

HAIR FOLLICLE NEOPLASM, MALIGNANT

A malignant neoplasm that arises from the hair follicle.

Malignant Hair Follicle Neoplasm

C7367

HAIR FOLLICLE NEOPLASM, UNDETERMINED

A neoplasm that arises from the hair follicle, for which the malignancy status has not been established.

Hair Follicle Neoplasm

C3075

HAMARTOMA, BENIGN

A benign and excessive tumor-like growth of mature cells and normal tissues which grow in a disorganized pattern. A benign hamartomatous tumor composed predominantly of adipose tissue. ANGIOMA; BENIGN ANGIOMA; BENIGN HEMANGIOMA A benign vascular neoplasm characterized by the formation of capillary-sized or cavernous vascular channels.

Hamartoma

C40426 C3085

HAMARTOMA, LIPOMATOUS, BENIGN HEMANGIOMA, BENIGN

Lipomatous Hamartoma Hemangioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 339 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4300 C4301

CDISC Submission Value HEMANGIOPERICYTOMA, BENIGN HEMANGIOPERICYTOMA, MALIGNANT

CDISC Definition A benign neoplasm originating from vascular pericytes (cells in the periphery of vessels).

NCI Preferred Term Benign Hemangiopericytoma Malignant Hemangiopericytoma

MALIGNANT HEMANGIOPE RICYTOMA NOS

A malignant neoplasm originating from vascular pericytes (cells in the periphery of vessels).

C3087

HEMANGIOPERICYTOMA, UNDETERMINED HEMANGIOSARCOMA, MALIGNANT HEPATOBLASTOMA, MALIGNANT HEMANGIOSA RCOMA HBL; PEDIATRIC EMBRYONAL HEPATOMA; PEDIATRIC HEPATOBLAST OMA BROWN FAT NEOPLASM; FETAL FAT CELL LIPOMA; BROWN FAT TUMOR

A neoplasm originating from vascular pericytes (cells in the periphery of vessels), for which the malignancy status has not been established. A malignant vascular neoplasm arising from endothelial cells. A malignant liver neoplasm composed of immature hepatocytic elements.

Hemangiopericytoma

C3088 C3728

Angiosarcoma Hepatoblastoma

C3702

HIBERNOMA, BENIGN

A benign neoplasm of the brown adipose tissue.

Hibernoma

C98708

HISTIOCYTOMA, BENIGN

A benign dermal neoplasm comprising of round cells, resembling histiocytes. The tumor commonly occurs in young dogs and may regress spontaneously. A benign neoplasm composed of a fibroblastic and a histiocytic component.

Benign Histiocytoma

C3739

HISTIOCYTOMA, FIBROUS, FIBROUS BENIGN HISTIOCYTOM A

Benign Fibrous Histiocytoma

C4247

HISTIOCYTOMA, FIBROUS, MALIGNANT A malignant neoplasm composed of a fibroblastic and MALIGNANT FIBROUS a histiocytic component. HISTIOCYTOM A OF THE SOFT TISSUE AND BONE; FIBROXANTHO SARCOMA; MALIGNANT FIBROXANTHO MA; MFH; MALIGNANT FIBROUS HISTIOCYTOM A OF SOFT TISSUE AND BONE HISTIOCYTOMA, FIBROUS, FIBROHISTIOC UNDETERMINED YTIC TUMOR HISTIOCYTOMA, UNDETERMINED A neoplasm composed of a fibroblastic and a histiocytic component, for which the malignancy status has not been established. A neoplasm composed of histiocytic cells, for which the malignancy status has not been established.

Malignant Fibrous Histiocytoma

C8402

Fibrohistiocytic Neoplasm

C35765

Histiocytoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 340 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym BENIGN SPONGIOTIC PERICYTOMA MALIGNANT SPONGIOTIC PERICYTOMA

NCI Code C80351

CDISC Submission Value ITO CELL TUMOR, BENIGN

CDISC Definition A benign neoplasm of the liver composed of hepatic stellate cells (Ito cells). A malignant neoplasm of the liver composed of hepatic stellate cells (Ito cells). An epithelial skin neoplasm, composed of squamous cells, for which the malignancy status has not been established. A benign neoplasm of the gastro-intestinal tract, originating from smooth muscle cells. A malignant neoplasm of the gastro-intestinal tract, originating from smooth muscle cells.

NCI Preferred Term Benign Ito Cell Tumor

C80352

ITO CELL TUMOR, MALIGNANT KERATOACANTHOMA, UNDETERMINED LEIOMYOBLASTOMA, BENIGN LEIOMYOBLASTOMA, MALIGNANT LEIOMYOBLASTOMA, UNDETERMINED

Malignant Ito Cell Tumor

C3146

Keratoacanthoma

C81854 C81855 C3486

Benign Epithelioid Cell Type Gastrointestinal Stromal Tumor Malignant Epithelioid Cell Type Gastrointestinal Stromal Tumor Epithelioid Cell Type Gastrointestinal Stromal Tumor

LEIOMYOBLAS A neoplasm of the gastro-intestinal tract, originating TOMA; from smooth muscle cells, for which the malignancy EPITHELIOID status has not been established. CELL TYPE GIST; STOUT'S LEIOMYOBLAS TOMA LEIOMYOMAT OUS NEOPLASM; LEIOMYOMAT OUS TUMOR; FIBROID NEOPLASM; FIBROID TUMOR; FIBROID A benign neoplasm, originating from smooth muscle cells.

C3157

LEIOMYOMA, BENIGN

Leiomyoma

C3158 C8923

LEIOMYOSARCOMA, MALIGNANT LEUKEMIA, ACUTE ERYTHROID, MALIGNANT

LEIOMYOSARC A malignant neoplasm, originating from smooth OMAS muscle cells. DIGUGLIELMO' A progressive, proliferative disease of blood cells, S DISEASE; originating from immature erythroid cells. DIGUGLIELMO' S SYNDROMA; ERYTHROBLAS TIC LEUKEMIA; ACUTE ERYTHROBLAS TIC LEUKEMIA; DI GUGLIELMO'S DISEASE; M6 ACUTE MYELOID LEUKEMIA; DI GUGLIELMO DISEASE; FAB M6

Leiomyosarcoma Acute Erythroid Leukemia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 341 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3167

CDISC Submission Value LEUKEMIA, ACUTE LYMPHOBLASTIC, MALIGNANT

CDISC Definition

NCI Preferred Term Acute Lymphoblastic Leukemia

LYMPHOBLAS A progressive, proliferative disease of blood cells, TIC LEUKEMIA; originating from immature lymphoid cells. ALL - ACUTE LYMPHOCYTIC LEUKEMIA; ACUTE LYMPHOID LEUKEMIA; PRECURSOR CELL LYMPHOBLAS TIC LEUKEMIA; ALL; PRECURSOR LYMPHOBLASI C LEUKEMIA; ACUTE LYMPHOGENO US LEUKEMIA; ACUTE LYMPHOCYTIC LEUKEMIAS; ACUTE LYMPHOCYTIC LEUKAEMIA ACUTE A progressive, proliferative disease of blood cells, MEGAKARYOC originating from immature megakaryocytes. YTIC LEUKEMIA; ACUTE MEGAKARYOB LASTIC LEUKEMIA (FAB TYPE M7); FAB M7; ACUTE M7 MYELOID LEUKEMIA A progressive, proliferative disease of blood cells, originating from immature monocytes.

C3170

LEUKEMIA, ACUTE MEGAKARYOCYTIC, MALIGNANT

Acute Megakaryoblastic Leukemia

C4861

LEUKEMIA, ACUTE ACUTE MONOCYTIC, MALIGNANT MONOCYTIC LEUKEMIA (FAB M5B); MONOCYTIC LEUKEMIA LEUKEMIA, GRANULOCYTIC, MALIGNANT

Acute Monocytic Leukemia

C3172

LEUKEMIA A progressive, proliferative disease of blood cells, GRANULOCYTI originating from immature granulocytes. C; LEUKEMIA MYELOID; NON-LYMPHO BLASTIC LEUKEMIA; MYELOCYTIC LEUKEMIA; NON-LYMPHO CYTIC LEUKEMIA; MYELOGENOU S LEUKEMIA

Myeloid Leukemia

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 342 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4664

CDISC Submission Value LEUKEMIA, LARGE GRANULAR LYMPHOCYTIC, MALIGNANT

CDISC Definition

NCI Preferred Term T-Cell Large Granular Lymphocyte Leukemia

T-GAMMA A progressive, proliferative disease of blood cells LYMPHOPROLI which are large and granular, originating from FERATIVE lymphoid cells. DISORDER; LARGE CELL GRANULAR LYMPHOID LEUKEMIA; T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA; LGLL; TGAMMA LARGE GRANULAR LYMPHOCYTE LEUKEMIA; T GAMMA LYMPHOPROLI FERATIVE DISORDER; LARGE GRANULAR LYMPHOCYTO SIS; LARGE GRANULAR LYMPHOCYTIC LEUKEMIA; LARGE CELL GRANULAR LYMPHOGENO US LEUKEMIA LYMPHOGENO A progressive, proliferative disease of blood cells, US LEUKEMIA; originating from lymphoid cells. LYMPHOCYTIC LEUKEMIA LEUKEMIA NOS; LEUKEMIAS, GENERAL; LEUKEMIAS; BLOOD (LEUKEMIA) ADENOMA, INTERSTITIAL; BENIGN INTERSTITIAL CELL NEOPLASM; BENIGN INTERSTITIAL CELL TUMOR; BENIGN LEYDIG CELL NEOPLASM A progressive, proliferative disease of blood cells, originating from myeloid or lymphoid stem cells.

C7539

LEUKEMIA, LYMPHOCYTIC, MALIGNANT LEUKEMIA, MALIGNANT

Lymphoid Leukemia

C3161

Leukemia

C4212

LEYDIG CELL TUMOR, BENIGN

A benign neoplasm of the testis originating from interstitial (Leydig) cells.

Benign Leydig Cell Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 343 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym MALIGNANT INTERSTITIAL CELL TUMOR; MALIGNANT LEYDIG CELL NEOPLASM; MALIGNANT INTERSTITIAL CELL NEOPLASM LEYDIG CELL TUMOR; LEYDIG CELL NEOPLASM; INTERSTITIAL CELL NEOPLASM; INTERSTITIAL CELL TUMOR

NCI Code C4213

CDISC Submission Value LEYDIG CELL TUMOR, MALIGNANT

CDISC Definition A malignant neoplasm of the testis originating from interstitial (Leydig) cells.

NCI Preferred Term Malignant Leydig Cell Tumor

C3188

LEYDIG CELL TUMOR, UNDETERMINED

A neoplasm of the testis originating from interstitial (Leydig) cells, for which the malignancy status has not been established.

Leydig Cell Tumor

C3192 C3194 C3202

LIPOMA, BENIGN LIPOSARCOMA, MALIGNANT LUTEOMA, BENIGN MALIGNANT HIBERNOMA LUTEOMA; LUTEINOMA; LUTEAL CELL TUMOR; LUTEAL CELL NEOPLASM; OVARIAN STROMA LUTEOMA

A benign neoplasm composed of adipose tissue. A malignant neoplasm composed of adipose tissue. A benign neoplasm of the ovary, composed of leuteinized granulosa-theca cells.

Lipoma Liposarcoma Ovarian Stromal Luteoma

C8965 C3205

LYMPHANGIOMA, BENIGN LYMPHANGIOSARCOMA, MALIGNANT

A benign neoplasm arising from the lymphatics. MALIGNANT A malignant neoplasm arising from the endothelial LYMPHANGIO cells of the lymphatic vessels. ENDOTHELIOM A; LYMPHANGIO ENDOTHELIAL SARCOMA

Lymphangioma Lymphangiosarcoma

C3209

LYMPHOMA, FOLLICULAR, LYMPHOMA, A neoplasm of lymphoid cells which has at least a MALIGNANT FOLLICULAR partial follicular pattern. CENTRE CELL; FOLLICULAR CENTRE CELL LYMPHOMA; FOLLICLE CENTER LYMPHOMA; FOLLICULAR NON-HODGKIN LYMPHOMA; FOLLICULAR NON-HODGKIN 'S LYMPHOMA

Follicular Lymphoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 344 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C35382

CDISC Submission Value

CDISC Definition A malignant neoplasm of large lymphocytes, which resemble histiocytes.

NCI Preferred Term True Histiocytic Lymphoma

LYMPHOMA, HISTIOCYTIC, LYMPHOMA, MALIGNANT LARGE CELL, MALIGNANT LYMPHOMA, IMMUNOBLASTIC, MALIGNANT LYMPHOMA, LYMPHOBLASTIC, MALIGNANT

C3461

LYMPHOMA, A malignant neoplasm composed of immunoblasts LYMPHOCYTIC (large B cells). , MALIGNANT PRECURSOR CELL LYMPHOBLAS TIC LYMPHOMA; PRECURSOR LYMPHOBLAS TIC LYMPHOMA A malignant neoplasm composed of lymphoblasts (lymphoid precursor cells).

Immunoblastic Lymphoma

C9360

Lymphoblastic Lymphoma

C3212

LYMPHOMA, LYMPHOPLASMACYTIC, MALIGNANT

LYMPHOMA, A malignant neoplasm composed of lymphocytes PLASMACYTIC; (B-cells), lymphoplasmacytoid cells, and plasma cells. IMMUNOCYTO MA, LYMPHOPLAS MACYTIC TYPE; LYMPHOPLAS MACYTOID LYMPHOMA LYMPHOMA, A malignant neoplasm composed of lymphocytes of BPLEOMORPHIC or T/NK-cell phenotype. , MALIGNANT; LYMPHOMA (HODGKIN AND NON-HODGKIN ); LYMPHOMA (HODGKIN'S AND NON-HODGKIN 'S); MALIGNANT LYMPHOMA DIFFUSE MIXED LARGE AND SMALL CELL LYMPHOMA A malignant neoplasm composed of a mixed lymphocyte population.

Lymphoplasmacytic Lymphoma

C3208

LYMPHOMA, MALIGNANT

Lymphoma

C3463

LYMPHOMA, MIXED, MALIGNANT

Diffuse Mixed Cell Lymphoma

C7540

LYMPHOMA, SMALL LYMPHOCYTIC, MALIGNANT

SMALL B-CELL A malignant neoplasm composed of small LYMPHOCYTIC lymphocytes. LYMPHOMA; SLL; B-CELL SMALL LYMPHOCYTIC LYMPHOMA An antiquated term referring to a malignant lymphoma that is diffused and composed of small and large lymphocytes.

Small Lymphocytic Lymphoma

C26919

LYMPHOSARCOMA, MALIGNANT

Lymphosarcoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 345 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3217 C8991 C9295

CDISC Submission Value MAST CELL TUMOR, BENIGN MAST CELL TUMOR, MALIGNANT MAST CELL TUMOR, UNDETERMINED

CDISC Definition A benign neoplasm composed of mast cells. A malignant neoplasm composed of mast cells.

NCI Preferred Term Benign Mastocytoma Malignant Mastocytosis Mast Cell Neoplasm

MAST CELL A neoplasm composed of mast cells, for which the PROLIFERATIV malignancy status has not been determined. E DISEASE; TUMOR OF MAST CELLS; NEOPLASM OF MAST CELLS; MASTOCYTOSI S; NEOPLASM OF THE MAST CELLS; MAST CELL TUMOR; TUMOR OF THE MAST CELLS MEDULLOBLA STOMAS A malignant, invasive embryonal neoplasm arising from the cerebellum. A benign neoplasm or hamartoma composed of melanocytes. A malignant neoplasm composed of melanocytes, which lack melanin. MALIGNANT MELANOMA A malignant neoplasm composed of melanocytes.

C3222 C98709 C3802

MEDULLOBLASTOMA, MALIGNANT MELANOCYTOMA, BENIGN MELANOMA, AMELANOTIC, MALIGNANT MELANOMA, MALIGNANT MELANOMA, UVEAL, MALIGNANT

Medulloblastoma Benign Melanocytoma Amelanotic Melanoma

C3224 C7712

Melanoma Uveal Melanoma

MELANOMA A malignant neoplasm of the uvea composed of OF UVEA; melanocytes. MELANOMA OF THE UVEA; INTRAOCULAR MELANOMA A malignant neoplasm of the meninges, exhibiting poor differentiation (anaplasia).

C4051

MENINGIOMA, ANAPLASTIC ANAPLASTIC, MALIGNANT MENINGIOMA; MALIGNANT MENINGIOMA; MENINGIOMA, MALIGNANT MENINGIOMA, BENIGN MENINGIOMA, MALIGNANT MENINGIOMA, BENIGN

Anaplastic (Malignant) Meningioma

C4055 C38938

A benign neoplasm of the meninges.

Benign Meningioma Grade III Meningioma

GRADE III A malignant neoplasm of the meninges. MENINGIOMA; GRADE 3 MENINGIOMA; WHO GRADE III MENINGIOMA A neoplasm of the meninges, for which the status of malignancy has not been determined.

C3230

MENINGIOMA, UNDETERMINED

Meningioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 346 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4267

CDISC Submission Value MESENCHYMAL TUMOR, BENIGN

CDISC Definition

NCI Preferred Term Benign Mesenchymoma

BENIGN A benign soft-tissue neoplasm comprising two or CONNECTIVE more non-fibroblastic mesenchymal lines of AND SOFT differentiation. TISSUE NEOPLASM; BENIGN CONNECTIVE AND SOFT TISSUE TUMOR; BENIGN MESENCHYMA L CELL NEOPLASM; BENIGN NEOPLASM OF THE SOFT TISSUE AND BONE; BENIGN TUMOR OF THE SOFT TISSUE AND BONE ADENOMATOI A benign neoplasm arising from mesothelial cells. D TUMOR, BENIGN; BENIGN MESOTHELIOM A; MESOTHELIOM A, BENIGN; BENIGN NEOPLASM OF MESOTHELIUM ; BENIGN MESOTHELIAL NEOPLASM; BENIGN TUMOR OF MESOTHELIUM ; BENIGN MESOTHELIAL TUMOR; BENIGN LOCALIZED EPITHELIAL MESOTHELIOM A; BENIGN TUMOR OF THE MESOTHELIUM ; BENIGN NEOPLASM OF THE MESOTHELIUM

C3762

MESOTHELIOMA, BENIGN

Adenomatoid Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 347 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4456

CDISC Submission Value MESOTHELIOMA, MALIGNANT

CDISC Definition

NCI Preferred Term Malignant Mesothelioma

MALIGNANT A malignant neoplasm originating from mesothelial TUMOR OF cells of the pleura or peritoneum. MESOTHELIUM ; MALIGNANT NEOPLASM OF THE MESOTHELIUM ; MALIGNANT MESOTHELIAL TUMOR; MALIGNANT NEOPLASM OF MESOTHELIUM ; MALIGNANT MESOTHELIAL NEOPLASM; MALIGNANT TUMOR OF THE MESOTHELIUM A neoplasm originating from mesothelial cells of the pleura or peritoneum, for which the malignancy status has not been established. A benign neoplasm of the central nervous system with an astrocytic and oligodendrocytic component. A benign neoplasm composed of epithelial and/or myoepithelial cells and a mesenchymal component. MALIGNANT MIXED TUMOR A malignant neoplasm composed of epithelial and/or myoepithelial cells and a mesenchymal component. A general term for which the transformed cell types have not been specified. A neoplasm composed of an epithelial component and/or a mesenchymal component, for which the malignancy status has not been established. A general term for which the transformed cell types have not been specified. A malignant neoplasm of the female reproductive system (mostly uterus and ovaries) originating from the Muellerian ducts and composed of carcinomatous and sarcomatous elements.

C3234

MESOTHELIOMA, UNDETERMINED MIXED GLIOMA, BENIGN MIXED TUMOR, BENIGN MIXED TUMOR, MALIGNANT

Mesothelioma

C4050 C8602 C3729

Oligoastrocytoma Pleomorphic Adenoma Malignant Mixed Neoplasm

C6930

MIXED TUMOR, UNDETERMINED

TUMOR, MIXED; MIXED TUMOR

Mixed Neoplasm

C8975

MUELLERIAN TUMOR, MIXED, MALIGNANT

MALIGNANT MIXED MESODERMAL TUMOR; MALIGNANT MIXED MULLERIAN TUMOR; MMMT MYELIPOMA

Malignant Mixed Mesodermal (Mullerian) Tumor

C3736 C3242

MYELOLIPOMA, BENIGN

A benign tumor of the adrenal gland composed of adipocytes and hematopoietic/lymphoid cells. A malignant neoplasm of the bone marrow composed of plasma cells. A benign neoplasm composed of myoepithelial cells.

Adrenal Gland Myelolipoma Plasma Cell Myeloma

MYELOMA, PLASMA CELL, MYELOMA; MALIGNANT MULTIPLE MYELOMA MYOEPITHELIOMA, BENIGN

C7442

Benign Myoepithelioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 348 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym MYOEPITHELI AL CARCINOMA; MALIGNANT MYOEPITHELI OMA

NCI Code C7596

CDISC Submission Value MYOEPITHELIOMA, MALIGNANT

CDISC Definition A malignant neoplasm composed of myoepithelial cells.

NCI Preferred Term Malignant Myoepithelioma

C6577 C3255 C4743 C7586 C3677

MYXOMA, BENIGN MYXOSARCOMA, MALIGNANT NEOPLASM, BASAL CELL, BENIGN NEOPLASM, BASAL CELL, MALIGNANT NEOPLASM, BENIGN BENIGN TUMOR; BENIGN UNCLASSIFIAB LE TUMOR MALIGNANCY; CA; CANCER; MALIGNANT TUMOR

A benign soft tissue neoplasm with a myxoid stroma formation. A malignant soft tissue neoplasm with a myxoid stroma formation. BENIGN BASAL A benign neoplasm composed of basal cells. CELL TUMOR A malignant neoplasm composed of basal cells. A general term used to describe autonomous growth of tissue where the originating cell type has not been characterized. The term benign indicates the absence of morphologic features associated with malignancy (for instance severe atypia, nuclear pleomorphism, tumor cell necrosis, and abnormal mitoses). A general term for autonomous tissue growth exhibiting morphologic features of malignancy (e.g. severe atypia, nuclear pleomorphism, tumor cell necrosis, abnormal mitoses, tissue invasiveness) and for which the transformed cell type has not been specifically identified. A general term for autonomous tissue growth in which the malignancy status has not been established and for which the transformed cell type has not been specifically identified. EMBRYONAL A malignant embryonal neoplasm of the kidney. NEPHROMA; NEPHROBLAST OMA; WILMS TUMOR OF THE KIDNEY; RENAL WILMS' TUMOR; WILMS' TUMOR OF THE KIDNEY NEUROENDOC RINE TUMOR NOS; NEUROENDOC RINE TUMOR A neoplasm composed of cells of neuroendocrine origin for which the malignancy status has not been established.

Myxoma Myxosarcoma Benign Basal Cell Neoplasm Malignant Basal Cell Neoplasm Benign Neoplasm

C9305

NEOPLASM, MALIGNANT

Malignant Neoplasm

C3262

NEOPLASM, UNDETERMINED

Neoplasm

C40407

NEPHROBLASTOMA, MALIGNANT

Renal Wilms Tumor

C3809

NEURAL CREST TUMOR, UNDETERMINED

Neuroendocrine Neoplasm

C3270

NEUROBLASTOMA, MALIGNANT

NEUROBLASTO A malignant neoplasm composed of neuroblastic cells. MA (SCHWANNIAN STROMA-POOR )

Neuroblastoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 349 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3789

CDISC Submission Value NEUROBLASTOMA, OLFACTORY, MALIGNANT

CDISC Definition

NCI Preferred Term Olfactory Neuroblastoma

ESTHESIONEU A malignant neoplasm of the olfactory receptor cells, ROBLASTOMA; composed of neuroblastic cells. OLFACTORY ESTHESIONEU ROBLASTOMA; ESTHESIONEU ROBLASTOMA; ESTHESIONEU ROEPITHELIO MA; OLFACTORY NEUROEPITHE LIOMA An intraneural or extraneural neoplasm arising from nerve tissues and neural sheaths, composed of perineurial-like fibroblasts and Schwann cells. GLIOMA; NEOPLASM OF THE NEUROGLIA; NEUROGLIAL NEOPLASMS; TUMOR OF THE NEUROGLIA; TUMORS OF NEUROGLIA; TUMOR OF NEUROGLIA; NEOPLASMS OF NEUROGLIA; GLIAL NEOPLASM; GLIAL TUMOR; GLIOMA; NEOPLASM OF NEUROGLIA; NEUROGLIAL NEOPLASM A neoplasm of the central nervous system composed of glial cells (astrocytes, oligodendrocytes, ependymal cells), for which the malignancy status has not been determined.

C3272

NEUROFIBROMA, BENIGN

Neurofibroma

C3059

NEUROGLIAL TUMOR, UNDETERMINED

Neuroglial Tumor

C4306

ODONTOGENIC TUMOR, BENIGN ODONTOGENIC TUMOR, UNDETERMINED

BENIGN A benign neoplasm arising from tooth-forming tissues. ODONTOGENIC TUMOR ODONTOMA, A neoplasm arising from tooth-forming tissues, for UNDETERMINE which the malignancy status has not been established. D; ODONTOGENIC TUMOR AMELOBLASTI A benign neoplasm arising from tooth-forming tissues C with-enamel organ differentiation (but without enamel FIBROODONTO formation). MA; FIBROAMELOB LASTIC ODONTOMA

Benign Odontogenic Neoplasm

C3286

Odontogenic Neoplasm

C3710

ODONTOMA, AMELOBLASTIC, BENIGN

Ameloblastic Fibro-Odontoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 350 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C7492

CDISC Submission Value ODONTOMA, AMELOBLASTIC, MALIGNANT ODONTOMA, BENIGN

CDISC Definition A malignant neoplasm arising from tooth-forming tissues with-enamel organ differentiation (but without enamel formation).

NCI Preferred Term Ameloblastic Carcinoma

C3287

FIBROODONTO A benign neoplasm of tooth origin. MA; FIBRO-ODONT OMA ODONTOGENIC A malignant neoplasm of tooth origin. CARCINOMA; MALIGNANT ODONTOGENIC TUMOR; ODONTOGENIC CARCINOSARC OMA

Odontoma

C4812

ODONTOMA, MALIGNANT

Malignant Odontogenic Neoplasm

C4326

OLIGODENDROGLIOMA, WHO GRADE III A malignant neoplasm of the central nervous system ANAPLASTIC, MALIGNANT OLIGODENDR arising from oligodendrocytes, exhibiting poor OGLIAL differentiation (anaplasia). NEOPLASM; OLIGODENDR OGLIOMA; MALIGNANT; MALIGNANT OLIGODENDR OGLIOMA; WHO GRADE III OLIGODENDR OGLIAL TUMOR; UNDIFFERENTI ATED OLIGODENDR OGLIOMA OLIGODENDROGLIOMA, UNDETERMINED WELL DIFFERENTIAT ED OLIGODENDR OGLIOMA; WELL DIFFERENTIAT ED OLIGODENDR OGLIAL TUMOR; WHO GRADE II OLIGODENDR OGLIAL TUMOR; WHO GRADE II OLIGODENDR OGLIAL NEOPLASM A neoplasm of the central nervous system arising from oligodendrocytes, for which the malignancy status has not been determined.

Anaplastic Oligodendroglioma

C3288

Oligodendroglioma

C7072

ONCOCYTOMA, BENIGN

ONCOCYTOMA A benign neoplasm composed of large cells with ; ONCOCYTIC abundant eosinophilic granular cytoplasm (oncocytes). TUMOR

Oncocytic Neoplasm

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 351 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3679

CDISC Submission Value ONCOCYTOMA, MALIGNANT

CDISC Definition

NCI Preferred Term Oxyphilic Adenocarcinoma

HURTHLE A malignant neoplasm composed of large epithelial CELL cells with abundant granular eosinophilic cytoplasm CARCINOMA; (oncocytes). HURTHLE CELL ADENOCARCIN OMA; ONCOCYTIC ADENOCARCIN OMA; ONCOCYTIC CARCINOMA GIANT OSTEOID OSTEOMA; OSSIFYING GIANT CELL TUMOR A benign neoplasm of bone, characterized by the formation of osteoid tissue and large osteoblast-like cells.

C3294

OSTEOBLASTOMA, BENIGN

Osteoblastoma

C3295 C7155

OSTEOCHONDROMA, BENIGN OSTEOCHONDROSARCOM A, MALIGNANT

A benign cartiliginous neoplasm arising from the metaphysis of bone. PRIMARY A malignant cartiliginous neoplasm of bone. CHONDROSAR COMA; CONVENTIONA L CHONDROSAR COMA OF BONE; PRIMARY CHONDROSAR COMA OF THE BONE; PRIMARY CHONDROSAR COMA OF BONE; PRIMARY BONE CHONDROSAR COMA GIANT CELL SARCOMA OF THE BONE; GIANT CELL SARCOMA OF BONE; GIANT CELL BONE SARCOMA; DEDIFFERENTI ATED GIANT CELL TUMOR A malignant neoplasm of bone comprised of osteoclast-like giant cells and mononuclear cells.

Osteochondroma Conventional Chondrosarcoma

C4304

OSTEOCLASTOMA, MALIGNANT

Malignant Giant Cell Tumor of Bone

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 352 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym GIANT CELL NEOPLASM OF BONE; BONE GIANT CELL TUMOR; BONE GIANT CELL NEOPLASM OSTEOFIBROM A, BONE; DESMOID TUMOR OF BONE; DESMOPLASTI C FIBROMA OF BONE; DESMOPLASTI C FIBROMA OF THE BONE; DESMOPLASTI C FIBROMA; OSSEOUS DESMOPLASTI C FIBROMA

NCI Code C3738

CDISC Submission Value OSTEOCLASTOMA, UNDETERMINED

CDISC Definition A neoplasm of bone comprised of osteoclast-like giant cells and mononuclear cells, for which the malignancy status has not been established.

NCI Preferred Term Giant Cell Tumor of Bone

C3740

OSTEOFIBROMA, BENIGN

A benign neoplasm characterized by osteolysis and the presence of a rich collagenous stroma and spindle cells.

Bone Desmoplastic Fibroma

C3296 C8810

OSTEOMA, BENIGN OSTEOSARCOMA, EXTRASKELETAL, MALIGNANT

A benign well-differentiated neoplasm of bone. OSSIFYING A malignant bone-forming neoplasm, arising in tissue SARCOMA; other than bone. EXTRAOSSEOU S OSTEOSARCO MA; EXTRASKELET AL OSTEOGENIC SARCOMA; SOFT TISSUE OSTEOSARCO MA OSTEOGENIC SARCOMA; OSTEOGENIC SARCOMA A malignant neoplasm usually arising from bone.

Osteoma Extraskeletal Osteosarcoma

C9145

OSTEOSARCOMA, MALIGNANT

Osteosarcoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 353 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C6803

CDISC Submission Value OVARIAN SEX CORD-STROMAL TUMOR, BENIGN

CDISC Definition

NCI Preferred Term Benign Ovarian Sex Cord-Stromal Tumor

SEX CORD A benign neoplasm of the ovary, originating from the STROMAL sex-cord stroma. TUMOR, BENIGN; BENIGN SEX CORD-STROMA L NEOPLASM OF THE OVARY; BENIGN SEX CORD-STROMA L TUMOR OF THE OVARY; BENIGN OVARIAN SEX CORD-STROMA L NEOPLASM; BENIGN SEX CORD-STROMA L TUMOR OF OVARY; BENIGN SEX CORD-STROMA L NEOPLASM OF OVARY A benign epithelial neoplasm that projects above the surrounding epithelial surface. PAPILLOMA OF A benign neoplasm of the choroid plexus of the central CHOROID nervous system. PLEXUS; PAPILLOMA OF THE CHOROID PLEXUS EPIDERMOID PAPILLOMA; EPIDERMOID CELL PAPILLOMA; KERATOTIC PAPILLOMA; SQUAMOUS CELL PAPILLOMA A benign epithelial neoplasm characterized by a papillary growth pattern and a proliferation of neoplastic squamous cells.

C7440 C3698

PAPILLOMA, BENIGN PAPILLOMA, CHOROID PLEXUS, BENIGN

Papilloma Choroid Plexus Papilloma

C3712

PAPILLOMA, SQUAMOUS CELL, BENIGN

Squamous Papilloma

C4115

PAPILLOMA, TRANSITIONAL CELL, BENIGN

TRANSITIONAL A benign papillary neoplasm composed of transitional PAPILLOMA cells.

Transitional Cell Papilloma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 354 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C48314

CDISC Submission Value PARAGANGLIOMA, BENIGN

CDISC Definition

NCI Preferred Term Benign Paraganglioma

NEURAL A benign neoplasm arising from paraganglia located CREST TUMOR, along nerves composed of neoplastic neuroectodermal BENIGN; chromaffin cells. NEUROENDOC RINE TUMOR, BENIGN; BENIGN PARAGANGLIO NIC NEOPLASM; BENIGN NEUROENDOC RINE CELL TUMOR MALIGNANT A malignant neoplasm arising from paraganglia located TUMOR OF THE along nerves composed of neoplastic neuroectodermal PARAGANGLIO chromaffin cells. N; MALIGNANT TUMOR OF PARAGANGLIO N; MALIGNANT PARAGANGLIO NIC NEOPLASM; MALIGNANT PARAGANGLIO NIC TUMOR; MALIGNANT NEOPLASM OF PARAGANGLIO N; MALIGNANT PARAGANGLIO N NEOPLASM; MALIGNANT PARAGANGLIO N TUMOR; PARAGANGLIO N NEOPLASM; MALIGNANT; MALIGNANT NEOPLASM OF THE PARAGANGLIO N

C8559

PARAGANGLIOMA, MALIGNANT

Malignant Paraganglioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 355 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym PARAGANGLIO N NEOPLASM; NEOPLASM OF PARAGANGLIO N; TUMOR OF THE PARAGANGLIO N; PARAGANGLIO N TUMOR; TUMOR OF PARAGANGLIO N; PARAGANGLIO NIC NEOPLASM; PARAGANGLIO NIC TUMOR; NEOPLASM OF THE PARAGANGLIO N

NCI Code C3308

CDISC Submission Value PARAGANGLIOMA, UNDETERMINED

CDISC Definition A neoplasm arising from paraganglia located along nerves composed of neoplastic neuroectodermal chromaffin cells, for which the malignancy status has not been established.

NCI Preferred Term Paraganglioma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 356 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3798

CDISC Submission Value PERIPHERAL NERVE SHEATH TUMOR, MALIGNANT

CDISC Definition

NCI Preferred Term Malignant Peripheral Nerve Sheath Tumor

MALIGNANT A malignant neoplasm, originating from the sheaths of NEURILEMMO the peripheral nerve. MA; MALIGNANT SCHWANNOM A; NEUROFIBROS ARCOMA, MALIGNANT; MALIGNANT NEOPLASM OF PERIPHERAL NERVE SHEATH; MALIGNANT NEOPLASM OF THE PERIPHERAL NERVE SHEATH; MALIGNANT NEURILEMMO MA; MALIGNANT NEURILEMOM A; MALIGNANT PERIPHERAL NERVE SHEATH NEOPLASM; MALIGNANT PERIPHERAL NERVE SHEATH TUMOUR; MALIGNANT TUMOR OF PERIPHERAL NERVE SHEATH; MALIGNANT TUMOR OF THE PERIPHERAL NERVE SHEATH; MPNST A benign neoplasm of the adrenal gland medulla. A benign neoplasm of the adrenal gland medulla, composed of medullary and neuroectodermal components. A neoplasm of the adrenal gland medulla, composed of medullary and neuroectodermal components, for which the malignancy status has not been established. A malignant neoplasm of the adrenal gland medulla, composed of medullary and neuroectodermal components.

C48305 C92181

PHEOCHROMOCYTOMA, BENIGN PHEOCHROMOCYTOMA, COMPLEX, BENIGN PHEOCHROMOCYTOMA, COMPLEX, UNDETERMINED PHEOCHROMOCYTOMA, COMPLEX,MALIGNANT

Benign Adrenal Gland Pheochromocytoma Benign Adrenal Gland Composite Pheochromocytoma Adrenal Gland Composite Pheochromocytoma Malignant Adrenal Gland Composite Pheochromocytoma

C48306

C92184

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 357 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C4220

CDISC Submission Value PHEOCHROMOCYTOMA, MALIGNANT

CDISC Definition

NCI Preferred Term Malignant Adrenal Gland Pheochromocytoma

MALIGNANT A malignant neoplasm of the adrenal gland medulla. PHEOCHROMO CYTOMA; MALIGNANT ADRENAL MEDULLARY PHEOCHROMO CYTOMA; MALIGNANT ADRENAL PHEOCHROMO CYTOMA; MALIGNANT ADRENAL GLAND PARAGANGLIO MA; MALIGNANT ADRENAL GLAND CHROMAFFINO MA; MALIGNANT ADRENAL GLAND CHROMAFFIN NEOPLASM; MALIGNANT ADRENAL GLAND CHROMAFFIN TUMOR; MALIGNANT ADRENAL GLAND CHROMAFFIN PARAGANGLIO MA; PHEOCHROMO BLASTOMA; MALIGNANT ADRENAL MEDULLARY PARAGANGLIO MA

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 358 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3326

CDISC Submission Value PHEOCHROMOCYTOMA, UNDETERMINED

CDISC Definition

NCI Preferred Term Adrenal Gland Pheochromocytoma

ADRENAL A neoplasm of the adrenal gland medulla, for which the PHEOCHROMO malignancy status has not been established. CYTOMA; CHROMAFFIN PARAGANGLIO MA OF THE ADRENAL GLAND; INTRAADRENA L PARAGANGLIO MA; ADRENAL MEDULLARY PARAGANGLIO MA; ADRENAL GLAND PARAGANGLIO MA; ADRENAL MEDULLARY PHEOCHROMO CYTOMA; PCC; ADRENAL GLAND CHROMAFFIN PARAGANGLIO MA; PHAEOCHROM OCYTOMA; ADRENAL GLAND CHROMAFFINO MA; PHEOCHROMO CYTOMA A benign adnexal neoplasm arising from hair-bearing skin surfaces.

C7368

PILOMATRIXOMA, BENIGN BENIGN PILOMATRICO MA; PILOMATRIXO MA; CALCIFYING EPITHERLIOM A OF MALHERBE; BENIGN PILOMATRIXO MA; BENIGN HAIR FOLLICLE NEOPLASM

Pilomatricoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 359 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C9344

CDISC Submission Value PINEOBLASTOMA, MALIGNANT

CDISC Definition

NCI Preferred Term Pineoblastoma

PINEAL GLAND A poorly differentiated malignant embryonal neoplasm PNET; PINEAL arising from the pineal region of the brain. GLAND PRIMITIVE NEUROECTOD ERMAL NEOPLASM; PINEAL GLAND PRIMITIVE NEUROECTOD ERMAL TUMOR; PINEAL PNET; PINEAL PRIMITIVE NEUROECTOD ERMAL NEOPLASM; PINEAL PRIMITIVE NEUROECTOD ERMAL TUMOR; PNET OF PINEAL GLAND; PNET OF THE PINEAL GLAND; PRIMITIVE NEUROECTOD ERMAL NEOPLASM OF PINEAL GLAND; PRIMITIVE NEUROECTOD ERMAL NEOPLASM OF THE PINEAL GLAND; PRIMITIVE NEUROECTOD ERMAL TUMOR OF PINEAL GLAND; PRIMITIVE NEUROECTOD ERMAL TUMOR OF THE PINEAL GLAND PINEALOMA; BENIGN PINEALOMA A benign neoplasm of the brain arising from the pineal gland.

C6966

PINEOCYTOMA, BENIGN

Pineocytoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 360 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym POSTERIOR PITUITARY TUMOR; POSTERIOR PITUITARY GLAND TUMOR; NEUROHYPOP HYSIS NEOPLASM; NEUROHYPOP HYSIS TUMOR; POSTERIOR PITUITARY NEOPLASM PLASMACYTIC TUMOR; PLASMA CELL DYSCRASIA; PLASMACYTIC TUMOR; PLASMA CELL TUMOR; PLASMACYTIC NEOPLASM POLYPOID ADENOMA

NCI Code C7157

CDISC Submission Value PITUICYTOMA, BENIGN

CDISC Definition A neoplasm arising from the posterior lobe of the pituitary gland.

NCI Preferred Term Posterior Pituitary Gland Neoplasm

C4665

PLASMA CELL TUMOR, MALIGNANT

A malignant neoplasm composed of plasma cells.

Plasma Cell Neoplasm

C3764

POLYP, ADENOMATOUS, UNDETERMINED POLYP, ENDOMETRIAL STROMAL, BENIGN

A neoplasm, originating from glandular epithelium, exhibiting polypoid growth, for which the malignancy status has not been determined.

Adenomatous Polyp

C6433

POLYP, A benign polypoid neoplasm of the endometrium STROMAL; projecting into the endometrial cavity. POLYP OF THE ENDOMETRIU M; ENDOMETRIAL STROMAL POLYP; POLYP OF ENDOMETRIU M; ADENOMA; ENDOMETRIAL ; GLANDULAR ENDOMETRIAL POLYP; ENDOMETRIAL ADENOMA INFLAMMATO RY POLYP OF THE LARGE BOWEL; LARGE BOWEL INFLAMMATO RY POLYP; INFLAMMATO RY POLY OF LARGE BOWEL A non-neoplastic inflammatory polypoid lesion in the colon and rectum.

Endometrial Polyp

C5680

POLYP, INFLAMMATORY, BENIGN

Colorectal Inflammatory Polyp

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 361 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C3340

CDISC Submission Value POLYP, UNDETERMINED

CDISC Definition A protruding growth attached to the underlying tissue by a broad base or a thin stalk, which can be either inflammatory, hamartomatous, or neoplastic. Polyp

NCI Preferred Term

C3664

POLYP, VAGINAL, BENIGN

POLYP OF THE VAGINA; POLYP OF VAGINA

A benign polypoid growth arising from the vaginal wall.

Vaginal Polyp

C4684

RETICULOSIS, MALIGNANT ANGIOCENTRI C T-CELL LYMPHOMA RETINOBLASTOMA, MALIGNANT RHABDOMYOMA, BENIGN RHABDOMYOSARCOMA, MALIGNANT SARCOMA, GRANULOCYTIC, MALIGNANT SARCOMA, HISTIOCYTIC, MALIGNANT SARCOMA, LEPTOMENINGEAL, MALIGNANT SARCOMA, MENINGEAL; SARCOMA OF LEPTOMENING ES; SARCOMA OF THE LEPTOMENING ES SARCOMA OF SOFT TISSUE AND BONE; SARCOMA OF THE SOFT TISSUE AND BONE; SARCOMA; MESENCHYMA L TUMOR, MALIGNANT CHLOROMA; EXTRAMEDUL LARY MYELOID TUMOR SS RB

A malignant lymphoid neoplasm composed of EBV-positive NK/T cells arranged in an angiocentric pattern. A malignant neoplasm originating in the nuclear layer of the retina. A benign neoplasm arising from skeletal muscle, characterized by the presence of rhabdomyoblasts. A malignant mesenchymal neoplasm arising from skeletal muscle. A malignant neoplasm composed of myeloblasts, neutrophils and neutrophil precursors. A malignant neoplasm composed of cells resembling histiocytes. A malignant mesenchymal neoplasm arising from the leptomeninges.

Nasal Type Extranodal NK/T-Cell Lymphoma Retinoblastoma Rhabdomyoma Rhabdomyosarcoma Granulocytic Sarcoma

C7541 C3358 C3359 C35815

C27349 C8312

Histiocytic Sarcoma Leptomeningeal Sarcoma

C9118

SARCOMA, MALIGNANT

A malignant mesenchymal neoplasm. A general term for which the transformed cell type has not been specified.

Sarcoma

C3520

SARCOMA, MYELOID, MALIGNANT

A malignant neoplasm composed of myeloblasts or immature myeloid cells. It occurs in extramedullary sites or the bone.

Myeloid Sarcoma

C3400

SARCOMA, SYNOVIAL, MALIGNANT

A malignant neoplasm that usually arises in the synovial membranes of the joints and the synovial cells of the tendons and bursae.

Synovial Sarcoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 362 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C27096

CDISC Submission Value SARCOMA, UNDIFFERENTIATED, MALIGNANT SCHWANNOMA, BENIGN

CDISC Definition

NCI Preferred Term Undifferentiated Embryonal Sarcoma

EMBRYONAL A rare malignant neoplasm of the liver that is most SARCOMA, common in youth. UNDIFFERENTI ATED NEURILEMMO MA; SCHWANNOM A; NEURINOMA; SCHWANNOM A (WHO GRADE I) SEMINOMA, PURE; SEMINOMA ARRHENOBLA STOMA, BENIGN; BENIGN ANDROBLAST OMA ARRHENOBLA STOMA, MALIGNANT; MALIGNANT ANDROBLAST OMA A benign neoplasm of the peripheral nervous system composed of well-differentiated Schwann cells.

C3269

Schwannoma

C9309

SEMINOMA, MALIGNANT

A malignant germ cell neoplasm of the testis.

Seminoma

C67012

SERTOLI CELL TUMOR, BENIGN

A benign neoplasm of the testis or ovary, originating from Sertoli cells.

Benign Sertoli Cell Tumor

C67006

SERTOLI CELL TUMOR, MALIGNANT

A malignant neoplasm of the testis or ovary, originating from Sertoli cells.

Malignant Sertoli Cell Tumor

C98794 C6569

SERTOLI CELL TUMOR, UNDETERMINED STROMAL NEPHROMA, MALIGNANT STROMAL SARCOMA, ENDOMETRIAL, MALIGNANT STROMAL SARCOMA, MALIGNANT STROMAL TUMOR, BENIGN STROMAL TUMOR, GONADAL, MALIGNANT SEX CORD STROMAL TUMOR, MALIGNANT CMN; MESOBLASTIC NEPHROMA ESS

An ovarian neoplasm comprising Sertoli cells in which the malignancy status has not been established. A congenital malignant neoplasm of the kidney characterized by the presence of fibroblastic cells. A malignant, mesenchymal tumor of the uterine stroma. A malignant neoplasm characterized by the presence of atypical mesenchymal-stromal cells. A benign neoplasm composed of mesenchymal stromal cells. A malignant neoplasm originating from the gonadal sex cord stroma.

Undetermined Sertoli Cell Tumor Congenital Mesoblastic Nephroma

C8973

Endometrial Stromal Sarcoma

C6926

STROMAL TUMOR, MALIGNANT

Stromal Sarcoma

C66772 C67561

Benign Stromal Tumor Malignant Sex Cord-Stromal Tumor

C3794

STROMAL TUMOR, GONADAL, UNDETERMINED

SEX A neoplasm originating from the gonadal sex cord CORD-STROMA stroma, for which the status of malignancy has not L TUMOR, been determined. UNDETERMINE D; SEX CORD-STROMA L NEOPLASM

Sex Cord-Stromal Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 363 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym WHO GRADE I EPENDYMAL TUMOR; WHO GRADE I EPENDYMAL NEOPLASM; SUBEPENDYM AL GLIOMA

NCI Code C3795

CDISC Submission Value SUBEPENDYMOMA, BENIGN

CDISC Definition A benign neoplasm of the brain localized in the vicinity of a ventricular wall and is composed of glial tumor cell clusters embedded in an abundant fibrillary matrix with frequent microcystic changes.

NCI Preferred Term Subependymoma

C3829

SYNOVIOMA, BENIGN

BENIGN A benign neoplasm arising from the synovial NEOPLASM OF membrane. SYNOVIUM; BENIGN SYNOVIOMA; BENIGN NEOPLASM OF THE SYNOVIUM; BENIGN TUMOR OF THE SYNOVIUM; BENIGN TUMOR OF SYNOVIUM; BENIGN SYNOVIAL TUMOR A benign germ-cell neoplasm derived from pluripotent cells and consisting of components from one or more of the three germ-cell layers. IMMATURE TERATOMA A malignant germ-cell neoplasm derived from pluripotent cells and consisting of components from one or more of the three germ-cell layers. A germ-cell neoplasm derived from pluripotent cells and consisting of components from one or more of the three germ-cell layers, for which the malignancy status has not been established.

Benign Synovial Neoplasm

C67107

TERATOMA, BENIGN

Benign Teratoma

C4286

TERATOMA, MALIGNANT

Immature Teratoma

C3403

TERATOMA, UNDETERMINED

Teratoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 364 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C5219

CDISC Submission Value THECOMA, BENIGN

CDISC Definition

NCI Preferred Term Benign Ovarian Thecoma

THECAL CELL A benign sex-cord neoplasm of the ovary, originating TUMOR, from theca cells. BENIGN; BENIGN THECAL CELL NEOPLASM OF THE OVARY; BENIGN OVARIAN THECAL CELL TUMOR; BENIGN OVARIAN THECAL CELL NEOPLASM; BENIGN THECAL CELL TUMOR OF THE OVARY; BENIGN THECAL CELL TUMOR OF OVARY; BENIGN THECOMA OF THE OVARY; BENIGN THECOMA OF OVARY; BENIGN THECAL CELL NEOPLASM OF OVARY

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 365 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C6929

CDISC Submission Value THECOMA, OVARIAN, MALIGNANT

CDISC Definition

NCI Preferred Term Malignant Ovarian Thecoma

THECOMA, A malignant sex-cord neoplasm of the ovary, MALIGNANT; originating from theca cells. MALIGNANT THECOMA OF THE OVARY; MALIGNANT THECAL CELL NEOPLASM OF THE OVARY; MALIGNANT THECAL CELL NEOPLASM OF OVARY; MALIGNANT OVARIAN THECAL CELL NEOPLASM; MALIGNANT THECAL CELL TUMOR OF THE OVARY; MALIGNANT THECOMA OF OVARY; MALIGNANT OVARIAN THECAL CELL TUMOR; MALIGNANT THECAL CELL TUMOR OF OVARY A benign neoplasm of the thymus, originating from epithelial thymus cells. A malignant neoplasm of the thymus, originating from epithelial thymus cells. A neoplasm of the thymus, originating from epithelial thymus cells, for which the malignancy status has not been established.

C66746 C7612 C3411

THYMOMA, BENIGN THYMOMA, MALIGNANT THYMOMA, UNDETERMINED

Benign Thymoma Malignant Thymoma Thymoma

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 366 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C88025 - NEOPLASM - Neoplasm Type Codelist extensible: Yes
CDISC Synonym

NCI Code C27132

CDISC Submission Value TRICHOEPITHELIOMA, BENIGN

CDISC Definition

NCI Preferred Term Trichoblastoma

BROOKE'S A benign hair follicle neoplasm with trichoblastic TUMOR; differentiation. TRICHOGENIC TRICHOBLAST OMA; TRICHOGENIC ADNEXAL TUMOR; TRICHOEPITHE LIOMA ENDODERMAL SINUS TUMOR; YOLK SAC TUMOR SITE UNSPECIFIED; YOLK SAC NEOPLASM; ENDODERMAL SINUS NEOPLASM A non-seminomatous malignant germ cell tumor composed of primitive germ cells and which produce an eosinophilic substance (alpha-fetoprotein).

C3011

YOLK SAC TUMOR, MALIGNANT

Yolk Sac Tumor

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 367 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101860 - NORMABNM - Normal Abnormal Response Codelist extensible: No
CDISC Synonym

NCI Code C25401

CDISC Submission Value ABNORMAL

CDISC Definition Deviating in any way from the state, position, structure, condition, behavior, or rule which is considered a norm. (NCI)

NCI Preferred Term Abnormal

C48658 C14165

INDETERMINATE NORMAL

Inconclusive

Cannot distinguish between two or more possible values in the current context. (NCI) Being approximately average or within certain limits; conforming with or constituting a norm or standard or level or type or social norm. (NCI) Not known, not observed, not recorded, or refused. (NCI)

Indeterminate Normal

C17998

UNKNOWN

Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 368 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78736 - NRIND - Reference Range Indicator Codelist extensible: Yes
CDISC Synonym

NCI Code C78802 C78800 C78801 C78727

CDISC Submission Value ABNORMAL HIGH LOW NORMAL

CDISC Definition Reported values outside the typical or expected range. (NCI) Reported values above the typical or expected range. (NCI) Reported values below the typical or expected range. (NCI) Reported values within the typical or expected range. (NCI)

NCI Preferred Term Abnormal Reference Range Value Above Reference Range Value Below Reference Range Normal Reference Range

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 369 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101861 - NSYSPCID - Non-system Reason for PCI Delay Codelist extensible: No
CDISC Synonym

NCI Code C99920 C99945 C99946

CDISC Submission Value CARDIAC ARREST BEFORE PCI DIFFICULT VASCULAR ACCESS DIFFICULTY CROSSING THE CULPRIT LESION DURING THE PCI PROCEDURE ENDOTRACHEAL INTUBATION BEFORE PCI OTHER SUBJECT DELAY IN PROVIDING CONSENT

CDISC Definition Cardiac arrest which occurs before a percutaneous coronary intervention can take place. Access to the subject's vasculature is troublesome or formidable. Placement of intracoronary devices across the coronary stenosis is troublesome or formidable.

NCI Preferred Term Cardiac Arrest Prior to Percutaneous Coronary Intervention Difficult Vascular Access Difficulty Crossing Culprit Lesion During Percutaneous Coronary Intervention Endotracheal Intubation before Percutaneous Coronary Intervention Other Subject Delay in Providing Consent

C99950 C17649 C100016

Intubation before PCI Other Patient Delay in Providing Consent

Endotracheal intubation which occurs before a percutaneous coronary intervention can take place. Different than the one(s) previously specified or mentioned. (NCI) The subject has not provided consent in a timely manner for the procedure to take place.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 370 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66742 - NY - No Yes Response Codelist extensible: No
CDISC Synonym No NA U; Unknown Yes

NCI Code C49487 C48660 C17998 C49488

CDISC Submission Value N NA U Y

CDISC Definition The non-affirmative response to a question. (NCI) Determination of a value is not relevant in the current context. (NCI) Not known, not observed, not recorded, or refused. (NCI) The affirmative response to a question. (NCI) No

NCI Preferred Term

Not Applicable Unknown Yes

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 371 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101862 - NYHAC - New York Heart Association Class Responses Codelist extensible: No
CDISC Synonym New York Heart Association Class I New York Heart Association Class II New York Heart Association Class III New York Heart Association Class IV

NCI Code C66904

CDISC Submission Value NYHA CLASS I

CDISC Definition Without limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitations, or dyspnea. Slight limitation of physical activity. The patient is comfortable at rest. Ordinary physical activity results in fatigue, palpitations, or dyspnea. Marked limitation of physical activity. The patient is comfortable at rest. Less than ordinary activity causes fatigue, palpitations, or dyspnea. Inability to carry on any physical activity without discomfort. Heart failure symptoms are present even at rest or with minimal exertion.

NCI Preferred Term New York Heart Association Class I

C66905

NYHA CLASS II

New York Heart Association Class II

C66907

NYHA CLASS III

New York Heart Association Class III New York Heart Association Class IV

C66908

NYHA CLASS IV

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 372 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66768 - OUT - Outcome of Event Codelist extensible: No
CDISC Synonym Grade 5; 5; FATAL

NCI Code C48275 C49494

CDISC Submission Value FATAL NOT RECOVERED/NOT RESOLVED RECOVERED/RESOLVED

CDISC Definition The termination of life as a result of an adverse event. (NCI) One of the possible results of an adverse event outcome that indicates that the event has not improved or recuperated. (NCI) One of the possible results of an adverse event outcome that indicates that the event has improved or recuperated. (NCI) One of the possible results of an adverse event outcome where the subject recuperated but retained pathological conditions resulting from the prior disease or injury. (NCI) One of the possible results of an adverse event outcome that indicates that the event is improving. (NCI)

NCI Preferred Term Death Related to Adverse Event Not Recovered or Not Resolved

C49498

Recovered or Resolved

C49495

RECOVERED/RESOLVED WITH SEQUELAE

Recovered or Resolved with Sequelae

C49496

RECOVERING/RESOLVING

Recovering or Resolving

C17998

UNKNOWN

U; Unknown

Not known, not observed, not recorded, or refused. (NCI)

Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 373 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C95120 - PHSPRP - Physical Properties Test Name Codelist extensible: Yes
CDISC Synonym Color

NCI Code C37927

CDISC Submission Value Color

CDISC Definition The appearance of objects (or light sources) described in terms of a person's perception of their hue and lightness (or brightness) and saturation. (NCI) A description about the firmness or make-up of an entity. The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness. (NCI) A written or verbal account, representation, statement, or explanation of something. (NCI) The length of a straight line passing through the center of a circle or sphere and connecting two points on the circumference. (NCI) A description of the quantity or quality of the hair or fur covering a biological entity. (NCI) The linear extent in space from one end of something to the other end, or the extent of something from beginning to end. (NCI) The spatial arrangement of something as distinct from its substance. (NCI) The formation or development of an ulcer. (NCI) The extent or measurement of something from side to side. (NCI) Color

NCI Preferred Term

C95110 C25333

Consistency Depth

Consistency Depth

Consistency Depth

C25365 C25285

Description Diameter

Description Diameter

Description Diameter

C95109 C25334

Hair Cover Length

Hair Cover Length

Hair or Fur Cover Length

C25677 C25757 C25345

Shape Ulceration Width

Shape Ulceration Width

Shape Ulceration Width

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 374 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C95121 - PHSPRPCD - Physical Properties Test Code Codelist extensible: Yes
CDISC Synonym Color

NCI Code C37927

CDISC Submission Value COLOR

CDISC Definition The appearance of objects (or light sources) described in terms of a person's perception of their hue and lightness (or brightness) and saturation. (NCI) A description about the firmness or make-up of an entity. The extent downward or inward; the perpendicular measurement from the surface downward to determine deepness. (NCI) A written or verbal account, representation, statement, or explanation of something. (NCI) The length of a straight line passing through the center of a circle or sphere and connecting two points on the circumference. (NCI) A description of the quantity or quality of the hair or fur covering a biological entity. (NCI) The linear extent in space from one end of something to the other end, or the extent of something from beginning to end. (NCI) The spatial arrangement of something as distinct from its substance. (NCI) The formation or development of an ulcer. (NCI) The extent or measurement of something from side to side. (NCI) Color

NCI Preferred Term

C95110 C25333

CONSIST DEPTH

Consistency Depth

Consistency Depth

C25365 C25285

DESCR DIAMETER

Description Diameter

Description Diameter

C95109 C25334

HAIRCOV LENGTH

Hair Cover Length

Hair or Fur Cover Length

C25677 C25757 C25345

SHAPE ULCER WIDTH

Shape Ulceration Width

Shape Ulceration Width

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 375 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AUC %Back Extrapolation Pred

NCI Code C85787

CDISC Submission Value AUC %Back Extrapolation Pred

CDISC Definition The percentage of the area under the curve (AUC) extrapolated to infinity that was due to back extrapolation to estimate concentration at time zero, based on the predicted value for concentration at time zero. This is only used for IV Bolus dosing. The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast. The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast. The area under the curve (AUC) from the time of dosing to the time of the last observation, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the body mass index, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the dose, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the surface area, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the weight, regardless of whether the last concentration is measurable or not.

NCI Preferred Term Predicted Area Under the Curve Percent Back Extrapolation

C85764

AUC %Extrapolation Obs

AUC %Extrapolation Obs AUC %Extrapolation Pred AUC All

Observed Area Under the Curve Percent Extrapolation Predicted Area Under the Curve Percent Extrapolation Area Under the Curve All

C85788

AUC %Extrapolation Pred

C85564

AUC All

C92362

AUC All Norm by BMI

AUC All Norm by BMI

AUC All Normalized by Body Mass Index

C92306

AUC All Norm by Dose

AUC All Norm by Dose

AUC All Normalized by Dose

C92307

AUC All Norm by SA

AUC All Norm by SA

AUC All Normalized by Surface Area

C92308

AUC All Norm by WT

AUC All Norm by WT

AUC All Normalized by Weight

C85761

AUC Infinity Obs

AUC Infinity Obs The area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by BMI to infinity divided by the body mass index. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by Dose to infinity divided by the dose.

Observed Area Under the Curve Infinity AUC Infinity Observed Normalized by Body Mass Index AUC Infinity Observed Normalized by Dose AUC Infinity Observed Normalized by Surface Area AUC Infinity Observed Normalized by Weight Predicted Area Under the Curve Infinity AUC Infinity Predicted Normalized by Body Mass Index

C92316 C96695 C92317 C92318 C85785

AUC Infinity Obs Norm by BMI AUC Infinity Obs Norm by Dose

AUC Infinity Obs Norm by SA AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by SA to infinity divided by the surface area. AUC Infinity Obs Norm by WT AUC Infinity Pred AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by WT to infinity divided by the weight. AUC Infinity Pred AUC Infinity Pred Norm by BMI The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the body mass index.

C92319

AUC Infinity Pred Norm by BMI

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 376 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AUC Infinity Pred Norm by Dose AUC Infinity Pred Norm by SA AUC Infinity Pred Norm by WT AUC Over Dosing Interval AUC Over Dosing Interval Norm by BMI AUC Over Dosing Interval Norm by Dose AUC Over Dosing Interval Norm by SA AUC Over Dosing Interval Norm by WT AUC from T1 to T2 AUC from T1 to T2 Norm by BMI AUC from T1 to T2 Norm by Dose AUC from T1 to T2 Norm by SA AUC from T1 to T2 Norm by WT AUC to Last Nonzero Conc AUC to Last Nonzero Conc Norm by BMI AUC to Last Nonzero Conc Norm by Dose AUC to Last Nonzero Conc Norm by SA AUC to Last Nonzero Conc Norm by WT

NCI Code C85786

CDISC Submission Value AUC Infinity Pred Norm by Dose AUC Infinity Pred Norm by SA AUC Infinity Pred Norm by WT AUC Over Dosing Interval AUC Over Dosing Interval Norm by BMI AUC Over Dosing Interval Norm by Dose AUC Over Dosing Interval Norm by SA AUC Over Dosing Interval Norm by WT AUC from T1 to T2 AUC from T1 to T2 Norm by BMI AUC from T1 to T2 Norm by Dose AUC from T1 to T2 Norm by SA AUC from T1 to T2 Norm by WT AUC to Last Nonzero Conc AUC to Last Nonzero Conc Norm by BMI AUC to Last Nonzero Conc Norm by Dose AUC to Last Nonzero Conc Norm by SA AUC to Last Nonzero Conc Norm by WT

CDISC Definition The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the dose. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the surface area. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the weight. The area under the curve (AUC) for the defined interval between doses (TAU). The area under the curve (AUC) for the defined interval between doses (TAU) divided by the body mass index. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the dose. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the surface area. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the weight. The area under the curve (AUC) over the interval from T1 to T2. The area under the curve (AUC) over the interval from T1 to T2 divided by the body mass index. The area under the curve (AUC) over the interval from T1 to T2 divided by the dose. The area under the curve (AUC) over the interval from T1 to T2 divided by the surface area. The area under the curve (AUC) over the interval from T1 to T2 divided by the weight. The area under the curve (AUC) from the time of dosing to the last measurable concentration. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the body mass index. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the dose. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the surface area. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the weight.

NCI Preferred Term Predicted Area Under the Curve Infinity by Dose AUC Infinity Predicted Normalized by Surface Area AUC Infinity Predicted Normalized by Weight Area Under the Curve Over Dosing Interval AUC Over Dosing Interval Normalized by Body Mass Index AUC Over Dosing Interval Normalized by Dose AUC Over Dosing Interval Normalized by Surface Area AUC Over Dosing Interval Normalized by Weight Area Under the Curve from T1 to T2 AUC from T1 to T2 Normalized by Body Mass Index AUC from T1 to T2 Normalized by Dose AUC from T1 to T2 Normalized by Surface Area AUC from T1 to T2 Normalized by Weight Area Under the Curve From Dosing to Last Concentration AUC Dosing to Last Concentration Normalized by Body Mass Index AUC Dosing to Last Concentration Normalized by Dose AUC Dosing to Last Concentration Normalized by Surface Area AUC Dosing to Last Concentration Normalized by Weight

C92320

C92321

C85567 C92322

C92323

C92324

C92325

C85566 C92312 C92313

C92314 C92315 C85565 C92309

C92310

C92311

C92305

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CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AUMC % Extrapolation Obs AUMC % Extrapolation Pred AUMC Infinity Obs AUMC Infinity Obs Norm by BMI AUMC Infinity Obs Norm by Dose AUMC Infinity Obs Norm by SA AUMC Infinity Obs Norm by WT AUMC Infinity Pred AUMC Infinity Pred Norm by BMI AUMC Infinity Pred Norm by Dose AUMC Infinity Pred Norm by SA AUMC Infinity Pred Norm by WT AUMC Over Dosing Interval AUMC Over Dosing Interval Norm by BMI AUMC Over Dosing Interval Norm by Dose AUMC Over Dosing Interval Norm by SA

NCI Code C85766

CDISC Submission Value AUMC % Extrapolation Obs

CDISC Definition The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast. The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the body mass index. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the dose. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the surface area. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the weight. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the body mass index. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the dose. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the surface area. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the weight. The area under the first moment curve (AUMC) for the defined interval between doses (TAU). The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the body mass index. The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the dose. The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the surface area.

NCI Preferred Term Observed Area Under the First Moment Curve Percent Extrapolation Predicted Area Under the First Moment Curve Percent Extrapolation Observed Area Under the First Moment Curve Infinity AUMC Infinity Observed Normalized by Body Mass Index AUMC Infinity Observed Normalized by Dose AUMC Infinity Observed Normalized by Surface Area AUMC Infinity Observed Normalized by Weight Predicted Area Under the First Moment Curve Infinity AUMC Infinity Predicted Normalized by Body Mass Index AUMC Infinity Predicted Normalized by Dose AUMC Infinity Predicted Normalized by Surface Area AUMC Infinity Predicted Normalized by Weight Area Under the First Moment Curve Over Dosing Interval AUMC Over Dosing Interval Normalized by Body Mass Index AUMC Over Dosing Interval Normalized by Dose AUMC Over Dosing Interval Normalized by Surface Area

C85790

AUMC % Extrapolation Pred

C85765

AUMC Infinity Obs

C92330

AUMC Infinity Obs Norm by BMI AUMC Infinity Obs Norm by Dose AUMC Infinity Obs Norm by SA AUMC Infinity Obs Norm by WT AUMC Infinity Pred

C92331

C92332

C92333

C85789

C92334

AUMC Infinity Pred Norm by BMI AUMC Infinity Pred Norm by Dose AUMC Infinity Pred Norm by SA AUMC Infinity Pred Norm by WT AUMC Over Dosing Interval AUMC Over Dosing Interval Norm by BMI AUMC Over Dosing Interval Norm by Dose AUMC Over Dosing Interval Norm by SA

C92335

C92336

C92337

C85570 C92338

C92339

C92340

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 378 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AUMC Over Dosing Interval Norm by WT AUMC to Last Nonzero Conc AUMC to Last Nonzero Conc Norm by BMI AUMC to Last Nonzero Conc Norm by Dose AUMC to Last Nonzero Conc Norm by SA AUMC to Last Nonzero Conc Norm by WT AURC % Extrapolation Obs AURC % Extrapolation Pred AURC All AURC All Norm by BMI AURC All Norm by Dose AURC All Norm by SA AURC All Norm by WT AURC to Last Nonzero Rate AURC to Last Nonzero Rate Norm by BMI AURC to Last Nonzero Rate Norm by Dose

NCI Code C92341

CDISC Submission Value AUMC Over Dosing Interval Norm by WT AUMC to Last Nonzero Conc AUMC to Last Nonzero Conc Norm by BMI AUMC to Last Nonzero Conc Norm by Dose AUMC to Last Nonzero Conc Norm by SA AUMC to Last Nonzero Conc Norm by WT AURC % Extrapolation Obs

CDISC Definition The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the weight. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the body mass index. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the dose. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the surface area. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the weight. The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity observed from Tlast to infinity. The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity predicted from Tlast to infinity. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the body mass index. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the dose. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the surface area. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the weight. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the body mass index. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the dose.

NCI Preferred Term AUMC Over Dosing Interval Normalized by Weight Area Under the First Moment Curve From Dosing to Last Concentration AUMC Dosing to Last Concentration Normalized by Body Mass Index AUMC Dosing to Last Concentration Normalized by Dose AUMC Dosing to Last Concentration Normalized by Surface Area AUMC Dosing to Last Concentration Normalized by Weight Observed Area Under the Urinary Excretion Rate Curve Percent Extrapolation Predicted Area Under the Urinary Excretion Rate Curve Percent Extrapolation Area Under Urinary Excretion Rate Curve All AURC All Normalized by Body Mass Index AURC All Normalized by Dose

C85569 C92326

C92327

C92328

C92329

C85768

C85792

AURC % Extrapolation Pred

C85841 C92342

AURC All AURC All Norm by BMI

C92343

AURC All Norm by Dose

C92344

AURC All Norm by SA

AURC All Normalized by Surface Area AURC All Normalized by Weight

C92345

AURC All Norm by WT

C85571

AURC Dosing to Last Conc

Area Under the Urinary Excretion Rate Curve From Dosing to Last Concentration AURC Dosing to Last Concentration Normalized by Body Mass Index AURC Dosing to Last Concentration Normalized by Dose

C92346

AURC Dosing to Last Conc Norm by BMI AURC Dosing to Last Conc Norm by Dose

C92347

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 379 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AURC to Last Nonzero Rate Norm by SA AURC to Last Nonzero Rate Norm by WT AURC Infinity Obs AURC Infinity Obs Norm by BMI AURC Infinity Obs Norm by Dose AURC Infinity Obs Norm by SA AURC Infinity Obs Norm by WT AURC Infinity Pred AURC Infinity Pred Norm by BMI AURC Infinity Pred Norm by Dose AURC Infinity Pred Norm by SA AURC Infinity Pred Norm by WT AURC from T1 to T2 AURC from T1 to T2 Norm by BMI AURC from T1 to T2 Norm by Dose AURC from T1 to T2 Norm by SA

NCI Code C92348

CDISC Submission Value AURC Dosing to Last Conc Norm by SA AURC Dosing to Last Conc Norm by WT AURC Infinity Obs

CDISC Definition The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the weight. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the body mass index. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the dose. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the weight. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the body mass index. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the dose. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the weight. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the body mass index. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the dose. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the surface area.

NCI Preferred Term AURC Dosing to Last Concentration Normalized by Surface Area AURC Dosing to Last Concentration Normalized by Weight Observed Area Under the Urinary Excretion Rate Curve infinity AURC Infinity Observed Normalized by Body Mass Index

C92349

C85767

C92354

AURC Infinity Obs Norm by BMI

C92355

AURC Infinity Obs Norm by Dose AURC Infinity Obs Norm by SA AURC Infinity Obs Norm by WT AURC Infinity Pred

AURC Infinity Observed Normalized by Dose AURC Infinity Observed Normalized by Surface Area AURC Infinity Observed Normalized by Weight Predicted Area Under the Urinary Excretion Rate Curve Infinity AURC Infinity Predicted Normalized by Body Mass Index

C92356

C92357

C85791

C92358

AURC Infinity Pred Norm by BMI

C92359

AURC Infinity Pred Norm by Dose AURC Infinity Pred Norm by SA AURC Infinity Pred Norm by WT AURC from T1 to T2 AURC from T1 to T2 Norm by BMI AURC from T1 to T2 Norm by Dose AURC from T1 to T2 Norm by SA

AURC Infinity Predicted Normalized by Dose AURC Infinity Predicted Normalized by Surface Area AURC Infinity Predicted Normalized by Weight Area Under the Urinary Excretion Rate Curve from T1 to T2 AURC from T1 to T2 Normalized by Body Mass Index AURC from T1 to T2 Normalized by Dose AURC from T1 to T2 Normalized by Surface Area

C92360

C92361

C85572 C92350

C92351

C92352

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 380 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym AURC from T1 to T2 Norm by WT Accumulation Ratio AUC Accumulation Ratio Cmax Accumulation Ratio Cmin Accumulation Ratio Ctrough Amt Rec Over Dosing Interval Amt Rec Over Dosing Interval Norm by BMI Amt Rec Over Dosing Interval Norm by SA Amt Rec Over Dosing Interval Norm by WT Amt Rec from T1 to T2 Amt Rec from T1 to T2 Norm by BMI Amt Rec from T1 to T2 Norm by SA Amt Rec from T1 to T2 Norm by WT Average Conc; Average Concentration Average Conc Norm by BMI Average Conc Norm by Dose Average Conc Norm by SA Average Conc Norm by WT

NCI Code C92353

CDISC Submission Value AURC from T1 to T2 Norm by WT Accumulation Ratio AUC

CDISC Definition The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the weight. The area under the curve (AUCTAU) at steady state divided by the area under the curve over the initial dosing interval. The maximum concentration at steady state divided by the maximum concentration during the initial dosing interval. The minimum concentration at steady state divided by the minimum concentration during the initial dosing interval. The trough concentration at steady state divided by the trough concentration during the initial dosing interval. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU). The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by body mass index. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by surface area. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by weight. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by body mass index. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by surface area. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by weight. AUCTAU divided by TAU.

NCI Preferred Term AURC from T1 to T2 Normalized by Weight Accumulation Ratio Area Under the Curve Accumulation Ratio Cmax

C102356

C102357

Accumulation Ratio Cmax

C102358

Accumulation Ratio Cmin

Accumulation Ratio Cmin

C102426 C102363 C102364

Accumulation Ratio Ctrough Amt Rec Over Dosing Interval Amt Rec Over Dosing Interval Norm by BMI Amt Rec Over Dosing Interval Norm by SA Amt Rec Over Dosing Interval Norm by WT Amt Rec from T1 to T2

Accumulation Ratio Ctrough Amount Recovered Over Dosing Interval Amount Recovered Over Dosing Interval Normalized by Body Mass Index Amount Recovered Over Dosing Interval Normalized by Surface Area Amount Recovered Over Dosing Interval Normalized by Weight Amount Recovered from T1 to T2

C102365

C102366

C102359

C102360

Amt Rec from T1 to T2 Norm by BMI Amt Rec from T1 to T2 Norm by SA Amt Rec from T1 to T2 Norm by WT Average Conc

Amount Recovered from T1 to T2 Normalized by Body Mass Index Amount Recovered from T1 to T2 Normalized by Surface Area Amount Recovered from T1 to T2 Normalized by Weight Average Concentration

C102361

C102362

C85575

C92367 C92368 C92369 C92370

Average Conc Norm by BMI Average Conc Norm by Dose Average Conc Norm by SA Average Conc Norm by WT

AUCTAU divided by TAU and then divided by the body Average Concentration Normalized mass index. by Body Mass Index AUCTAU divided by TAU and then divided by the dose. Average Concentration Normalized by Dose AUCTAU divided by TAU and then divided by the surface area. AUCTAU divided by TAU and then divided by the weight. Average Concentration Normalized by Surface Area Average Concentration Normalized by Weight

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 381 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Conc Conc Trough Conc Trough by BMI Conc Trough by Dose Conc Trough by SA Conc Trough by WT Conc by BMI Conc by Dose Conc by SA Conc by WT Correlation Between TimeX and Log ConcY Effective Half-Life Fluctuation% Half-Life Lambda z Initial Conc Initial Conc Norm by BMI Initial Conc Norm by Dose Initial Conc Norm by SA Initial Conc Norm by WT Lambda z Lambda z Lower Limit Lambda z Upper Limit Last Meas Excretion Rate

NCI Code C41185 C102394 C102395 C102396 C102397 C102398 C102367 C102368 C102369 C102370 C85821

CDISC Submission Value Conc Conc Trough Conc Trough by BMI Conc Trough by Dose Conc Trough by SA Conc Trough by WT Conc by BMI Conc by Dose Conc by SA Conc by WT Correlation Between TimeX and Log ConcY Effective Half-Life Fluctuation% Half-Life Lambda z Initial Conc Initial Conc Norm by BMI Initial Conc Norm by Dose Initial Conc Norm by SA Initial Conc Norm by WT Lambda z Lambda z Lower Limit Lambda z Upper Limit Last Meas Excretion Rate

CDISC Definition The quantity of a specified substance in a unit volume or weight of another substance. Concentration at end of dosing interval. The trough concentration divided by body mass index. The trough concentration divided by dose. The trough concentration divided by surface area. The trough concentration divided by weight. The concentration divided by body mass index. The concentration divided by dose. The concentration divided by surface area. The concentration divided by weight. The correlation between time (X) and log concentration (Y) for the points used in the estimation of lambda z. The drug half-life that quantifies the accumulation ratio of a drug following multiple dosing. The difference between Cmin and Cmax standardized to Cavg, between dose time and Tau. Terminal half-life. Initial concentration. Given only for bolus IV models. Initial concentration divided by the body mass index. Given only for bolus IV models. Initial concentration divided by the dose. Given only for bolus IV models. Initial concentration divided by the surface area. Given only for bolus IV models. Initial concentration divided by the weight. Given only for bolus IV models. The first order rate constant associated with the terminal (log-linear) portion of the curve. The lower limit on time for values to be included in the calculation of Lambda z. The upper limit on time for values to be included in the calculation of Lambda z. The last measurable (positive) excretion rate.

NCI Preferred Term Concentration Trough Concentration Trough Concentration Divided by Body Mass Index Trough Concentration Divided by Dose Trough Concentration Divided by Surface Area Trough Concentration Divided by Weight Concentration Divided by Body Mass Index Concentration Divided by Dose Concentration Divided by Surface Area Concentration Divided by Weight Time and Log Concentration Correlation Effective Half-life Concentration Variability Between Dose Time and Tau Terminal Half Life Initial Concentration Initial Concentration Normalized by Body Mass Index Initial Concentration Normalized by Dose Initial Concentration Normalized by Surface Area Initial Concentration Normalized by Weight Lambda Z Lambda Z Time Lower Limit Lambda Z Time Upper Limit Last Measurable Observed Excretion Rate

C95007 C85581 C85818 C85644 C92383 C92384 C92385 C92386 C85652 C85653 C85654 C85656

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 382 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Last Meas Excretion Rate Norm by BMI Last Meas Excretion Rate Norm by Dose Last Meas Excretion Rate Norm by SA Last Meas Excretion Rate Norm by WT Last Nonzero Conc Last Nonzero Conc Norm by BMI Last Nonzero Conc Norm by Dose Last Nonzero Conc Norm by SA Last Nonzero Conc Norm by WT MRT Infinity Obs MRT Infinity Pred MRT to Last Nonzero Conc Max Conc Max Conc Norm by BMI Max Conc Norm by Dose Max Conc Norm by SA Max Conc Norm by WT Max Obs Excretion Rate Max Obs Excretion Rate Norm by BMI

NCI Code C92391

CDISC Submission Value Last Meas Excretion Rate Norm by BMI Last Meas Excretion Rate Norm by Dose Last Meas Excretion Rate Norm by SA Last Meas Excretion Rate Norm by WT Last Nonzero Conc Last Nonzero Conc Norm by BMI Last Nonzero Conc Norm by Dose Last Nonzero Conc Norm by SA Last Nonzero Conc Norm by WT MRT Infinity Obs MRT Infinity Pred MRT to Last Nonzero Conc Max Conc Max Conc Norm by BMI Max Conc Norm by Dose Max Conc Norm by SA Max Conc Norm by WT Max Obs Excretion Rate Max Obs Excretion Rate Norm by BMI

CDISC Definition The last measurable (positive) excretion rate divided by the body mass index. The last measurable (positive) excretion rate divided by the dose. The last measurable (positive) excretion rate divided by the surface area. The last measurable (positive) excretion rate divided by the weight. The concentration corresponding to Tlast. The concentration corresponding to Tlast divided by the body mass index. The concentration corresponding to Tlast divided by the dose. The concentration corresponding to Tlast divided by the surface area. The concentration corresponding to Tlast divided by the weight. The observed mean residence time (MRT) extrapolated to infinity. The predicted mean residence time (MRT) extrapolated to infinity. Mean residence time (MRT) from the time of dosing to the time of the last measurable concentration. The maximum concentration occurring at Tmax. The maximum concentration occurring at Tmax, divided by the body mass index. The maximum concentration occurring at Tmax, divided by the dose. The maximum concentration occurring at Tmax, divided by the surface area. The maximum concentration occurring at Tmax, divided by the weight. The maximum observed excretion rate. The maximum observed excretion rate divided by the body mass index.

NCI Preferred Term Last Measurable Excretion Rate Normalized by Body Mass Index Last Measurable Excretion Rate Normalized by Dose Last Measurable Excretion Rate Normalized by Surface Area Last Measurable Excretion Rate Normalized by Weight Last Concentration Last Concentration Normalized by Body Mass Index Last Concentration Normalized by Dose Last Concentration Normalized by Surface Area Last Concentration Normalized by Weight Observed Mean Residence Time Infinity Predicted Mean Residence Time Infinity Mean Residence Time Last Cmax Maximum Concentration Normalized by Body Mass Index Maximum Concentration Dose Normalized Maximum Concentration Normalized by Surface Area Maximum Concentration Normalized by Weight Maximum Observed Excretion Rate Maximum Observed Excretion Rate Normalized by Body Mass Index

C92392

C92393

C92394

C85655 C92387

C92388

C92389

C92390

C85769 C85793 C85700 C70918 C92371 C85698 C92372 C92373 C85699 C92395

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 383 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Max Obs Excretion Rate Norm by Dose Max Obs Excretion Rate Norm by SA Max Obs Excretion Rate Norm by WT Midpoint of Collection Interval Min Conc Min Conc Norm by BMI Min Conc Norm by Dose Min Conc Norm by SA Min Conc Norm by WT Nonrenal CL Number of Points for Lambda z Pct Rec Over Dosing Interval Pct Rec Over Dosing Interval Norm by BMI Pct Rec Over Dosing Interval Norm by SA Pct Rec Over Dosing Interval Norm by WT Pct Rec from T1 to T2

NCI Code C92396

CDISC Submission Value Max Obs Excretion Rate Norm by Dose Max Obs Excretion Rate Norm by SA Max Obs Excretion Rate Norm by WT Midpoint of Collection Interval Min Conc Min Conc Norm by BMI

CDISC Definition The maximum observed excretion rate divided by the dose. The maximum observed excretion rate divided by the surface area. The maximum observed excretion rate divided by the weight. The midpoint of collection interval, which is associated with last Measurable rate. The minimum concentration between dose time and dose time plus Tau (at Tmin). The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the body mass index. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the dose. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the surface area. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the weight. The total clearance of a substance from the blood less the renal clearance. The number of time points used in computing Lambda z. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU). The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by the body mass index. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by surface area. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by weight. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2.

NCI Preferred Term Maximum Observed Excretion Rate Normalized by Dose Maximum Observed Excretion Rate Normalized by Surface Area Maximum Observed Excretion Rate Normalized by Weight Collection Interval Midpoint

C92397

C92398

C85580

C85579 C92374

Cmin Minimum Concentration Normalized by Body Mass Index Minimum Concentration Normalized by Dose Minimum Concentration Normalized by Surface Area Minimum Concentration Normalized by Weight Nonrenal Clearance Sum of Lambda Z Timepoints

C92375 C92376

Min Conc Norm by Dose Min Conc Norm by SA

C92377 C102376 C85816

Min Conc Norm by WT Nonrenal CL Number of Points for Lambda z Pct Rec Over Dosing Interval

C102386

Percent Recovered Over Dosing Interval Percent Recovered Over Dosing Interval Normalized by Body Mass Index Percent Recovered Over Dosing Interval Normalized by Surface Area

C102387

Pct Rec Over Dosing Interval Norm by BMI

C102388

Pct Rec Over Dosing Interval Norm by SA

C102389

Pct Rec Over Dosing Interval Norm by WT Pct Rec from T1 to T2

Percent Recovered Over Dosing Interval Normalized by Weight Percent Recovered from T1 to T2

C102382

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 384 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Pct Rec from T1 to T2 Norm by BMI Pct Rec from T1 to T2 Norm by SA Pct Rec from T1 to T2 Norm by WT Peak Trough Ratio R Squared R Squared Adjusted Renal CL Sum of Urine Vol Time Until First Nonzero Conc Time of CMAX Time of CMIN Observation Time of Last Nonzero Conc Time of Max Excretion Rate Total CL Obs Total CL Obs Norm by BMI Total CL Obs Norm by SA Total CL Obs Norm by WT Total CL Obs by F; Total CL Obs by Fraction Dose (Bioavailability)

NCI Code C102383

CDISC Submission Value Pct Rec from T1 to T2 Norm by BMI

CDISC Definition The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by body mass index. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by surface area. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by weight. The ratio of Cmax to Ctrough during a dosing interval. The goodness of fit statistic for the terminal elimination phase. The goodness of fit statistic for the terminal elimination phase, adjusted for the number of time points used in the estimation of Lambda z. The clearance of a substance from the blood by the kidneys. The sum of urine volumes that are used for PK parameters. The time prior to the first measurable (non-zero) concentration. The time of maximum observed concentration sampled during a dosing interval. The time of minimum concentration sampled during a dosing interval. The time of the last measurable (positive) concentration. The midpoint of collection interval associated with the maximum observed excretion rate. The observed total body clearance for intravascular administration. The observed total body clearance for intravascular administration divided by the body mass index. The observed total body clearance for intravascular administration divided by the surface area. The observed total body clearance for intravascular administration divided by the weight. The observed total body clearance for extravascular administration based on the fraction of dose absorbed.

NCI Preferred Term Percent Recovered from T1 to T2 Normalized by Body Mass Index

C102384

Pct Rec from T1 to T2 Norm by SA

Percent Recovered from T1 to T2 Normalized by Surface Area

C102385

Pct Rec from T1 to T2 Norm by WT

Percent Recovered from T1 to T2 Normalized by Weight

C102381 C85542 C85553

Peak Trough Ratio R Squared R Squared Adjusted

Peak Trough Ratio R Squared Adjusted R Squared

C75913 C85817 C85824 C70919 C85825 C85822 C85823 C85773 C92403 C92405 C92406 C85772

Renal CL Sum of Urine Vol Time Until First Nonzero Conc Time of CMAX Time of CMIN Observation Time of Last Nonzero Conc Time of Max Excretion Rate Total CL Obs Total CL Obs Norm by BMI Total CL Obs Norm by SA Total CL Obs Norm by WT Total CL Obs by F

Renal Clearance Sum Urine Volume Time until First Nonzero Concentration Tmax Tmin Time of Last Nonzero Concentration Time of Maximum Observed Excretion Rate Observed Total Body Clearance Rate Total Clearance Observed Normalized by Body Mass Index Total Clearance Observed Normalized by Surface Area Total Clearance Observed Normalized by Weight Observed Total Body Clearance by Fraction of Dose Absorbed

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 385 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Total CL Obs by Fract Dose Norm by BMI Total CL Obs by Fract Dose Norm by SA Total CL Obs by Fract Dose Norm by WT Total CL Pred Total CL Pred Norm by BMI Total CL Pred Norm by SA Total CL Pred Norm by WT Total CL Pred by Fract Dose Total CL Pred by Fract Dose Norm by BMI Total CL Pred by Fract Dose Norm by SA Total CL Pred by Fract Dose Norm by WT Vol Dist Initial Vol Dist Initial Norm by BMI Vol Dist Initial Norm by Dose Vol Dist Initial Norm by SA Vol Dist Initial Norm by WT Vol Dist Steady State Obs Vol Dist Steady State Obs Norm by BMI

NCI Code C92399

CDISC Submission Value Total CL Obs by Fract Dose Norm by BMI Total CL Obs by Fract Dose Norm by SA Total CL Obs by Fract Dose Norm by WT Total CL Pred Total CL Pred Norm by BMI Total CL Pred Norm by SA Total CL Pred Norm by WT Total CL Pred by Fract Dose Total CL Pred by Fract Dose Norm by BMI Total CL Pred by Fract Dose Norm by SA Total CL Pred by Fract Dose Norm by WT Vol Dist Initial Vol Dist Initial Norm by BMI

CDISC Definition The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index. The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area. The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight. The predicted total body clearance for intravascular administration. The predicted total body clearance for intravascular administration divided by the body mass index. The predicted total body clearance for intravascular administration divided by the surface area. The predicted total body clearance for intravascular administration divided by the weight. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight. The initial volume of distribution for a substance administered by bolus intravascular dosing. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the body mass index. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the dose. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the surface area. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the weight. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the body mass index.

NCI Preferred Term Total Clearance Observed by Fraction Dose Normalized by Body Mass Index Total Clearance Observed by Fraction Dose Normalized by Surface Area Total Clearance Observed by Fraction Dose Normalized by Weight Predicted Total Body Clearance Rate Total Clearance Predicted Normalized by Body Mass Index Total Clearance Predicted Normalized by Surface Area Total Clearance Predicted Normalized by Weight Predicted Total Body Clearance by Fraction of Dose Absorbed Total Clearance Predicted by Fraction Dose Normalized by Body Mass Index Total Clearance Predicted by Fraction Dose Normalized by Surface Area Total Clearance Predicted by Fraction Dose Normalized by Weight Initial Volume of Distribution Initial Volume of Distribution Normalized by Body Mass Index Initial Volume of Distribution Normalized by Dose Initial Volume of Distribution Normalized by Surface Area Initial Volume of Distribution Normalized by Weight Observed Steady State Volume of Distribution Observed Steady State Volume of Distribution Normalized by Body Mass Index

C92401

C92402

C85797 C92421 C92423 C92424 C85796 C92417

C92419

C92420

C102371 C102372

C102373

Vol Dist Initial Norm by Dose

C102374

Vol Dist Initial Norm by SA

C102375

Vol Dist Initial Norm by WT

C85770

Vol Dist Steady State Obs

C102377

Vol Dist Steady State Obs Norm by BMI

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 386 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Vol Dist Steady State Obs Norm by Dose Vol Dist Steady State Obs Norm by SA Vol Dist Steady State Obs Norm by WT Vol Dist Steady State Pred Vol Dist Steady State Pred Norm by BMI Vol Dist Steady State Pred Norm by Dose Vol Dist Steady State Pred Norm by SA Vol Dist Steady State Pred Norm by WT Vol Dist of Fract Dose Obs

NCI Code C102378

CDISC Submission Value Vol Dist Steady State Obs Norm by Dose Vol Dist Steady State Obs Norm by SA Vol Dist Steady State Obs Norm by WT Vol Dist Steady State Pred

CDISC Definition The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the dose. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the surface area. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the weight. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the body mass index. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the dose. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the surface area. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the weight. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index.

NCI Preferred Term Observed Steady State Volume of Distribution Normalized by Dose Observed Steady State Volume of Distribution Normalized by Surface Area Observed Steady State Volume of Distribution Normalized by Weight Predicted Steady State Volume of Distribution Predicted Steady State Volume of Distribution Normalized by Body Mass Index Predicted Steady State Volume of Distribution Normalized by Dose Predicted Steady State Volume of Distribution Normalized by Surface Area Predicted Steady State Volume of Distribution Normalized by Weight Observed Volume of Distribution of Absorbed Fraction

C102379

C102380

C85794

C102390

Vol Dist Steady State Pred Norm by BMI Vol Dist Steady State Pred Norm by Dose Vol Dist Steady State Pred Norm by SA Vol Dist Steady State Pred Norm by WT Vol Dist of Fract Dose Obs

C102391

C102392

C102393

C85775

C92410

Vol Dist of Fract Dose Obs Norm by BMI

Vol Dist of Fract Dose Obs Norm by BMI

Volume of Distribution of Fraction Dose Observed Normalized by Body Mass Index

C92411

Vol Dist of Fract Dose Obs Norm by SA

Vol Dist of Fract Dose Obs Norm by SA Vol Dist of Fract Dose Obs Norm by WT Vol Dist of Fract Dose Pred

Volume of Distribution of Fraction Dose Observed Normalized by Surface Area Volume of Distribution of Fraction Dose Observed Normalized by Weight Predicted Volume of Distribution of Absorbed Fraction

C92412

Vol Dist of Fract Dose Obs Norm by WT

C85799

Vol Dist of Fract Dose Pred

C92428

Vol Dist of Fract Dose Pred Norm by BMI

Vol Dist of Fract Dose Pred Norm by BMI

Volume of Distribution of Fraction Dose Predicted Normalized by Body Mass Index

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 387 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85493 - PKPARM - PK Parameters Codelist extensible: Yes
CDISC Synonym Vol Dist of Fract Dose Pred Norm by SA Vol Dist of Fract Dose Pred Norm by WT Vz Obs

NCI Code C92429

CDISC Submission Value Vol Dist of Fract Dose Pred Norm by SA

CDISC Definition The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight. The observed volume of distribution associated with the terminal slope following intravascular administration. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the surface area. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the weight. The predicted volume of distribution associated with the terminal slope following intravascular administration. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the surface area. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the weight.

NCI Preferred Term Volume of Distribution of Fraction Dose Predicted Normalized by Surface Area Volume of Distribution of Fraction Dose Predicted Normalized by Weight Observed Volume of Distribution

C92430

Vol Dist of Fract Dose Pred Norm by WT

C85774

Vz Obs

C92407

Vz Obs Norm by BMI

Vz Obs Norm by BMI Vz Obs Norm by SA Vz Obs Norm by WT Vz Pred

Volume of Distribution Observed Normalized by Body Mass Index Volume of Distribution Observed Normalized by Surface Area Volume of Distribution Observed Normalized by Weight Predicted Volume of Distribution

C92408

Vz Obs Norm by SA

C92409

Vz Obs Norm by WT

C85798

Vz Pred

C92425

Vz Pred Norm by BMI

Vz Pred Norm by BMI Vz Pred Norm by SA Vz Pred Norm by WT

Volume of Distribution Predicted Normalized by Body Mass Index Volume of Distribution Predicted Normalized by Surface Area Volume of Distribution Predicted Normalized by Weight

C92426

Vz Pred Norm by SA

C92427

Vz Pred Norm by WT

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 388 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Accumulation Ratio AUC Accumulation Ratio Cmax Accumulation Ratio Cmin Accumulation Ratio Ctrough AUC All

NCI Code C102356

CDISC Submission Value ARAUC

CDISC Definition The area under the curve (AUCTAU) at steady state divided by the area under the curve over the initial dosing interval. The maximum concentration at steady state divided by the maximum concentration during the initial dosing interval. The minimum concentration at steady state divided by the minimum concentration during the initial dosing interval. The trough concentration at steady state divided by the trough concentration during the initial dosing interval. The area under the curve (AUC) from the time of dosing to the time of the last observation, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the body mass index, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the dose, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the surface area, regardless of whether the last concentration is measurable or not. The area under the curve (AUC) from the time of dosing to the time of the last observation divided by the weight, regardless of whether the last concentration is measurable or not.

NCI Preferred Term Accumulation Ratio Area Under the Curve Accumulation Ratio Cmax

C102357

ARCMAX

C102358

ARCMIN

Accumulation Ratio Cmin

C102426 C85564

ARCTROUG AUCALL

Accumulation Ratio Ctrough Area Under the Curve All

C92362

AUCALLB

AUC All Norm by BMI

AUC All Normalized by Body Mass Index

C92306

AUCALLD

AUC All Norm by Dose

AUC All Normalized by Dose

C92307

AUCALLS

AUC All Norm by SA

AUC All Normalized by Surface Area

C92308

AUCALLW

AUC All Norm by WT

AUC All Normalized by Weight

C85761

AUCIFO

AUC Infinity Obs The area under the curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by BMI to infinity divided by the body mass index. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by Dose to infinity divided by the dose. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by SA to infinity divided by the surface area. AUC Infinity Obs The observed area under the curve (AUC) extrapolated Norm by WT to infinity divided by the weight. AUC Infinity Pred AUC Infinity Pred Norm by BMI The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the body mass index.

Observed Area Under the Curve Infinity AUC Infinity Observed Normalized by Body Mass Index AUC Infinity Observed Normalized by Dose AUC Infinity Observed Normalized by Surface Area AUC Infinity Observed Normalized by Weight Predicted Area Under the Curve Infinity AUC Infinity Predicted Normalized by Body Mass Index

C92316 C96695 C92317 C92318 C85785

AUCIFOB AUCIFOD AUCIFOS AUCIFOW AUCIFP

C92319

AUCIFPB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 389 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym AUC Infinity Pred Norm by Dose AUC Infinity Pred Norm by SA AUC Infinity Pred Norm by WT AUC from T1 to T2 AUC from T1 to T2 Norm by BMI AUC from T1 to T2 Norm by Dose AUC from T1 to T2 Norm by SA AUC from T1 to T2 Norm by WT AUC to Last Nonzero Conc AUC to Last Nonzero Conc Norm by BMI AUC to Last Nonzero Conc Norm by Dose AUC to Last Nonzero Conc Norm by SA AUC to Last Nonzero Conc Norm by WT AUC %Back Extrapolation Pred

NCI Code C85786

CDISC Submission Value AUCIFPD

CDISC Definition The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the dose. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the surface area. The area under the curve (AUC) extrapolated to infinity from dosing time, based on the predicted last concentration, divided by the weight. The area under the curve (AUC) over the interval from T1 to T2. The area under the curve (AUC) over the interval from T1 to T2 divided by the body mass index. The area under the curve (AUC) over the interval from T1 to T2 divided by the dose. The area under the curve (AUC) over the interval from T1 to T2 divided by the surface area. The area under the curve (AUC) over the interval from T1 to T2 divided by the weight. The area under the curve (AUC) from the time of dosing to the last measurable concentration. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the body mass index. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the dose. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the surface area. The area under the curve (AUC) from the time of dosing to the last measurable concentration divided by the weight. The percentage of the area under the curve (AUC) extrapolated to infinity that was due to back extrapolation to estimate concentration at time zero, based on the predicted value for concentration at time zero. This is only used for IV Bolus dosing. The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast. The percentage of the area under the curve (AUC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast. The area under the curve (AUC) for the defined interval between doses (TAU).

NCI Preferred Term Predicted Area Under the Curve Infinity by Dose AUC Infinity Predicted Normalized by Surface Area AUC Infinity Predicted Normalized by Weight Area Under the Curve from T1 to T2 AUC from T1 to T2 Normalized by Body Mass Index AUC from T1 to T2 Normalized by Dose AUC from T1 to T2 Normalized by Surface Area AUC from T1 to T2 Normalized by Weight Area Under the Curve From Dosing to Last Concentration AUC Dosing to Last Concentration Normalized by Body Mass Index AUC Dosing to Last Concentration Normalized by Dose AUC Dosing to Last Concentration Normalized by Surface Area AUC Dosing to Last Concentration Normalized by Weight Predicted Area Under the Curve Percent Back Extrapolation

C92320

AUCIFPS

C92321

AUCIFPW

C85566 C92312 C92313

AUCINT AUCINTB AUCINTD

C92314 C92315 C85565 C92309

AUCINTS AUCINTW AUCLST AUCLSTB

C92310

AUCLSTD

C92311

AUCLSTS

C92305

AUCLSTW

C85787

AUCPBEP

C85764

AUCPEO

AUC %Extrapolation Obs AUC %Extrapolation Pred AUC Over Dosing Interval

Observed Area Under the Curve Percent Extrapolation Predicted Area Under the Curve Percent Extrapolation Area Under the Curve Over Dosing Interval

C85788

AUCPEP

C85567

AUCTAU

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 390 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym AUC Over Dosing Interval Norm by BMI AUC Over Dosing Interval Norm by Dose AUC Over Dosing Interval Norm by SA AUC Over Dosing Interval Norm by WT AUMC Infinity Obs AUMC Infinity Obs Norm by BMI AUMC Infinity Obs Norm by Dose AUMC Infinity Obs Norm by SA AUMC Infinity Obs Norm by WT AUMC Infinity Pred AUMC Infinity Pred Norm by BMI AUMC Infinity Pred Norm by Dose AUMC Infinity Pred Norm by SA AUMC Infinity Pred Norm by WT AUMC to Last Nonzero Conc AUMC to Last Nonzero Conc Norm by BMI

NCI Code C92322

CDISC Submission Value AUCTAUB

CDISC Definition The area under the curve (AUC) for the defined interval between doses (TAU) divided by the body mass index. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the dose. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the surface area. The area under the curve (AUC) for the defined interval between doses (TAU) divided by the weight. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the body mass index. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the dose. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the surface area. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last observed concentration divided by the weight. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the body mass index. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the dose. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the surface area. The area under the first moment curve (AUMC) extrapolated to infinity, based on the last predicted concentration divided by the weight. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the body mass index.

NCI Preferred Term AUC Over Dosing Interval Normalized by Body Mass Index AUC Over Dosing Interval Normalized by Dose AUC Over Dosing Interval Normalized by Surface Area AUC Over Dosing Interval Normalized by Weight Observed Area Under the First Moment Curve Infinity AUMC Infinity Observed Normalized by Body Mass Index AUMC Infinity Observed Normalized by Dose AUMC Infinity Observed Normalized by Surface Area AUMC Infinity Observed Normalized by Weight Predicted Area Under the First Moment Curve Infinity AUMC Infinity Predicted Normalized by Body Mass Index AUMC Infinity Predicted Normalized by Dose AUMC Infinity Predicted Normalized by Surface Area AUMC Infinity Predicted Normalized by Weight Area Under the First Moment Curve From Dosing to Last Concentration AUMC Dosing to Last Concentration Normalized by Body Mass Index

C92323

AUCTAUD

C92324

AUCTAUS

C92325

AUCTAUW

C85765

AUMCIFO

C92330

AUMCIFOB

C92331

AUMCIFOD

C92332

AUMCIFOS

C92333

AUMCIFOW

C85789

AUMCIFP

C92334

AUMCIFPB

C92335

AUMCIFPD

C92336

AUMCIFPS

C92337

AUMCIFPW

C85569 C92326

AUMCLST AUMCLSTB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 391 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym AUMC to Last Nonzero Conc Norm by Dose AUMC to Last Nonzero Conc Norm by SA AUMC to Last Nonzero Conc Norm by WT AUMC % Extrapolation Obs AUMC % Extrapolation Pred AUMC Over Dosing Interval AUMC Over Dosing Interval Norm by BMI AUMC Over Dosing Interval Norm by Dose AUMC Over Dosing Interval Norm by SA AUMC Over Dosing Interval Norm by WT AURC All AURC All Norm by BMI AURC All Norm by Dose AURC All Norm by SA AURC All Norm by WT AURC Infinity Obs

NCI Code C92327

CDISC Submission Value AUMCLSTD

CDISC Definition The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the dose. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the surface area. The area under the moment curve (AUMC) from the time of dosing to the last measurable concentration divided by the weight. The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the observed value for concentration at TLast. The percentage of the area under the moment curve (AUMC) extrapolated to infinity from Tlast to infinity based on the predicted value for concentration at TLast. The area under the first moment curve (AUMC) for the defined interval between doses (TAU). The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the body mass index. The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the dose. The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the surface area. The area under the first moment curve (AUMC) for the defined interval between doses (TAU) divided by the weight. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the body mass index. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the dose. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the surface area. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate divided by the weight. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate.

NCI Preferred Term AUMC Dosing to Last Concentration Normalized by Dose AUMC Dosing to Last Concentration Normalized by Surface Area AUMC Dosing to Last Concentration Normalized by Weight Observed Area Under the First Moment Curve Percent Extrapolation Predicted Area Under the First Moment Curve Percent Extrapolation Area Under the First Moment Curve Over Dosing Interval AUMC Over Dosing Interval Normalized by Body Mass Index AUMC Over Dosing Interval Normalized by Dose AUMC Over Dosing Interval Normalized by Surface Area AUMC Over Dosing Interval Normalized by Weight Area Under Urinary Excretion Rate Curve All AURC All Normalized by Body Mass Index AURC All Normalized by Dose

C92328

AUMCLSTS

C92329

AUMCLSTW

C85766

AUMCPEO

C85790

AUMCPEP

C85570 C92338

AUMCTAU AUMCTAUB

C92339

AUMCTAUD

C92340

AUMCTAUS

C92341

AUMCTAUW

C85841 C92342

AURCALL AURCALLB

C92343

AURCALLD

C92344

AURCALLS

AURC All Normalized by Surface Area AURC All Normalized by Weight

C92345

AURCALLW

C85767

AURCIFO

Observed Area Under the Urinary Excretion Rate Curve infinity

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 392 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym AURC Infinity Obs Norm by BMI AURC Infinity Obs Norm by Dose AURC Infinity Obs Norm by SA AURC Infinity Obs Norm by WT AURC Infinity Pred AURC Infinity Pred Norm by BMI AURC Infinity Pred Norm by Dose AURC Infinity Pred Norm by SA AURC Infinity Pred Norm by WT AURC from T1 to T2 AURC from T1 to T2 Norm by BMI AURC from T1 to T2 Norm by Dose AURC from T1 to T2 Norm by SA AURC from T1 to T2 Norm by WT AURC to Last Nonzero Rate AURC to Last Nonzero Rate Norm by BMI

NCI Code C92354

CDISC Submission Value AURCIFOB

CDISC Definition The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the body mass index. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the dose. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last observed excretion rate, divided by the weight. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the body mass index. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the dose. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) extrapolated to infinity, based on the last predicted excretion rate, divided by the weight. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the body mass index. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the dose. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the surface area. The area under the urinary excretion rate curve (AURC) over the interval from T1 to T2 divided by the weight. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the body mass index.

NCI Preferred Term AURC Infinity Observed Normalized by Body Mass Index

C92355

AURCIFOD

AURC Infinity Observed Normalized by Dose AURC Infinity Observed Normalized by Surface Area AURC Infinity Observed Normalized by Weight Predicted Area Under the Urinary Excretion Rate Curve Infinity AURC Infinity Predicted Normalized by Body Mass Index

C92356

AURCIFOS

C92357

AURCIFOW

C85791

AURCIFP

C92358

AURCIFPB

C92359

AURCIFPD

AURC Infinity Predicted Normalized by Dose AURC Infinity Predicted Normalized by Surface Area AURC Infinity Predicted Normalized by Weight Area Under the Urinary Excretion Rate Curve from T1 to T2 AURC from T1 to T2 Normalized by Body Mass Index AURC from T1 to T2 Normalized by Dose AURC from T1 to T2 Normalized by Surface Area AURC from T1 to T2 Normalized by Weight Area Under the Urinary Excretion Rate Curve From Dosing to Last Concentration AURC Dosing to Last Concentration Normalized by Body Mass Index

C92360

AURCIFPS

C92361

AURCIFPW

C85572 C92350

AURCINT AURCINTB

C92351

AURCINTD

C92352

AURCINTS

C92353

AURCINTW

C85571

AURCLST

C92346

AURCLSTB

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 393 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym AURC to Last Nonzero Rate Norm by Dose AURC to Last Nonzero Rate Norm by SA AURC to Last Nonzero Rate Norm by WT AURC % Extrapolation Obs AURC % Extrapolation Pred Initial Conc Initial Conc Norm by BMI Initial Conc Norm by Dose Initial Conc Norm by SA Initial Conc Norm by WT Average Conc; Average Concentration Average Conc Norm by BMI Average Conc Norm by Dose Average Conc Norm by SA Average Conc Norm by WT Total CL Obs by F; Total CL Obs by Fraction Dose (Bioavailability) Total CL Obs by Fract Dose Norm by BMI Total CL Obs by Fract Dose Norm by SA

NCI Code C92347

CDISC Submission Value AURCLSTD

CDISC Definition The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the dose. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the surface area. The area under the urinary excretion rate curve (AURC) from time zero to the last measurable rate, divided by the weight. The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity observed from Tlast to infinity. The percentage of the area under the urine excretion rate curve (AURC) extrapolated to infinity predicted from Tlast to infinity. Initial concentration. Given only for bolus IV models. Initial concentration divided by the body mass index. Given only for bolus IV models. Initial concentration divided by the dose. Given only for bolus IV models. Initial concentration divided by the surface area. Given only for bolus IV models. Initial concentration divided by the weight. Given only for bolus IV models. AUCTAU divided by TAU.

NCI Preferred Term AURC Dosing to Last Concentration Normalized by Dose AURC Dosing to Last Concentration Normalized by Surface Area AURC Dosing to Last Concentration Normalized by Weight Observed Area Under the Urinary Excretion Rate Curve Percent Extrapolation Predicted Area Under the Urinary Excretion Rate Curve Percent Extrapolation Initial Concentration Initial Concentration Normalized by Body Mass Index Initial Concentration Normalized by Dose Initial Concentration Normalized by Surface Area Initial Concentration Normalized by Weight Average Concentration

C92348

AURCLSTS

C92349

AURCLSTW

C85768

AURCPEO

C85792

AURCPEP

C85644 C92383 C92384 C92385 C92386 C85575

C0 C0B C0D C0S C0W CAVG

C92367 C92368 C92369 C92370 C85772

CAVGB CAVGD CAVGS CAVGW CLFO

AUCTAU divided by TAU and then divided by the body Average Concentration Normalized mass index. by Body Mass Index AUCTAU divided by TAU and then divided by the dose. Average Concentration Normalized by Dose AUCTAU divided by TAU and then divided by the surface area. AUCTAU divided by TAU and then divided by the weight. The observed total body clearance for extravascular administration based on the fraction of dose absorbed. Average Concentration Normalized by Surface Area Average Concentration Normalized by Weight Observed Total Body Clearance by Fraction of Dose Absorbed

C92399

CLFOB

The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index. The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area.

Total Clearance Observed by Fraction Dose Normalized by Body Mass Index Total Clearance Observed by Fraction Dose Normalized by Surface Area

C92401

CLFOS

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 394 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Total CL Obs by Fract Dose Norm by WT Total CL Pred by Fract Dose Total CL Pred by Fract Dose Norm by BMI Total CL Pred by Fract Dose Norm by SA Total CL Pred by Fract Dose Norm by WT Total CL Obs Total CL Obs Norm by BMI Total CL Obs Norm by SA Total CL Obs Norm by WT Total CL Pred Total CL Pred Norm by BMI Total CL Pred Norm by SA Total CL Pred Norm by WT Last Nonzero Conc Last Nonzero Conc Norm by BMI Last Nonzero Conc Norm by Dose Last Nonzero Conc Norm by SA Last Nonzero Conc Norm by WT Max Conc

NCI Code C92402

CDISC Submission Value CLFOW

CDISC Definition The observed total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the body mass index. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the surface area. The predicted total body clearance for extravascular administration based on the fraction of dose absorbed and divided by the weight. The observed total body clearance for intravascular administration. The observed total body clearance for intravascular administration divided by the body mass index. The observed total body clearance for intravascular administration divided by the surface area. The observed total body clearance for intravascular administration divided by the weight. The predicted total body clearance for intravascular administration. The predicted total body clearance for intravascular administration divided by the body mass index. The predicted total body clearance for intravascular administration divided by the surface area. The predicted total body clearance for intravascular administration divided by the weight. The concentration corresponding to Tlast. The concentration corresponding to Tlast divided by the body mass index. The concentration corresponding to Tlast divided by the dose. The concentration corresponding to Tlast divided by the surface area. The concentration corresponding to Tlast divided by the weight. The maximum concentration occurring at Tmax.

NCI Preferred Term Total Clearance Observed by Fraction Dose Normalized by Weight Predicted Total Body Clearance by Fraction of Dose Absorbed Total Clearance Predicted by Fraction Dose Normalized by Body Mass Index Total Clearance Predicted by Fraction Dose Normalized by Surface Area Total Clearance Predicted by Fraction Dose Normalized by Weight Observed Total Body Clearance Rate Total Clearance Observed Normalized by Body Mass Index Total Clearance Observed Normalized by Surface Area Total Clearance Observed Normalized by Weight Predicted Total Body Clearance Rate Total Clearance Predicted Normalized by Body Mass Index Total Clearance Predicted Normalized by Surface Area Total Clearance Predicted Normalized by Weight Last Concentration Last Concentration Normalized by Body Mass Index Last Concentration Normalized by Dose Last Concentration Normalized by Surface Area Last Concentration Normalized by Weight Cmax

C85796 C92417

CLFP CLFPB

C92419

CLFPS

C92420

CLFPW

C85773 C92403 C92405 C92406 C85797 C92421 C92423 C92424 C85655 C92387

CLO CLOB CLOS CLOW CLP CLPB CLPS CLPW CLST CLSTB

C92388

CLSTD

C92389

CLSTS

C92390

CLSTW

C70918

CMAX

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 395 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Max Conc Norm by BMI Max Conc Norm by Dose Max Conc Norm by SA Max Conc Norm by WT Min Conc Min Conc Norm by BMI Min Conc Norm by Dose Min Conc Norm by SA Min Conc Norm by WT Conc Conc by BMI Conc by Dose Conc by SA Conc by WT Correlation Between TimeX and Log ConcY Conc Trough Conc Trough by BMI Conc Trough by Dose Conc Trough by SA Conc Trough by WT Effective Half-Life Last Meas Excretion Rate

NCI Code C92371 C85698 C92372 C92373 C85579 C92374

CDISC Submission Value CMAXB CMAXD CMAXS CMAXW CMIN CMINB

CDISC Definition The maximum concentration occurring at Tmax, divided by the body mass index. The maximum concentration occurring at Tmax, divided by the dose. The maximum concentration occurring at Tmax, divided by the surface area. The maximum concentration occurring at Tmax, divided by the weight. The minimum concentration between dose time and dose time plus Tau (at Tmin). The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the body mass index. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the dose. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the surface area. The minimum concentration between dose time and dose time plus Tau (at Tmin) divided by the weight. The quantity of a specified substance in a unit volume or weight of another substance. The concentration divided by body mass index. The concentration divided by dose. The concentration divided by surface area. The concentration divided by weight. The correlation between time (X) and log concentration (Y) for the points used in the estimation of lambda z. Concentration at end of dosing interval. The trough concentration divided by body mass index. The trough concentration divided by dose. The trough concentration divided by surface area. The trough concentration divided by weight. The drug half-life that quantifies the accumulation ratio of a drug following multiple dosing. The last measurable (positive) excretion rate.

NCI Preferred Term Maximum Concentration Normalized by Body Mass Index Maximum Concentration Dose Normalized Maximum Concentration Normalized by Surface Area Maximum Concentration Normalized by Weight Cmin Minimum Concentration Normalized by Body Mass Index Minimum Concentration Normalized by Dose Minimum Concentration Normalized by Surface Area Minimum Concentration Normalized by Weight Concentration Concentration Divided by Body Mass Index Concentration Divided by Dose Concentration Divided by Surface Area Concentration Divided by Weight Time and Log Concentration Correlation Trough Concentration Trough Concentration Divided by Body Mass Index Trough Concentration Divided by Dose Trough Concentration Divided by Surface Area Trough Concentration Divided by Weight Effective Half-life Last Measurable Observed Excretion Rate

C92375 C92376

CMIND CMINS

C92377 C41185 C102367 C102368 C102369 C102370 C85821

CMINW CONC CONCB CONCD CONCS CONCW CORRXY

C102394 C102395 C102396 C102397 C102398 C95007 C85656

CTROUGH CTROUGHB CTROUGHD CTROUGHS CTROUGHW EFFHL ERLST

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 396 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Last Meas Excretion Rate Norm by BMI Last Meas Excretion Rate Norm by Dose Last Meas Excretion Rate Norm by SA Last Meas Excretion Rate Norm by WT Max Obs Excretion Rate Max Obs Excretion Rate Norm by BMI Max Obs Excretion Rate Norm by Dose Max Obs Excretion Rate Norm by SA Max Obs Excretion Rate Norm by WT Time of Max Excretion Rate Fluctuation% Lambda z Half-Life Lambda z Lambda z Lower Limit Number of Points for Lambda z Lambda z Upper Limit Midpoint of Collection Interval MRT Infinity Obs

NCI Code C92391

CDISC Submission Value ERLSTB

CDISC Definition The last measurable (positive) excretion rate divided by the body mass index. The last measurable (positive) excretion rate divided by the dose. The last measurable (positive) excretion rate divided by the surface area. The last measurable (positive) excretion rate divided by the weight. The maximum observed excretion rate. The maximum observed excretion rate divided by the body mass index. The maximum observed excretion rate divided by the dose. The maximum observed excretion rate divided by the surface area. The maximum observed excretion rate divided by the weight. The midpoint of collection interval associated with the maximum observed excretion rate. The difference between Cmin and Cmax standardized to Cavg, between dose time and Tau. The first order rate constant associated with the terminal (log-linear) portion of the curve. Terminal half-life. The lower limit on time for values to be included in the calculation of Lambda z. The number of time points used in computing Lambda z. The upper limit on time for values to be included in the calculation of Lambda z. The midpoint of collection interval, which is associated with last Measurable rate. The observed mean residence time (MRT) extrapolated to infinity.

NCI Preferred Term Last Measurable Excretion Rate Normalized by Body Mass Index Last Measurable Excretion Rate Normalized by Dose Last Measurable Excretion Rate Normalized by Surface Area Last Measurable Excretion Rate Normalized by Weight Maximum Observed Excretion Rate Maximum Observed Excretion Rate Normalized by Body Mass Index Maximum Observed Excretion Rate Normalized by Dose Maximum Observed Excretion Rate Normalized by Surface Area Maximum Observed Excretion Rate Normalized by Weight Time of Maximum Observed Excretion Rate Concentration Variability Between Dose Time and Tau Lambda Z Terminal Half Life Lambda Z Time Lower Limit Sum of Lambda Z Timepoints

C92392

ERLSTD

C92393

ERLSTS

C92394

ERLSTW

C85699 C92395

ERMAX ERMAXB

C92396

ERMAXD

C92397

ERMAXS

C92398

ERMAXW

C85823 C85581 C85652 C85818 C85653 C85816

ERTMAX FLUCP LAMZ LAMZHL LAMZLL LAMZNPT

C85654 C85580

LAMZUL MIDPTLST

Lambda Z Time Upper Limit Collection Interval Midpoint

C85769

MRTIFO

Observed Mean Residence Time Infinity

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 397 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym MRT Infinity Pred MRT to Last Nonzero Conc Nonrenal CL Peak Trough Ratio R Squared R Squared Adjusted Amt Rec from T1 to T2 Amt Rec from T1 to T2 Norm by BMI Amt Rec from T1 to T2 Norm by SA Amt Rec from T1 to T2 Norm by WT Amt Rec Over Dosing Interval Amt Rec Over Dosing Interval Norm by BMI Amt Rec Over Dosing Interval Norm by SA Amt Rec Over Dosing Interval Norm by WT Pct Rec from T1 to T2 Pct Rec from T1 to T2 Norm by BMI Pct Rec from T1 to T2 Norm by SA

NCI Code C85793 C85700 C102376 C102381 C85542 C85553

CDISC Submission Value MRTIFP MRTLST NRENALCL PTROUGHR R2 R2ADJ

CDISC Definition The predicted mean residence time (MRT) extrapolated to infinity. Mean residence time (MRT) from the time of dosing to the time of the last measurable concentration. The total clearance of a substance from the blood less the renal clearance. The ratio of Cmax to Ctrough during a dosing interval. The goodness of fit statistic for the terminal elimination phase. The goodness of fit statistic for the terminal elimination phase, adjusted for the number of time points used in the estimation of Lambda z. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by body mass index. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by surface area. The cumulative amount recovered from the specimen type specified in PPSPEC over the interval from T1 to T2 divided by weight. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU). The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by body mass index. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by surface area. The cumulative amount recovered from the specimen type specified in PPSPEC between doses (TAU) divided by weight. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by body mass index. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by surface area.

NCI Preferred Term Predicted Mean Residence Time Infinity Mean Residence Time Last Nonrenal Clearance Peak Trough Ratio R Squared Adjusted R Squared

C102359

RCAMINT

Amount Recovered from T1 to T2

C102360

RCAMINTB

Amount Recovered from T1 to T2 Normalized by Body Mass Index Amount Recovered from T1 to T2 Normalized by Surface Area Amount Recovered from T1 to T2 Normalized by Weight Amount Recovered Over Dosing Interval Amount Recovered Over Dosing Interval Normalized by Body Mass Index Amount Recovered Over Dosing Interval Normalized by Surface Area Amount Recovered Over Dosing Interval Normalized by Weight Percent Recovered from T1 to T2

C102361

RCAMINTS

C102362

RCAMINTW

C102363 C102364

RCAMTAU RCAMTAUB

C102365

RCAMTAUS

C102366

RCAMTAUW

C102382

RCPCINT

C102383

RCPCINTB

Percent Recovered from T1 to T2 Normalized by Body Mass Index

C102384

RCPCINTS

Percent Recovered from T1 to T2 Normalized by Surface Area

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 398 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Pct Rec from T1 to T2 Norm by WT Pct Rec Over Dosing Interval Pct Rec Over Dosing Interval Norm by BMI Pct Rec Over Dosing Interval Norm by SA Pct Rec Over Dosing Interval Norm by WT Renal CL Time Until First Nonzero Conc Time of Last Nonzero Conc Time of CMAX Time of CMIN Observation Vol Dist Initial Vol Dist Initial Norm by BMI Vol Dist Initial Norm by Dose Vol Dist Initial Norm by SA Vol Dist Initial Norm by WT Sum of Urine Vol Vol Dist Steady State Obs

NCI Code C102385

CDISC Submission Value RCPCINTW

CDISC Definition The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, over the interval between T1 and T2 divided by weight. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU). The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by the body mass index. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by surface area. The percentage of the administered dose that is recovered from the specimen type specified in PPSPEC, between doses (TAU) divided by weight. The clearance of a substance from the blood by the kidneys. The time prior to the first measurable (non-zero) concentration. The time of the last measurable (positive) concentration. The time of maximum observed concentration sampled during a dosing interval. The time of minimum concentration sampled during a dosing interval. The initial volume of distribution for a substance administered by bolus intravascular dosing. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the body mass index. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the dose. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the surface area. The initial volume of distribution for a substance administered by bolus intravascular dosing divided by the weight. The sum of urine volumes that are used for PK parameters. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing.

NCI Preferred Term Percent Recovered from T1 to T2 Normalized by Weight

C102386

RCPCTAU

Percent Recovered Over Dosing Interval Percent Recovered Over Dosing Interval Normalized by Body Mass Index Percent Recovered Over Dosing Interval Normalized by Surface Area

C102387

RCPCTAUB

C102388

RCPCTAUS

C102389

RCPCTAUW

Percent Recovered Over Dosing Interval Normalized by Weight Renal Clearance Time until First Nonzero Concentration Time of Last Nonzero Concentration Tmax Tmin Initial Volume of Distribution Initial Volume of Distribution Normalized by Body Mass Index Initial Volume of Distribution Normalized by Dose Initial Volume of Distribution Normalized by Surface Area Initial Volume of Distribution Normalized by Weight Sum Urine Volume Observed Steady State Volume of Distribution

C75913 C85824 C85822 C70919 C85825 C102371 C102372

RENALCL TLAG TLST TMAX TMIN V0 V0B

C102373

V0D

C102374

V0S

C102375

V0W

C85817 C85770

VOLPK VSSO

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 399 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Vol Dist Steady State Obs Norm by BMI Vol Dist Steady State Obs Norm by Dose Vol Dist Steady State Obs Norm by SA Vol Dist Steady State Obs Norm by WT Vol Dist Steady State Pred Vol Dist Steady State Pred Norm by BMI Vol Dist Steady State Pred Norm by Dose Vol Dist Steady State Pred Norm by SA Vol Dist Steady State Pred Norm by WT Vol Dist of Fract Dose Obs

NCI Code C102377

CDISC Submission Value VSSOB

CDISC Definition The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the body mass index. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the dose. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the surface area. The volume of distribution at steady state based on the observed CLST for a substance administered by intravascular dosing divided by the weight. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the body mass index. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the dose. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the surface area. The volume of distribution at steady state based on the predicted CLST for a substance administered by intravascular dosing divided by the weight. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area. The observed volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed.

NCI Preferred Term Observed Steady State Volume of Distribution Normalized by Body Mass Index Observed Steady State Volume of Distribution Normalized by Dose Observed Steady State Volume of Distribution Normalized by Surface Area Observed Steady State Volume of Distribution Normalized by Weight Predicted Steady State Volume of Distribution Predicted Steady State Volume of Distribution Normalized by Body Mass Index Predicted Steady State Volume of Distribution Normalized by Dose Predicted Steady State Volume of Distribution Normalized by Surface Area Predicted Steady State Volume of Distribution Normalized by Weight Observed Volume of Distribution of Absorbed Fraction

C102378

VSSOD

C102379

VSSOS

C102380

VSSOW

C85794

VSSP

C102390

VSSPB

C102391

VSSPD

C102392

VSSPS

C102393

VSSPW

C85775

VZFO

C92410

VZFOB

Vol Dist of Fract Dose Obs Norm by BMI

Volume of Distribution of Fraction Dose Observed Normalized by Body Mass Index

C92411

VZFOS

Vol Dist of Fract Dose Obs Norm by SA Vol Dist of Fract Dose Obs Norm by WT Vol Dist of Fract Dose Pred

Volume of Distribution of Fraction Dose Observed Normalized by Surface Area Volume of Distribution of Fraction Dose Observed Normalized by Weight Predicted Volume of Distribution of Absorbed Fraction

C92412

VZFOW

C85799

VZFP

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 400 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85839 - PKPARMCD - PK Parameters Code Codelist extensible: Yes
CDISC Synonym Vol Dist of Fract Dose Pred Norm by BMI

NCI Code C92428

CDISC Submission Value VZFPB

CDISC Definition The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the body mass index. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the surface area. The predicted volume of distribution of the absorbed fraction associated with the terminal slope following extravascular administration, where F equals the fraction of dose absorbed, divided by the weight. The observed volume of distribution associated with the terminal slope following intravascular administration. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the surface area. The observed volume of distribution associated with the terminal slope following intravascular administration divided by the weight. The predicted volume of distribution associated with the terminal slope following intravascular administration. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the body mass index. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the surface area. The predicted volume of distribution associated with the terminal slope following intravascular administration divided by the weight.

NCI Preferred Term Volume of Distribution of Fraction Dose Predicted Normalized by Body Mass Index

C92429

VZFPS

Vol Dist of Fract Dose Pred Norm by SA Vol Dist of Fract Dose Pred Norm by WT Vz Obs

Volume of Distribution of Fraction Dose Predicted Normalized by Surface Area Volume of Distribution of Fraction Dose Predicted Normalized by Weight Observed Volume of Distribution

C92430

VZFPW

C85774

VZO

C92407

VZOB

Vz Obs Norm by BMI Vz Obs Norm by SA Vz Obs Norm by WT Vz Pred

Volume of Distribution Observed Normalized by Body Mass Index Volume of Distribution Observed Normalized by Surface Area Volume of Distribution Observed Normalized by Weight Predicted Volume of Distribution

C92408

VZOS

C92409

VZOW

C85798

VZP

C92425

VZPB

Vz Pred Norm by BMI Vz Pred Norm by SA Vz Pred Norm by WT

Volume of Distribution Predicted Normalized by Body Mass Index Volume of Distribution Predicted Normalized by Surface Area Volume of Distribution Predicted Normalized by Weight

C92426

VZPS

C92427

VZPW

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 401 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Per Hour IU/d IU/h IU/min IU/sec; IU/s Liter

NCI Code C66966 C85645 C85646 C85647 C85648 C48505

CDISC Submission Value /h IU/day IU/h IU/min IU/s L

CDISC Definition A rate of occurrences of something within a period of time equal to sixty minutes. International units per day. International units per hour. International units per minute. International units per second. A unit of volume equal to a cubic decimeter, or one thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches.(NCI) Liters per day.

NCI Preferred Term Per Hour International Unit per Day International Unit per Hour International Unit per Minute International Unit per Second Liter

C69110 C85657

L/day L/g/day mL/mg/day; uL/ug/day; L/day/g; L/g/d L/h/g; mL/mg/h; uL/ug/h; mL/h/mg; uL/h/ug; L/g/h mL/mg/min; uL/ug/min; L/min/g; L/g/min L/g/sec; mL/mg/s; uL/ug/s; L/s/g; mL/mg/sec; uL/ug/sec; L/sec/g; L/g/s L/h Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d

Liter per Day Liter per Gram per Day

Liters per gram per day.

C85658

L/g/h

Liters per gram per hour.

Liter per Gram per Hour

C85659

L/g/min

Liters per gram per minute.

Liter per Gram per Minute

C85660

L/g/s

Liters per gram per second.

Liter per Gram per Second

C69160 C73755

L/h L/kg/day

Liters per hour. Liters per kilogram per day.

Liter per Hour Milliliter per Gram per Day

C73756 C73757 C85664

L/kg/h L/kg/min L/kg/s L/kg/sec; mL/g/s; uL/mg/s; L/s/kg; L/sec/kg; mL/s/g; uL/s/mg; L/kg/s mL/ug/day; L/day/mg; mL/day/ug; L/mg/d

Milliliters per gram per hour. Milliliters per gram per minute. Liters per kilogram per second.

Milliliter per Gram per Hour Milliliter per Gram per Minute Liter per Kilogram per Second

C85672

L/mg/day

Liters per milligram per day.

Liter per Milligram per Day

C85673

L/mg/h

mL/ug/h; L/h/mg; Liters per milligram per hour. mL/h/ug; L/mg/h

Liter per Milligram per Hour

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 402 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym mL/ug/min; L/min/mg; mL/min/ug; L/mg/min mL/ug/s; L/s/mg; mL/s/ug; mL/ug/sec; L/sec/mg; mL/sec/ug; L/mg/s Liters per Minute mL/umol/day; L/day/mmol; mL/day/umol; L/mmol/d mL/umol/h; L/h/mmol; mL/h/umol; L/mmol/h mL/umol/min; L/min/mmol; mL/min/umol; L/mmol/min L/mmol/sec; L/s/mmol; L/sec/mmol; mL/umol/s; mL/umol/sec; mL/s/umol; mL/sec/umoL; L/mmol/s mL/mmol; uL/umol; L/mol L/day/mol; mL/mmol/day; uL/umol/day; mL/day/mmol; uL/day/umol; L/mol/d L/h/mol; mL/mmol/h; uL/umol/h; mL/h/mmol; uL/h/umol; L/mol/h L/min/mol; mL/mmol/min; uL/umol/min; mL/min/mmol; uL/min/umol; L/mol/min

NCI Code C85674

CDISC Submission Value L/mg/min

CDISC Definition Liters per milligram per minute.

NCI Preferred Term Liter per Milligram per Minute

C85675

L/mg/s

Liters per milligram per second.

Liter per Milligram per Second

C67388

L/min

A unit of volumetric flow rate defined as the rate at which one liter of matter travels during the period of time equal to one minute.(NCI) Liters per millimole per day.

Liter per Minute

C85676

L/mmol/day

Liter per Millimole per Day

C85677

L/mmol/h

Liters per millimole per hour.

Liter per Millimole per Hour

C85678

L/mmol/min

Liters per millimole per minute.

Liter per Millimole per Minute

C85679

L/mmol/s

Liters per millimole per second.

Liter per Millimole per Second

C85680 C85681

L/mol L/mol/day

Liters per mole. Liters per mole per day.

Liter per Mole Liter per Mole per Day

C85682

L/mol/h

Liters per mole per hour.

Liter per Mole per Hour

C85683

L/mol/min

Liters per mole per minute.

Liter per Mole per Minute

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 403 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym L/mol/sec; L/s/mol; L/sec/mol; mL/mmol/s; mL/mmol/sec; mL/s/mmol; mL/sec/mmol; L/mol/s L/day/ng; mL/pg/day; mL/day/pg; L/ng/d L/h/ng; mL/pg/h; mL/h/pg; L/ng/h L/min/ng; mL/pg/min; mL/min/pg; L/ng/min L/s/ng; L/ng/sec; L/sec/ng; mL/pg/s; mL/s/pg; mL/pg/sec; mL/sec/pg; L/ng/s mL/pmol/day; L/day/nmol; mL/day/pmol; L/nmol/d mL/pmol/h; L/h/nmol; mL/h/pmol; L/nmol/h mL/pmol/min; L/min/nmol; mL/min/pmol; L/nmol/min L/nmol/sec; mL/pmol/s; mL/s/pmol; L/s/nmol; L/sec/nmol; L/nmol/s L/day/pg; L/pg/d L/h/pg; L/pg/h L/min/pg; L/pg/min L/pg/sec; L/s/pg; L/sec/pg; L/pg/s L/sec

NCI Code C85684

CDISC Submission Value L/mol/s

CDISC Definition Liters per mole per second.

NCI Preferred Term Liter per Mole per Second

C85685

L/ng/day

Liters per nanogram per day.

Liter per Nanogram per Day

C85686 C85687

L/ng/h L/ng/min

Liters per nanogram per hour. Liters per nanogram per minute.

Liter per Nanogram per Hour Liter per Nanogram per Minute

C85688

L/ng/s

Liters per nanogram per second.

Liter per Nanogram per Second

C85689

L/nmol/day

Liters per nanomole per day.

Liter per Nanomole per Day

C85690

L/nmol/h

Liters per nanomole per hour.

Liter per Nanomole per Hour

C85691

L/nmol/min

Liters per nanomole per minute.

Liter per Nanomole per Minute

C85692

L/nmol/s

Liters per nanomole per second.

Liter per Nanomole per Second

C85693 C85694 C85695 C85696 C67390

L/pg/day L/pg/h L/pg/min L/pg/s L/s

Liters per picogram per day. Liters per picogram per hour. Liters per picogram per minute. Liters per picogram per second. Liters per second.

Liter per Picogram per Day Liter per Picogram per Hour Liter per Picogram per Minute Liter per Picogram per Second Liter per Second

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 404 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym L/mcg/day; L/day/ug; L/day/mcg; mL/day/ng; mL/ng/day L/mcg/h; L/h/ug; L/h/mcg; mL/h/ng; mL/ng/h; L/ug/h L/mcg/min; L/min/ug; L/min/mcg; mL/min/ng; mL/ng/min L/ug/sec; L/s/ug; L/ug/s; L/sec/ug; L/mcg/sec; L/s/mcg; L/mcg/s; L/sec/mcg; mL/ng/s; mL/s/ng L/mcmol/day; L/day/umol; L/day/mcmol; L/umol/d L/mcmol/h; L/h/umol; L/h/mcmol; L/umol/h L/mcmol/min; L/min/umol; L/min/mcmol; L/umol/min L/mcmol/s; L/umol/sec; L/s/umol; L/sec/umol; L/mcmol/sec; L/sec/mcmol; mL/nmol/s; mL/s/nmol; L/umol/s pg*day/L; day*pg/L; fg*day/mL; d*fg/mL g*day/mL; day*kg/L; kg*day/L; d*g/mL

NCI Code C85665

CDISC Submission Value L/ug/day

CDISC Definition Liters per microgram per day.

NCI Preferred Term Liter per Microgram per Day

C85662

L/ug/h

Liters per microgram per hour.

Liter per Microgram per Hour

C85666

L/ug/min

Liters per microgram per minute.

Liter per Microgram per Minute

C85667

L/ug/s

Liters per microgram per second.

Liter per Microgram per Second

C85668

L/umol/day

Liters per micromole per day.

Liter per Micromole per Day

C85669

L/umol/h

Liters per micromole per hour.

Liter per Micromole per Hour

C85670

L/umol/min

Liters per micromole per minute.

Liter per Micromole per Minute

C85671

L/umol/s

Liters per micromole per second.

Liter per Micromole per Second

C85583

day*fg/mL

Days times femtograms per milliliter.

Day Times Femtogram per Milliliter

C85584

day*g/mL

Days times grams per milliliter.

Day Times Gram per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 405 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym kg*day/mL; g*day/uL; day*g/uL; d*kg/mL mg*day/mL; day*g/L; g*day/L; day*ug/uL; ug*day/uL; d*mg/mL mmol*day/mL; day*mol/L; mol*day/L; day*umol/uL; umol*day/uL; d*mmol/mL mol*day/mL; d*mol/mL ng*day/mL; day*ug/L; ug*day/L; d*ng/mL nmol*day/mL; day*umol/L; umol*day/L; d*nmol/mL pg*day/mL; day*ng/L; ng*day/L; d*pg/mL nmol*day/L; day*nmol/L; pmol*day/mL; d*pmol/mL ug*day/mL; day*mg/L; mg*day/L; day*mcg/mL; mcg*day/mL umol*day/mL; day*mmol/L; mmol*day/L; day*mcmol/mL; mcmol*day/mL; d*umol/mL pg/L; fg/mL Gram gram/day; g/d gram/h; g/h

NCI Code C85585

CDISC Submission Value day*kg/mL

CDISC Definition Days times kilograms per milliliter.

NCI Preferred Term Day Times Kilogram per Milliliter

C85588

day*mg/mL

Days times milligrams per milliliter.

Day Times Milligram per Milliliter

C85589

day*mmol/mL

Days times millimoles per milliliter.

Day Times Millimole per Milliliter

C85590 C85591

day*mol/mL day*ng/mL

Days times moles per milliliter. Days times nanograms per milliliter.

Day Times Mole per Milliliter Day Times Nanogram per Milliliter

C85592

day*nmol/mL

Days times nanomoles per milliliter.

Day Times Nanomole per Milliliter

C85593

day*pg/mL

Days times picograms per milliliter.

Day Times Picogram per Milliliter

C85594

day*pmol/mL

Days times picomoles per milliliter.

Day Times Picomole per Milliliter

C85586

day*ug/mL

Days times micrograms per milliliter.

Day Times Microgram per Milliliter

C85587

day*umol/mL

Days times micromoles per milliliter.

Day Times Micromole per Milliliter

C85597 C48155 C85600 C85601

fg/mL g g/day g/h

Femtograms per milliliter. A metric unit of mass equal to one one thousandth of a kilogram. (NCI) Grams per day. Grams per hour.

Femtogram per Milliliter Gram Gram per Day Gram per Hour

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 406 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL gram/min; g/min gram/sec; g/sec; gram/s; g/s pg*h/L; h*pg/L; fg*h/mL; h*fg/mL pmol*h/L; h*pmol/L; fmol*h/mL; h*fmol/mL g*h/mL; h*kg/L; kg*h/L; h*g/mL kg*h/mL; g*h/uL; h*g/uL; h*kg/mL mg*h/L/mg; h*mg/mg/L; mg*h/mg/L; h*mg/L/mg mg*h/mL; h*g/L; g*h/L; ug*h/uL; h*ug/uL; h*mg/mL mmol*h/mL; h*mol/L; mol*h/L; umol*h/uL; h*umol/uL; h*mmol/mL mol*h/mL; h*mol/mL ng*h/mL; h*ug/L; ug*h/L; h*ng/mL ng*h/mL*kg; h*ng/kg*mL; ng*h/kg*mL; h*ng/mL*kg ng*h/mL/g; h*ng/g/mL; ng*h/g/mL; h*ng/mL/g

NCI Code C64566

CDISC Submission Value g/mL

CDISC Definition A unit of mass concentration defined as the concentration of one kilogram of a substance in unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one kilogram occupies the volume one liter.(NCI) Grams per minute. Grams per second. Hours times femtograms per milliliter.

NCI Preferred Term Kilogram per Liter

C85602 C85603 C85611

g/min g/s h*fg/mL

Gram per Minute Gram per Second Hour Times Femtogram per Milliliter Hour Times Femtomole per Milliliter

C85612

h*fmol/mL

Hours times femtomoles per milliliter.

C85613 C85614

h*g/mL h*kg/mL

Hours times grams per milliliter. Hours times kilograms per milliliter.

Hour Times Gram per Milliliter Hour Times Kilogram per Milliliter

C85620

h*mg/L/mg

Hours times milligrams per liter per milligram.

Hour Times Milligram per Liter per Milligram

C85621

h*mg/mL

Hours times milligrams per milliliter.

Hour Times Milligram per Milliliter

C85622

h*mmol/mL

Hours times millimoles per milliliter.

Hour Times Millimole per Milliliter

C85623 C85624

h*mol/mL h*ng/mL

Hours times moles per milliliter. Hours times nanograms per milliliter.

Hour Times Mole per Milliliter Hour Times Nanogram per Milliliter

C85630

h*ng/mL*kg

Hours times nanograms per milliliter times kilogram.

Hour Times Nanogram per Milliliter Times Kilogram

C85625

h*ng/mL/g

Hours times nanograms per milliliter per gram.

Hour Times Nanogram per Milliliter per Gram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 407 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym ng*h/mL/kg; ng*h/kg/mL; h*ng/kg/mL; h*ng/mL/kg ng*h/mL/mg; h*ng/mg/mL; ng*h/mg/mL; h*ng/mL/mg ng*h/mL/mg/kg; h*ng/mL/mg h*ng/mL/mg/ m^2; h*ng/mL/mg/m* m; ng*h/mL/mg/m2 h*nmol/L/ mcmol; nmol*h/L/umol; h*nmol/umol/L; nmol*h/umol/L umol*h/L; h*umol/L; nmol*h/mL; h*nmol/mL nmol*h/mL/mg; h*nmol/mg/mL; nmol*h/mg/mL; h*nmol/mL/mg pg*h/mL; h*ng/L; ng*h/L; h*pg/mL pg*h/mL/kg; h*pg/kg/mL; pg*h/kg/mL; h*pg/mL/kg pg*h/mL/mg; h*pg/mg/mL; pg*h/mg/mL; h*pg/mL/mg h*pg/mL/mcg; pg*h/mL/ug; h*pg/ug/mL; pg*h/ug/mL pmol*h/L/ug; h*pmol/L/mcg; h*pmol/ug/L; pmol*h/ug/L pmol*h/mL; h*nmol/L; nmol*h/L; h*pmol/mL

NCI Code C85626

CDISC Submission Value h*ng/mL/kg

CDISC Definition Hours times nanograms per milliliter per kilogram.

NCI Preferred Term Hour Times Nanogram per Milliliter per Kilogram

C85627

h*ng/mL/mg

Hours times nanograms per milliliter per milligram.

Hour Times Nanogram per Milliliter per Milligram

C85628 C85629

h*ng/mL/mg/kg h*ng/mL/mg/m2

Hours times nanograms per milliliter per milligram per kilogram. Hours times nanograms per milliliter per milligram per meter squared.

Hour Times Nanogram per Milliliter per Milligram per Kilogram Hour Times Nanogram per Milliliter per Milligram per Meter Squared

C85631

h*nmol/L/umol

Hours times nanomoles per liter per micromole.

Hour Times Nanomole per Liter per Micromole

C85632

h*nmol/mL

Hours times nanomoles per milliliter.

Hour Times Nanomole per Milliliter

C85634

h*nmol/mL/mg

Hours times nanomoles per milliliter per milligram.

Hour Times Nanomole per Milliliter per Milligram

C85635

h*pg/mL

Hours times picograms per milliliter.

Hour Times Picogram per Milliliter

C85636

h*pg/mL/kg

Hours times picograms per milliliter per kilogram.

Hour Times Picogram per Milliliter per Kilogram

C85638

h*pg/mL/mg

Hours times picograms per milliliter per milligram.

Hour Times Picogram per Milliliter per Milligram

C85637

h*pg/mL/ug

Hours times picograms per milliliter per microgram.

Hour Times Picogram per Milliliter per Microgram

C85639

h*pmol/L/ug

Hours times picomoles per liter per microgram.

Hour Times Picomole per Liter per Microgram

C85640

h*pmol/mL

Hours times picomoles per milliliter.

Hour Times Picomole per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 408 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym pmol*h/mL/mg; h*pmol/mg/mL; pmol*h/mg/mL; h*pmol/mL/mg mg*h/L; h*mg/L; h*ng/uL; ng*h/uL; h*ug/mL; h*mcg/mL; mcg*h/mL ug*h/mL/mg; h*mcg/mL/mg; h*ug/mg/mL; ug*h/mg/mL mmol*h/L; h*mmol/L; umol*h/mL; h*mcmol/mL; mcmol*h/mL; h*umol/mL mg*h2/mL; h^2*mg/mL; h*h*mg/mL; h2*g/L; h2*ug/uL mmol*h2/mL; h^2*mmol/mL; h*h*mmol/mL; h2*mol/L; h2*umol/uL ng*h2/mL; h^2*ng/mL; h*h*ng/mL; h2*ug/L pg*h2/mL; h^2*pg/mL; h*h*pg/mL; h2*ng/L pmol*h2/mL; h^2*pmol/mL; h*h*pmol/mL; h2*nmol/L ug*h2/mL; h^2*ug/mL; h*h*ug/mL; h2*mcg/mL; h2*mg/L umol*h2/mL; h^2*umol/mL; h*h*umol/mL; h2*mcmol/mL; h2*mmol/L

NCI Code C85641

CDISC Submission Value h*pmol/mL/mg

CDISC Definition Hours times picomoles per milliliter per milligram.

NCI Preferred Term Hour Times Picomole per Milliliter per Milligram

C85615

h*ug/mL

Hours times micrograms per milliliter.

Hour Times Microgram per Milliliter

C85617

h*ug/mL/mg

Hours times micrograms per milliliter per milligram.

Hour Times Microgram per Milliliter per Milligram

C85618

h*umol/mL

Hours times micromoles per milliliter.

Hour Times Micromole per Milliliter

C85606

h2*mg/mL

Hours squared times milligrams per milliliter.

Hour Squared Times Milligram per Milliliter

C85607

h2*mmol/mL

Hours squared times millimoles per milliliter.

Hour Squared Times Millimole per Milliliter

C85608

h2*ng/mL

Hours squared times nanograms per milliliter.

Hour Squared Times Nanogram per Milliliter

C85609

h2*pg/mL

Hours squared times picogram per milliliter.

Hour Squared Times Picogram per Milliliter

C85610

h2*pmol/mL

Hours squared times picomoles per milliliter.

Hour Squared Times Picomole per Milliliter

C85604

h2*ug/mL

Hours squared times micrograms per milliliter.

Hour Squared Times Microgram per Milliliter

C85605

h2*umol/mL

Hours squared times micromoles per milliliter.

Hour Squared Times Micromole per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 409 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym International Unit per Liter; IU/L; mIU/mL Milliliter; cm3

NCI Code C67376

CDISC Submission Value mIU/mL

CDISC Definition Unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one international unit per one liter of system volume.(NCI) The unit of volume equal to one thousandth of a liter, one cubic centimeter, 10E-6 cubic meter, or approximately to 0.061 023 7 cubic inch.(NCI) Milliliters per day.

NCI Preferred Term International Unit per Liter

C28254

mL

Milliliter

C73753 C66962

mL/day mL/h Milliliters per Hour Milliliter per Kilogram per Day Milliliter per Kilogram per Hour Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min mL/sec/kg; mL/s/kg; mL/kg/sec; mL/kg/s Milliliters per Minute uL/mmol/day; mL/day/mol; uL/day/mmol; mL/mol/d uL/mmol/h; mL/h/mol; uL/h/mmol; mL/mol/h uL/mmol/min; mL/min/mol; uL/min/mmol; mL/mol/min mL/sec/mol; mL/s/mol; mL/mol/sec; mL/mol/s mL/sec

Milliliter per Day Milliliter per Hour

A unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one hour.(NCI) Milliliters per kilogram per day.

C73758

mL/kg/day

Milliliter per Kilogram per Day

C73759

mL/kg/h

Milliliters per kilogram per hour.

Milliliter per Kilogram per Hour

C73760

mL/kg/min

Milliliters per kilogram per minute.

Milliliter per Kilogram per Minute

C85715

mL/kg/s

Milliliters per kilogram per second.

Milliliter per Kilogram per Second

C64777

mL/min

A metric unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one minute.(NCI) Milliliters per mole per day.

Milliliter per Minute

C85716

mL/mol/day

Milliliter per Mole per Day

C85717

mL/mol/h

Milliliters per mole per hour.

Milliliter per Mole per Hour

C85718

mL/mol/min

Milliliters per mole per minute.

Milliliter per Mole per Minute

C85719

mL/mol/s

Milliliters per mole per second.

Milliliter per Mole per Second

C69073

mL/s

Milliliters per second.

Milliliter per Second

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 410 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Milligram

NCI Code C28253

CDISC Submission Value mg

CDISC Definition The unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015432 grain or 35.274 x 10E-6 ounce.(NCI) Milligrams per liter per milligram. A unit of measure referring to the ratio between mass expressed in milligrams per day.(NCI) A unit of mass flow rate equivalent to the rate at which one thousandth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) A unit of mass concentration defined as the concentration of one kilogram of a substance per unit volume of the mixture equal to one cubic meter, or the concentration of one milligram of a substance per unit volume of the mixture equal to one milliliter, or one gram of a substance per one liter of the mixture. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one milliliter.(NCI) Milligrams per milliliter per hour.

NCI Preferred Term Milligram

C85710 C67399 C66969

mg/L/mg mg/day mg/h

mg/mg/L; mg/L/mg Milligram per Day Milligram per Hour

Milligram per Liter per Milligram Milligram per 24 Hours Milligram per Hour

C42576

mg/mL

g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL; mg/mL g/L/h; ug/uL/h; mg/h/mL; g/h/L; ug/h/uL

Kilogram per Cubic Meter

C85711

mg/mL/h

Milligram per Milliliter per Hour

C73742 C85712 C85724

mg/min mg/s min*fg/mL mg/sec; mg/s pg*min/L; min*pg/L; fg*min/mL; min*fg/mL g*min/mL; min*kg/L; kg*min/L; min*g/mL kg*min/mL; g*min/uL; min*g/uL; min*kg/mL mg*min/mL; min*g/L; g*min/L; ug*min/uL; min*ug/uL; min*mg/mL mmol*min/mL; min*mol/L; mol*min/L; min*umol/uL; umol*min/uL; min*mmol/mL

Milligrams per minute. Milligrams per second. Minutes times femtograms per milliliter.

Milligram per Minute Milligram per Second Minute Times Femtogram per Milliliter

C85725

min*g/mL

Minutes times grams per milliliter.

Minute Times Gram per Milliliter

C85726

min*kg/mL

Minutes times kilograms per milliliter.

Minute Times Kilogram per Milliliter

C85729

min*mg/mL

Minutes times milligrams per milliliter.

Minute Times Milligram per Milliliter

C85730

min*mmol/mL

Minutes times millimoles per milliliter.

Minute Times Millimole per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 411 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym mol*min/mL; min*mol/mL ng*min/mL; min*ug/L; ug*min/L; min*ng/mL nmol*min/mL; min*umol/L; umol*min/L; min*nmol/mL pg*min/mL; min*ng/L; ng*min/L; min*pg/mL nmol*min/L; min*nmol/L; pmol*min/mL; min*pmol/mL ug*min/mL; min*mg/L; mg*min/L; min*mcg/mL; mcg*min/mL umol*min/mL; min*mcmol/mL; min*mmol/L; mmol*min/L; min*umol/mL

NCI Code C85731 C85732

CDISC Submission Value min*mol/mL min*ng/mL

CDISC Definition Minutes times moles per milliliter. Minutes times nanograms per milliliter.

NCI Preferred Term Minute Times Mole per Milliliter Minute Times Nanogram per Milliliter

C85733

min*nmol/mL

Minutes times nanomoles per milliliter.

Minute Times Nanomole per Milliliter

C85734

min*pg/mL

Minutes times picograms per milliliter.

Minute Times Picogram per Milliliter

C85735

min*pmol/mL

Minutes times picomoles per milliliter.

Minute Times Picomole per Milliliter

C85727

min*ug/mL

Minutes times micrograms per milliliter.

Minute Times Microgram per Milliliter

C85728

min*umol/mL

Minutes times micromoles per milliliter.

Minute Times Micromole per Milliliter

C85720 C48555 C85721

mmol/h mmol/mL mmol/mL/h Mole per Liter; mol/L; mmol/mL mol/L/h; umol/uL/h; mmol/h/mL; mol/h/L; umol/h/uL; mmol/mL/h

Millimoles per hour. A unit of concentration (molarity unit) equal to one mole of solute in one liter of solution.(NCI) Millimoles per milliliter per hour.

Millimole per Hour Mole per Liter Millimole per Milliliter per Hour

C85722 C85723 C85737 C85738 C85739 C85740 C69188 C85760

mmol/min mmol/s mol/day mol/h mol/min mol/s nL nU/mL mol/sec; mol/s Nanoliter uU/L; mcU/L; nU/mL mmol/sec; mmol/s mol/d

Millimoles per minute. Millimoles per second. Moles per day. Moles per hour. Moles per minute. Moles per second. A unit of volume equal to one billionth of a liter (10E-9 liter).(NCI) Nanounits per milliliter.

Millimole per Minute Millimole per Second Mole per Day Mole per Hour Mole per Minute Mole per Second Nanoliter Nanounit per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 412 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Nanogram ng/d

NCI Code C48516 C85741 C85742 C85743

CDISC Submission Value ng ng/day ng/h ng/kg/min

CDISC Definition A unit of mass equal to one billionth (10E-9) of a gram, or one millionth (10E-6) of a milligram.(NCI) Nanograms per day. Nanograms per hour.

NCI Preferred Term Nanogram Nanogram per Day Nanogram per Hour Nanogram per Kilogram per Minute

ng/min/kg; pg/g/min; pg/min/g; ng/kg/min mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L ng/kg*mL; ng/mL*kg ug/L/h; ng/h/mL; ng/mL/h ng/kg/mL; ng/mL/kg ng/mg/mL; ng/mL/mg ug/g of Creatinine; ng/mg of Creatinine

Nanograms per kilogram per minute.

C67306

ng/mL

A unit of mass concentration defined as the concentration of one microgram of a substance per unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one microgram occupies the volume one liter.(NCI) Nanograms per milliliter times kilogram. Nanograms per milliliter per hour. Nanograms per milliliter per kilogram. Nanograms per milliliter per milligram. Nanograms per milligram of creatinine.

Microgram per Liter

C85748 C67430 C85746 C85747 C85744

ng/mL*kg ng/mL/h ng/mL/kg ng/mL/mg ng/mg of Creatinine

Nanogram per Milliliter Times Kilogram Nanogram per Milliliter per Hour Nanogram per Milliliter per Kilogram Nanogram per Milliliter per Milligram Nanogram per Milligram of Creatinine

C85749 C85750 C85755

ng/min ng/s nmol/L/umol ng/sec; ng/s nmol/L/mcmol; nmol/umol/L; nmol/mcmol/L; nmol/L/umol nmol/d umol/kg; pmol/mg; nmol/g

Nanograms per minute. Nanograms per second. Nanomoles per liter per micromole.

Nanogram per Minute Nanogram per Second Nanomole per Liter per Micromole

C85751 C85752 C85753 C85754 C85756

nmol/day nmol/g nmol/h nmol/kg nmol/mL

Nanomoles per day. Nanomoles per gram. Nanomoles per hour.

Nanomole per Day Nanomole per Gram Nanomole per Hour Nanomole per Kilogram Nanomole per Milliliter

pmol/g; nmol/kg umol/L; mcmol/L; nmol/mL umol/L/h; nmol/h/mL; nmol/mL/h

Nanomoles per kilogram. Nanomoles per milliliter.

C85757

nmol/mL/h

Nanomoles per milliliter per hour.

Nanomole per Milliliter per Hour

C85758

nmol/min

Nanomoles per minute.

Nanomole per Minute

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 413 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym nmol/sec; nmol/s

NCI Code C85759 C67331 C85778 C85779 C67327

CDISC Submission Value nmol/s pg/dL pg/day pg/h pg/mL

CDISC Definition Nanomoles per second. Picograms per deciliter.

NCI Preferred Term Nanomole per Second Picogram per Deciliter Picogram per Day Picogram per Hour Nanogram per Liter

pg/d

Picograms per day. Picograms per hour.

ug/m3; Microgram per Cubic Meter; ng/L; pg/mL

A unit of mass concentration defined as the concentration of one nanogram of a substance per one liter of the mixture, or one picogram of a substance in unit volume of the mixture equal to one milliliter, or one microgram of a substance per one cubic meter of the mixture. The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which mass equal to one nanogram occupies the volume one liter.(NCI) Picograms per milliliter per microgram.

C85781

pg/mL/ug

pg/mL/mcg; pg/ug/mL; pg/mcg/mL mcg/kg; Microgram per Kilogram; ng/g; ug/kg ng/g of Creatinine; pg/mg of Creatinine

Picogram per Milliliter per Microgram Microgram per Kilogram

C67396

pg/mg

A unit of a mass fraction expressed as a number of micrograms of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) Picograms per milligram creatinine.

C85780

pg/mg Creatinine

Picogram per Milligram of Creatinine

C85782 C85783 C85784

pg/min pg/s pmol/L/ug pg/sec; pg/s pmol/L/mcg; pmol/ug/L; pmol/mcg/L pg*s/L; sec*fg/mL; s*pg/L; fg*s/mL; fg*sec/mL; s*fg/mL g*s/mL; sec*g/mL; g*sec/mL; s*kg/L; kg*s/L; sec*kg/L; kg*sec/L kg*s/mL; g*s/uL; s*g/uL; kg*sec/mL; g*sec/uL; sec*g/uL; s*kg/mL mg*s/mL; sec*mg/mL; s*g/L; g*s/L; s*mg/mL

Picograms per minute. Picograms per second. Picomoles per liters per microgram.

Picogram per Minute Picogram per Second Picomole per Liter per Microgram

C85802

s*fg/mL

Seconds times femtograms per milliliter.

Second Times Femtogram per Milliliter

C85803

s*g/mL

Seconds times grams per milliliter.

Second Times Gram per Milliliter

C85804

s*kg/mL

Seconds times kilograms per milliliter.

Second Times Kilogram per Milliliter

C85807

s*mg/mL

Seconds times milligrams per milliliter.

Second Times Milligram per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 414 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym mmol*s/mL; sec*mmol/mL; s*mol/L; mol*s/L; sec*mol/L; mol*sec/L; s*mmol/mL mol*s/mL; sec*mol/mL; mol*sec/mL; s*mol/mL ng*s/mL; sec*ng/mL; ng*sec/mL; s*ug/L; ug*s/L; sec*ug/L; ug*sec/L; s*ng/mL nmol*s/mL; sec*nmol/mL; nmol*sec/mL; s*umol/L; umol*s/L; sec*umol/L; umol*sec/L; s*nmol/mL pg*s/mL; sec*pg/mL; pg*sec/mL; s*ng/L; ng*s/L; sec*ng/L; ng*sec/L; s*pg/mL nmol*s/L; s*nmol/L; sec*pmol/mL; pmol*s/mL; pmol*sec/mL; s*pmol/mL ug*s/mL; s*mcg/mL; ug*sec/mL; sec*ug/mL; sec*mcg/mL; mcg*sec/mL; s*mg/L; mg*s/L umol*s/mL; s*mcmol/mL; sec*umol/mL; umol*sec/mL; mcmol*sec/mL; sec*mcmol/mL; s*mmol/L; mmol*s/L; s*umol/mL

NCI Code C85808

CDISC Submission Value s*mmol/mL

CDISC Definition Seconds times millimoles per milliliter.

NCI Preferred Term Second Times Millimole per Milliliter

C85809

s*mol/mL

Seconds times moles per milliliter.

Second Times Mole per Milliliter

C85810

s*ng/mL

Seconds times nanograms per milliliter.

Second Times Nanogram per Milliliter

C85811

s*nmol/mL

Seconds times nanomoles per milliliter.

Second Times Nanomole per Milliliter

C85812

s*pg/mL

Seconds times picograms per milliliter.

Second Times Picogram per Milliliter

C85813

s*pmol/mL

Seconds times picomoles per milliliter.

Second Times Picomole per Milliliter

C85805

s*ug/mL

Seconds times micrograms per milliliter.

Second Times Microgram per Milliliter

C85806

s*umol/mL

Seconds times micromoles per milliliter.

Second Times Micromole per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 415 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Micro-Internatio nal Unit per milliliter; mIU/L; mcIU/mL; uIU/mL mcL; Microliter; mm3 Microgram; mcg Microgram per Day; mcg/day

NCI Code C67405

CDISC Submission Value uIU/mL

CDISC Definition Microinternational units per milliliter.

NCI Preferred Term Microinternational Unit per Milliliter

C48153 C48152 C71205

uL ug ug/day

A unit of volume accepted for use with the SI and equal to one millionth of a liter (10E-6 liter).(NCI) A unit of mass equal to one millionth of a gram or one thousandth of a milligram.(NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to twenty four hours. Microgram per day is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to twenty four hours.(NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) Micrograms per inhalation. A unit of mass concentration equal to the concentration of one gram of a substance per unit volume of the mixture equal to one cubic meter. The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which mass equal to one gram occupies the volume one cubic meter.(NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to one minute. Microgram per minute is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to one minute.(NCI) Micrograms per puff. Micrograms per second. A unit of amount of substance flow rate equivalent to the rate at which one millionth of a mole of substance travels to a given object or space over a period of time equal to 24 hours.(NCI) Micromoles per hour.

Microliter Microgram Microgram per Day

C67394

ug/h

Micrograms per Hour; mcg/h

Microgram per Hour

C85703 C64572

ug/inh ug/mL

mcg/inh g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter; mcg/mL; ng/uL; ug/mL Micrograms per Minute; mcg/min

Microgram per Inhalation Microgram per Milliliter

C71211

ug/min

Microgram per Minute

C85704 C85705 C67406

ug/puff ug/s umol/day

mcg/puff mcg/sec; mcg/s; ug/sec; ug/s Micromoles per Day; mcmol/day

Microgram per Puff Microgram per Second Micromole per 24 Hours

C85707

umol/h

mcmol/h; umol/h

Micromole per Hour

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 416 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C85494 - PKUNIT - PK Parameter Units of Measure Codelist extensible: Yes
CDISC Synonym Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter; mcmol/mL; mmol/L; nmol/uL mcmol/min; umol/min umol/sec; mcmol/s; mcmol/sec; umol/s

NCI Code C64387

CDISC Submission Value umol/mL

CDISC Definition A unit of concentration (molarity unit) equal to one thousandth of a mole (10E-3 mole) of solute per one liter of solution.(NCI)

NCI Preferred Term Millimole per Liter

C85708 C85709

umol/min umol/s

Micromoles per minute. Micromoles per second.

Micromole per Minute Micromole per Second

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 417 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99075 - PORTOT - Portion/Totality Codelist extensible: Yes
CDISC Synonym

NCI Code C64916 C25326 C17648 C25378 C45312 C48440

CDISC Submission Value ALL ENTIRE MULTIPLE PARTIAL SEGMENT SINGLE

CDISC Definition Being or representing the total number of individual entities. All Whole Many Partial

NCI Preferred Term

Whole Many; Several

Being or representing the complete extent of a single entity. More than one. (NCI) Being or representing an incomplete extent of a single entity. One of the parts into which something is divided. One.

Segment Single

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 418 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71148 - POSITION - Position Codelist extensible: Yes
CDISC Synonym Fowlers

NCI Code C62173

CDISC Submission Value FOWLERS

CDISC Definition A semi-sitting position whereby the head of an adjustable bed is elevated to the desired height, about 60-90 cm, to produce angulation of the body, usually 45 degrees to 60 degrees. Knees may or may not be bent. (NCI) Lying down on one side. A recumbent left lateral side position. (NCI) An anterior recumbent body position whereby the person lies on its stomach and faces downward. (NCI) A supine position with the person inclined at an angle of 45 degrees so that the head is higher than the pelvis. (NCI) A recumbent right lateral side position. (NCI) A semi-sitting or semi-reclined body position whereby the head is elevated on an angle of approximately 30 degrees. (NCI) The state or act of one who sits; the posture of one who occupies a seat. (NCI) A position in which the subject's body is supported by a sling. The act of assuming or maintaining an erect upright position. (NCI) A posterior recumbent body position whereby the person lies on its back and faces upward. (NCI) A supine position with the person inclined at an angle of 45 degrees so that the pelvis is higher than the head. (NCI) The ability to move body parts and limbs without physical restriction. (NCI)

NCI Preferred Term Fowler's Position

C100758 C62172 C62165 C62169

LATERAL DECUBITUS

Lateral Decubitus

Lateral Decubitus Position Left Lateral Decubitus Position Prone Position Reverse Trendelenburg

LEFT LATERAL DECUBITUS Left lateral decubitus PRONE REVERSE TRENDELENBURG RIGHT LATERAL DECUBITUS SEMI-FOWLERS Prone Reverse Trendelenburg Right lateral decubitus Semi-Fowlers

C62171 C62174

Right Lateral Decubitus Position Semi-Fowler's Position

C62122 C92604 C62166 C62167 C62168

SITTING SLING STANDING SUPINE TRENDELENBURG

Sitting Sling Standing Supine Trendelenburg

Sitting Patient in Body Sling Standing Supine Position Trendelenburg

C90480

UNCONSTRAINED

Unconstrained

Unconstrained Body Movement

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 419 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101863 - PROCEDUR - Procedure Codelist extensible: Yes
CDISC Synonym

NCI Code C99907

CDISC Submission Value ABLATION, ACCESSORY PATHWAYS ABLATION, ATRIAL ABLATION, AV NODE ABLATION, VENTRICULAR

CDISC Definition An invasive therapeutic procedure to destroy tissue in an accessory pathways in the atrioventricular conduction system that contributes to arrhythmia. An invasive therapeutic procedure to destroy tissue in the cardiac atria that is the source of an arrhythmia. An invasive therapeutic procedure to destroy tissue in the AV-node that contributes to arrhythmia. An invasive therapeutic procedure to destroy tissue in the cardiac ventricles that is the source of an arrhythmia. Dilation of the valve between the left ventricle of the heart and the aorta by inflating a balloon. Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. aortic valve with a bioprosthetic, homograft, or autograft valve. Repair of atrial septum. An invasive procedure that includes an electronic device that stimulates both right and left cardiac ventricles to improve coordination of ventricular contraction.

NCI Preferred Term Ablation of Cardiac Accessory Pathway Atrial Ablation Ablation of Cardiac Atrioventricular Node Ventricular Ablation

C80432 C99908 C80433

C99916 C50815

AORTIC BALLOON VALVOTOMY AORTIC VALVE REPLACEMENT

Aortic Balloon Valvotomy Aortic Valve Replacement

C99939 C80436

ATRIAL SEPTAL CLOSURE CARDIAC RESYNCHRONIZATION THERAPY CARDIAC TRANSPLANT Heart Transplant

Closure of Cardiac Atrial Septum Cardiac Resynchronization Therapy

C15246

A surgical procedure in which a damaged heart is removed and replaced by another heart from a suitable donor. The administration of pharmacologic agents to correct abnormal heart rhythm. The administration of electric current to correct abnormal heart rhythm. Surgery performed to bypass partially or completely occluded coronary arteries, thereby increasing the blood supply of the heart.

Heart Transplantation

C99937

CARDIOVERSION, CHEMICAL CARDIOVERSION, ELECTRICAL CORONARY ARTERY BYPASS GRAFT

CHEMICAL CARDIOVERSI ON ELECTRICAL CARDIOVERSI ON CAB; CABG; Coronary Artery Bypass Graft; Coronary Artery Bypass Grafting; Heart Bypass; Aortocoronary Bypass; Coronary Artery Bypass; Coronary Artery Bypass Graft Surgery Implantable Cardioverter Defibrillator Procedure Lead Procedure

Chemical Cardioversion

C99948

Electric Cardioversion

C51998

Heart Bypass

C80435

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD

A procedure involving an electronic device implanted in the body that delivers electrical stimulation to the heart to treat tachycardia. It may also have the capability to treat bradycardia. A procedure involving one or more wires used for pacemaker or implantable defibrillator devices.

Implantable Cardioverter-Defibrillator Placement Cardiac Lead Procedure

C99934

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 420 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101863 - PROCEDUR - Procedure Codelist extensible: Yes
CDISC Synonym

NCI Code C99965 C80473

CDISC Submission Value LEFT ATRIAL APPENDAGE OCCLUSION LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION EVALUATION MITRAL BALLOON VALVOTOMY MITRAL COMMISSUROTOMY MITRAL VALVE REPAIR MITRAL VALVE REPLACEMENT

CDISC Definition The therapeutic blockage of the muscular pouch in the left atrium.

NCI Preferred Term Intentional Left Cardiac Atrial Appendage Occlusion Procedure Left Ventricular Assist Device

LVAD

A procedure involving a mechanical cardiac pump which receives blood from the left ventricle and delivers it to the aorta. An examination and assessment of the inability of the left ventricle to effectively pump blood to the body. Dilation of the valve between the left atrium and the left ventricle of the heart by inflating a balloon. Dilation of the valve between the left atrium and the left ventricle of the heart by use of a surgeon's finger or rigid instrument. Surgery performed for the purpose of reducing regurgitation of the mitral valve. Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. mitral valve with bioprosthetic, homograft or autograft valve. An operative procedure that does not involve the heart or the blood vessels.

C99975

Left Cardiac Ventricular Systolic Dysfunction Evaluation Mitral Balloon Valvotomy Mitral Commissurotomy

C99987 C99988

C80449 C50825

Mitral Valve Repair Mitral Valve Replacement

C99995 C99998

NON-CARDIOVASCULAR SURGERY PACEMAKER Pacemaker Procedure PCI

Non-Cardiovascular Surgery Pacemaker Procedure

A procedure involving an electronic device that delivers electrical stimulation to the heart to treat bradycardia. A procedure on the coronary arteries of the heart that is performed by the placement of an angioplasty guide wire, balloon, or other device (e.g. stent, atherectomy, brachytherapy, or thrombectomy catheter) into a native coronary artery or coronary artery bypass graft for the purpose of mechanical coronary revascularization. Invasive procedure through a puncture in the skin, performed for the purpose of reducing regurgitation of the mitral valve. Removal or resection of the pericardium. A procedure in which an opening is made in the pericardium. The aspiration of excess fluid between the pericardium and the heart. Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. pulmonary valve with bioprosthetic, homograft or autograft valve. Dilation of the valve between the right ventricle and the pulmonary artery of the heart by inflating a balloon.

C99521

PERCUTANEOUS CORONARY INTERVENTION

Percutaneous Coronary Intervention

C100003

PERCUTANEOUS MITRAL REPAIR PERICARDIAL STRIPPING PERICARDIAL WINDOW PERICARDIOCENTESIS PULMONARY VALVE REPLACEMENT

Percutaneous Mitral Valve Repair

C100004 C51618 C52010 C50817

Pericardial Stripping Pericardial Window Procedure Pericardiocentesis Pulmonary Valve Replacement

C100044 C100010

PULMONIC VALVULOPLASTY RIGHT VENTRICULAR ASSIST DEVICE RVAD

Pulmonic Valvuloplasty Right Cardiac Ventricle Assist Device Procedure

A procedure involving a mechanical pump which receives blood from the right ventricle and delivers it to the pulmonary artery.

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 421 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101863 - PROCEDUR - Procedure Codelist extensible: Yes
CDISC Synonym

NCI Code C80439

CDISC Submission Value SEPTAL ABLATION

CDISC Definition A cardiac catheterization procedure to relieve symptoms in patients with severe obstructive hypertrophic cardiomyopathy. A catheter is used to inject alcohol into a septal artery supplying the heart muscle responsible for the obstruction, destroying the muscle tissue and relieving the obstruction.

NCI Preferred Term Septal Ablation

C100017

SURGICAL MAZE

Cox Maze

A cardiac procedure intended to inhibit atrial fibrillation, in which a series of incisions are made in the atria to block abnormal electrical circuits that contribute to atrial fibrillation. Use of a thin tube to deliver an artificial valve apparatus between the left ventricle of the heart and the aorta. Surgery performed for the purpose of reducing regurgitation of the cardiac valve between the right atrium and right ventricle. Surgery performed with the purpose of replacing a degenerated, calcified, malformed, dysfunctional, etc. tricuspid valve with bioprosthetic, homograft or autograft valve. Cardiac surgical procedure performed for the removal of an aneurysm from the ventricular wall. Repair of ventricular septum.

Surgical Maze Procedure

C100022

TRANSCATHETER AORTIC VALVE IMPLANT TRICUSPID VALVE REPAIR

Transcatheter Aortic Valve Implantation Cardiac Tricuspid Valve Repair

C99935

C50816

TRICUSPID VALVE REPLACEMENT

Tricuspid Valve Replacement

C80451 C99940

VENTRICULAR ANEURYSM RESECTION VENTRICULAR SEPTAL CLOSURE

Ventricular Aneurysm Resection Closure of Cardiac Ventricle Septum

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 422 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101864 - PRURGNCY - Procedure Urgency Status Codelist extensible: No
CDISC Synonym

NCI Code C51996

CDISC Submission Value ELECTIVE

CDISC Definition Elective procedures can be deferred without increased risk of compromised outcome. Patient's clinical condition is currently stable and has been stable in the days/weeks prior. The clinical situation does not demand that the procedure take place at a specified time. Emergency procedures must be performed as soon as possible because of substantial concerns that delay could lead to death. Clinical situation demands that procedure should be performed immediately or in next available room, even if it means another case must be rescheduled. Performing a salvage procedure is the last resort. The clinical situation involves either ongoing life support measures, life support measures for more than 60 seconds during the prior 10 minutes, or unanticipated institution of extracorporeal circulatory support. Deferring an urgent procedure increases risk of adverse outcome or clinical deterioration. Clinical situation warrants performing urgent procedures during the current episode of care to avoid compromising patient safety.

NCI Preferred Term Elective Surgical Procedure

C62648

EMERGENCY

Emergency

C15359

SALVAGE

Salvage Therapy

C100031

URGENT

Urgent Procedure

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 423 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74457 - RACE - Race Codelist extensible: Yes
CDISC Synonym

NCI Code C41259

CDISC Submission Value AMERICAN INDIAN OR ALASKA NATIVE

CDISC Definition A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment. (FDA) A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (FDA)

NCI Preferred Term American Indian or Alaska Native

C41260

ASIAN

Asian

C16352

BLACK OR AFRICAN AMERICAN

A person having origins in any of the black racial African American groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American." (FDA) Denotes a person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. The term covers particularly people who identify themselves as part-Hawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian, Samoan, Chuu. (FDA) Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White. (FDA) Native Hawaiian or Other Pacific Islander

C41219

NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

C41261

WHITE

White

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 424 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C100130 - RELSUB - Relationship to Subject Codelist extensible: Yes
CDISC Synonym Biological Aunt

NCI Code C96569

CDISC Submission Value AUNT, BIOLOGICAL

CDISC Definition A female relative who is a sibling of either of the biological parents, and who share a common ancestor. (NCI) A female relative who is a sibling of the biological mother, and who both share a common ancestor. (NCI) A female relative who is a sibling of the biological father, and who both share a common ancestor. (NCI) A male who shares with his sibling the genetic makeup inherited from one or both of their shared biological parents. A male who shares with his sibling the genetic makeup inherited from only the biological mother. A male who shares with his sibling the genetic makeup inherited from only the biological father. A male who shares with his sibling the genetic makeup inherited from only one of the biological parents. The primary person in charge of the care of a patient, usually a family member or a designated health care professional. (NCI) A son or daughter with genetic makeup inherited from the parent. An individual, such as a physician, nurse practitioner or other health care professional, who takes responsibility for a subject's care. A relative who is the offspring of a sibling of either of the biological parents, and who share a common ancestor. (NCI) A relative who is the offspring of a sibling of the biological mother and share a common ancestor. A relative who is the offspring of a sibling of the biological father and share a common ancestor. Person declares that a domestic partnership relationship exists. (HL7) One that contributes something. (NCI) Someone from whom an organ is removed for transplantation or other purpose. Someone from whom tissue is removed for transplantation or other purpose. Any of the individuals who are descended from a common progenitor, related by marriage or other legal tie. A male who contributes to the genetic makeup of his offspring through the fertilization of an ovum by his sperm. (NCI)

NCI Preferred Term Biological Aunt

C96575 C96581 C96570

AUNT, BIOLOGICAL MATERNAL AUNT, BIOLOGICAL PATERNAL BROTHER, BIOLOGICAL

Biological Maternal Aunt Biological Paternal Aunt Biological Brother Half-brother with Mother as Common Parent Half-brother with Father as Common Parent Half Brother Caregiver

Biological Maternal Aunt Biological Paternal Aunt Biological Brother

C96656

BROTHER, BIOLOGICAL MATERNAL HALF BROTHER, BIOLOGICAL PATERNAL HALF BROTHER, HALF CAREGIVER

Half-brother with Mother as Common Parent Half-brother with Father as Common Parent Half Brother Caregiver

C96655

C71402 C17445

C100807 C85499

CHILD, BIOLOGICAL CLINICIAN

Biological Child Clinician

Biological Child Clinician

C96571

COUSIN, BIOLOGICAL

Biological Cousin Biological Maternal Cousin Biological Paternal Cousin Domestic Partner Donor Organ Donor Tissue Donor Family Member

Biological Cousin

C96576 C96582 C53262 C48284 C100810 C25168 C41256

COUSIN, BIOLOGICAL MATERNAL COUSIN, BIOLOGICAL PATERNAL DOMESTIC PARTNER DONOR DONOR, ORGAN DONOR, TISSUE FAMILY MEMBER

Biological Maternal Cousin Biological Paternal Cousin Domestic Partnership Donor Organ Donor Tissue Donor Family Member

C96572

FATHER, BIOLOGICAL

Biological Father

Biological Father

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 425 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C100130 - RELSUB - Relationship to Subject Codelist extensible: Yes
CDISC Synonym Biological Grandchild Biological Grandfather Biological Maternal Grandfather Biological Paternal Grandfather Biological Grandmother Biological Maternal Grandmother Biological Paternal Grandmother Biological Grandparent Biological Mother Nurse Pregnancy Partner First Degree Relative Second Degree Relative

NCI Code C100805 C96573 C96577

CDISC Submission Value GRANDCHILD, BIOLOGICAL GRANDFATHER, BIOLOGICAL GRANDFATHER, BIOLOGICAL MATERNAL GRANDFATHER, BIOLOGICAL PATERNAL GRANDMOTHER, BIOLOGICAL GRANDMOTHER, BIOLOGICAL MATERNAL GRANDMOTHER, BIOLOGICAL PATERNAL GRANDPARENT, BIOLOGICAL MOTHER, BIOLOGICAL NURSE PREGNANCY PARTNER RELATIVE, FIRST DEGREE

CDISC Definition A biological child of an individual's biological child. A male relative who is the biological father of either the biological mother or the biological father. (NCI) A male relative who is the biological father of the biological mother. (NCI) A male relative who is the biological father of the biological father. (NCI) A female relative who is the biological mother of either the biological mother or the biological father. (NCI) A female relative who is the biological mother of the biological mother. (NCI) A female relative who is the biological mother of the biological father. (NCI) A biological parent of the biological father or biological mother. A female who contributes to the genetic makeup of her offspring from the fertilization of her ovum. (NCI) A professional healthcare provider who has graduated from a nursing program. An individual who provides support to a pregnant individual. Any individual related biologically or legally to another individual and considered immediate family as in the case of a spouse, parent, sibling or child. Any individual related biologically or legally to another individual and considered one degree removed from the immediate family as in the case of in-laws, grandparents, aunts and uncles. Any individual related biologically or legally to another individual and considered two degrees removed from the immediate family as in the case of cousins. A person with whom one has had sexual relations. A person's brother or sister with whom they share a genetic makeup inherited from their shared biological parents. A female who shares with her sibling the genetic makeup inherited from one or both of their shared biological parents. A female who shares with her sibling the genetic makeup inherited from only the biological mother.

NCI Preferred Term Biological Grandchild Biological Grandfather Biological Maternal Grandfather

C96583

Biological Paternal Grandfather

C96574

Biological Grandmother

C96578

Biological Maternal Grandmother

C96584

Biological Paternal Grandmother

C100806 C96580 C20821 C100811 C21481

Biological Grandparent Biological Mother Nurse Pregnancy Partner First Degree Relative

C19811

RELATIVE, SECOND DEGREE

Second Degree Relative

C100808

RELATIVE, THIRD DEGREE Third Degree Relative

Third Degree Relative

C100812 C100809

SEXUAL PARTNER SIBLING, BIOLOGICAL

Sexual Partner Biological Sibling Biological Sister

Sexual Partner Biological Sibling

C96586

SISTER, BIOLOGICAL

Biological Sister

C96658

SISTER, BIOLOGICAL MATERNAL HALF

Half-sister with Mother as Common Parent

Half-sister with Mother as Common Parent

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 426 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C100130 - RELSUB - Relationship to Subject Codelist extensible: Yes
CDISC Synonym Half-sister with Father as Common Parent Half Sister

NCI Code C96657

CDISC Submission Value SISTER, BIOLOGICAL PATERNAL HALF SISTER, HALF

CDISC Definition A female who shares with her sibling the genetic makeup inherited from only the biological father. A female who shares with her sibling the genetic makeup inherited from only one of the biological parents. A person's partner in marriage. (NCI) A person skilled in the performance of the technical or procedural aspects of a profession. (NCI) Either of two offspring born from the same pregnancy. (NCI) Either of the two offspring resulting from two separately fertilized ovums during the same pregnancy. Either of the two offspring resulting from a shared ovum. (NCI) A male relative who is a sibling of either of the biological parents, and who share a common ancestor. (NCI) A male relative who is a sibling of the biological mother, and who both share a common ancestor. (NCI) A male relative who is a sibling of the biological father, and who both share a common ancestor. (NCI)

NCI Preferred Term Half-sister with Father as Common Parent Half Sister

C71403

C62649 C63861 C73427 C73428 C73429 C96587

SPOUSE TECHNICIAN TWIN TWIN, DIZYGOTIC TWIN, MONOZYGOTIC UNCLE, BIOLOGICAL

Spouse Technician Twin Dizygotic Twin Monozygotic Twin Biological Uncle

Spouse Technician Twin Fraternal Twin Identical Twin Biological Uncle

C96579 C96585

UNCLE, BIOLOGICAL MATERNAL UNCLE, BIOLOGICAL PATERNAL

Biological Maternal Uncle Biological Paternal Uncle

Biological Maternal Uncle Biological Paternal Uncle

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 427 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78737 - RELTYPE - Relationship Type Codelist extensible: No
CDISC Synonym Many; Several

NCI Code C78728 C66832

CDISC Submission Value MANY ONE

CDISC Definition More than one. (NCI) A textual representation of the numeral 1. Many One

NCI Preferred Term

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 428 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66729 - ROUTE - Route of Administration Codelist extensible: Yes
CDISC Synonym

NCI Code C38192 C38193 C38194

CDISC Submission Value AURICULAR (OTIC) BUCCAL CONJUNCTIVAL

CDISC Definition Administration to or by way of the ear. (FDA) Administration directed toward the cheek, generally from within the mouth. (FDA) Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball. (FDA) Administration to the skin. (FDA) Administration to a tooth or teeth. (FDA) Administration by way of food stuff. (NCI) Administration of through the diffusion of substance through a membrane in an electric field. (FDA) Administration within the canal of the cervix uteri. Synonymous with the term intracervical. (FDA) Administration within the nasal sinuses of the head. (FDA)

NCI Preferred Term Auricular Route of Administration Buccal Route of Administration Conjunctival Route of Administration Cutaneous Route of Administration Dental Route of Administration Dietary Route of Administration Electro-osmosis Route of Administration Endocervical Route of Administration Endosinusial Route of Administration Endotracheal Route of Administration Enteral Route of Administration Epidural Route of Administration Extraamniotic Route of Administration Extracorporeal Circulation Route of Administration Administration Via Hemodialysis Infiltration Route of Administration Interstitial Route of Administration Intraabdominal Route of Administration Intraamniotic Route of Administration Intraarterial Route of Administration Intraarticular Route of Administration Intrabiliary Route of Administration Intrabronchial Route of Administration Intrabursal Route of Administration Intracardiac Route of Administration

C38675 C38197 C78373 C38633 C38205 C38206 C38208

CUTANEOUS DENTAL DIETARY ELECTRO-OSMOSIS ENDOCERVICAL ENDOSINUSIAL ENDOTRACHEAL Intratracheal Route of Administration

Administration directly into the trachea. Synonymous with the term intratracheal. (FDA) Administration directly into the intestines. (FDA) Administration upon or over the dura mater. (FDA) Administration to the outside of the membrane enveloping the fetus. (FDA) Administration outside of the body. (FDA) Administration through hemodialysate fluid. (FDA) Administration that results in substances passing into tissue spaces or into cells. (FDA) Administration to or in the interstices of a tissue. (FDA) Administration within the abdomen. (FDA) Administration within the amnion. (FDA) Administration within an artery or arteries. (FDA) Administration within a joint. (FDA) Administration within the bile, bile ducts or gallbladder. (FDA) Administration within a bronchus. (FDA) Administration within a bursa. (FDA) Administration within the heart. (FDA)

C38209 C38210 C38211 C38212 C38200 C38215 C38219 C38220 C38221 C38222 C38223 C38224 C38225 C38226 C38227

ENTERAL EPIDURAL EXTRA-AMNIOTIC EXTRACORPOREAL HEMODIALYSIS INFILTRATION INTERSTITIAL INTRA-ABDOMINAL INTRA-AMNIOTIC INTRA-ARTERIAL INTRA-ARTICULAR INTRABILIARY INTRABRONCHIAL INTRABURSAL INTRACARDIAC

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 429 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66729 - ROUTE - Route of Administration Codelist extensible: Yes
CDISC Synonym

NCI Code C38228 C38229 C38230 C38231

CDISC Submission Value INTRACARTILAGINOUS INTRACAUDAL INTRACAVERNOUS INTRACAVITARY

CDISC Definition Administration within a cartilage; endochondral. (FDA) Administration within the cauda equina. (FDA) Administration within a pathologic cavity, such as occurs in the lung in tuberculosis. (FDA) Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that is formed as the result of a wound. (FDA) Administration within the cerebrum. (FDA) Administration within the cisterna magna cerebellomedularis. (FDA) Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye). (FDA) Administration of a drug within a portion of a tooth which is covered by enamel and which is separated from the roots by a slightly constricted region known as the neck. (FDA) Administration within the coronary arteries. (FDA) Administration within the dilatable spaces of the corporus cavernosa of the penis. (FDA) Administration within the dermis. (FDA) Administration within a disc. (FDA) Administration within the duct of a gland. (FDA) Administration within the duodenum. (FDA) Administration within or beneath the dura. (FDA) Administration within the epidermis. (FDA) Administration within the esophagus. (FDA) Administration within the stomach. (FDA) Administration within the gingivae. (FDA) Administration within the distal portion of the small intestine, from the jejunum to the cecum. (FDA) Administration into the jejunum. Administration within or introduced directly into a localized lesion. (FDA) Administration within the lumen of a tube. (FDA) Administration within the lymph. (FDA)

NCI Preferred Term Intracartilaginous Route of Administration Intracaudal Route of Administration Intracavernous Route of Administration Intracavitary Route of Administration

C38232 C38233 C38234

INTRACEREBRAL INTRACISTERNAL INTRACORNEAL

Intracerebral Route of Administration Intracisternal Route of Administration Intracorneal Route of Administration

C38217

INTRACORONAL, DENTAL

Intracoronal Dental Route of Administration

C38218 C38235 C38238 C38239 C38240 C38241 C38242 C38243 C38245 C38246 C38247 C38249 C102399 C38250 C38251 C38252

INTRACORONARY INTRACORPORUS CAVERNOSUM INTRADERMAL INTRADISCAL INTRADUCTAL INTRADUODENAL INTRADURAL INTRAEPIDERMAL INTRAESOPHAGEAL INTRAGASTRIC INTRAGINGIVAL INTRAILEAL INTRAJEJUNAL INTRALESIONAL INTRALUMINAL INTRALYMPHATIC

Intracoronary Route of Administration Intracorporus Cavernosum Route of Administration Intradermal Route of Administration Intradiscal Route of Administration Intraductal Route of Administration Intraduodenal Route of Administration Intradural Route of Administration Intraepidermal Route of Administration Intraesophageal Route of Administration Intragastric Route of Administration Intragingival Route of Administration Intraileal Route of Administration Intrajejunal Route of Administration Intralesional Route of Administration Intraluminal Route of Administration Intralymphatic Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 430 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66729 - ROUTE - Route of Administration Codelist extensible: Yes
CDISC Synonym

NCI Code C38253 C38254

CDISC Submission Value INTRAMEDULLARY INTRAMENINGEAL

CDISC Definition Administration within the marrow cavity of a bone. (FDA) Administration within the meninges (the three membranes that envelope the brain and spinal cord). (FDA) Administration within a muscle. (FDA) Administration within the eye. (FDA) Administration within the ovary. (FDA) Administration into the palate. Administration within the pericardium. (FDA) Administration within the peritoneal cavity. (FDA) Administration within the pleura. (FDA) Administration within the prostate gland. (FDA) Administration within the lungs or its bronchi. (FDA) Administration within the nasal or periorbital sinuses. (FDA) Administration within the vertebral column. (FDA) Administration into a stoma. Administration within the synovial cavity of a joint. (FDA) Administration within a tendon. (FDA) Administration within the testicle. (FDA) Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles. (FDA) Administration within the thorax (internal to the ribs); synonymous with the term endothoracic. (FDA) Administration within the tubules of an organ. (FDA)

NCI Preferred Term Intramedullary Route of Administration Intrameningeal Route of Administration Intramuscular Route of Administration Intraocular Route of Administration Intraovarian Route of Administration Intrapalatal Route of Administration Intrapericardial Route of Administration Intraperitoneal Route of Administration Intrapleural Route of Administration Intraprostatic Route of Administration Intrapulmonary Route of Administration Intrasinal Route of Administration Intraspinal Route of Administration Administration via Stoma Intrasynovial Route of Administration Intratendinous Route of Administration Intratesticular Route of Administration Intrathecal Route of Administration

C28161 C38255 C38256 C102400 C38257 C38258 C38259 C38260 C38261 C38262 C38263 C65138 C38264 C38265 C38266 C38267

INTRAMUSCULAR INTRAOCULAR INTRAOVARIAN INTRAPALATAL INTRAPERICARDIAL INTRAPERITONEAL INTRAPLEURAL INTRAPROSTATIC INTRAPULMONARY INTRASINAL INTRASPINAL INTRASTOMAL INTRASYNOVIAL INTRATENDINOUS INTRATESTICULAR INTRATHECAL

C38207 C38268 C38269

INTRATHORACIC INTRATUBULAR INTRATUMOR Intratumor Route of Administration

Endothoracic Route of Administration Intratubular Route of Administration Intratumoral Route of Administration

Administration within a tumor. (FDA)

C38270 C38272 C38273

INTRATYMPANIC INTRAUTERINE INTRAVASCULAR

Administration within the auris media. (FDA) Administration within the uterus. (FDA) Administration within a vessel or vessels. (FDA)

Intratympanic Route of Administration Intrauterine Route of Administration Intravascular Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 431 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66729 - ROUTE - Route of Administration Codelist extensible: Yes
CDISC Synonym

NCI Code C38276 C38274 C38279 C38277 C38278 C38280 C38203

CDISC Submission Value INTRAVENOUS INTRAVENOUS BOLUS INTRAVENOUS DRIP INTRAVENTRICULAR INTRAVESICAL INTRAVITREAL IONTOPHORESIS

CDISC Definition Administration within or into a vein or veins. (FDA) Administration within or into a vein or veins all at once. (FDA) Administration within or into a vein or veins over a sustained period of time. (FDA) Administration within a ventricle. (FDA) Administration within the bladder. (FDA) Administration within the vitreous body of the eye. (FDA) Administration by means of an electric current where ions of soluble salts migrate into the tissues of the body. (FDA) Administration to bathe or flush open wounds or body cavities. (FDA) Administration directly upon the larynx. (FDA)

NCI Preferred Term Intravenous Route of Administration Intravenous Bolus Intravenous Drip Intraventricular Route of Administration Intravesical Route of Administration Intravitreal Route of Administration Iontophoresis Route of Administration Irrigation-Route of Administration Laryngeal Route of Administration Nasal Route of Administration

C38281 C38282 C38284

IRRIGATION LARYNGEAL NASAL Intranasal Route of Administration

Administration to the nose; administered by way of the nose. (FDA) Administration through the nose and into the stomach, usually by means of a tube. (FDA) Routes of administration are not applicable. (FDA) Administration by the topical route which is then covered by a dressing which occludes the area. (FDA) Administration to the external eye. (FDA)

C38285 C48623 C38286 C38287 C38288

NASOGASTRIC NOT APPLICABLE OCCLUSIVE DRESSING TECHNIQUE OPHTHALMIC ORAL PO; Intraoral Route of Administration

Nasogastric Route of Administration Route of Administration Not Applicable Occlusive Dressing Technique Ophthalmic Route of Administration Oral Route of Administration

Administration to or by way of the mouth. (FDA)

C78374 C38289 C38290 C38291 C38676 C38292 C38677 C38293

ORAL GAVAGE OROPHARYNGEAL OTHER PARENTERAL PERCUTANEOUS PERIARTICULAR PERIDURAL PERINEURAL

Administration through the mouth and into the stomach, usually by means of a tube. (NCI) Administration directly to the mouth and pharynx. (FDA) Administration is different from others on this list. (FDA) Administration by injection, infusion, or implantation. (FDA) Administration through the skin. (FDA) Administration around a joint. (FDA) Administration to the outside of the dura mater of the spinal cord. (FDA) Administration surrounding a nerve or nerves. (FDA)

Oral Gavage Route of Administration Oropharyngeal Route of Administration Other Route of Administration Parenteral Route of Administration Percutaneous Route of Administration Periarticular Route of Administration Peridural Route of Administration Perineural Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 432 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66729 - ROUTE - Route of Administration Codelist extensible: Yes
CDISC Synonym

NCI Code C38294 C38295 C38216 C38296 C38198 C38297 C38298 C38299 C38300 C38301 C38304

CDISC Submission Value PERIODONTAL RECTAL RESPIRATORY (INHALATION) RETROBULBAR SOFT TISSUE SUBARACHNOID SUBCONJUNCTIVAL SUBCUTANEOUS SUBLINGUAL SUBMUCOSAL TOPICAL SC

CDISC Definition Administration around a tooth. (FDA) Administration to the rectum. (FDA) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) Administration behind the pons or behind the eyeball. (FDA) Administration into any soft tissue. (FDA) Administration beneath the arachnoid. (FDA) Administration beneath the conjunctiva. (FDA) Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) Administration beneath the tongue. (FDA) Administration beneath the mucous membrane. (FDA)

NCI Preferred Term Periodontal Route of Administration Rectal Route of Administration Inhalation Route of Administration Retrobulbar Route of Administration Soft Tissue Route Of Administration Subarachnoid Route of Administration Subconjunctival Route of Administration Subcutaneous Route of Administration Sublingual Route of Administration Submucosal Route of Administration Topical Route of Administration

TOP

Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. (FDA) Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Administration across the mucosa. (FDA) Administration through or across the placenta. (FDA) Administration through the wall of the trachea. (FDA) Administration across or through the tympanic cavity. (FDA) Route of administration has not yet been assigned. (FDA) Route of administration is unknown. (FDA) Administration into the ureter. (FDA) Administration into the urethra. (FDA) Administration into the vagina. (FDA)

C38305 C38283 C38307 C38308 C38309 C38310 C38311 C38312 C38271 C38313

TRANSDERMAL TRANSMUCOSAL TRANSPLACENTAL TRANSTRACHEAL TRANSTYMPANIC UNASSIGNED UNKNOWN URETERAL URETHRAL VAGINAL

Transdermal Route of Administration Mucosal Route of Administration Transplacental Route of Administration Transtracheal Route of Administration Transtympanic Route of Administration Unassigned Route of Administration Unknown Route of Administration Ureteral Route of Administration Intraurethral Route of Administration Vaginal Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 433 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101865 - RSKASMT - Risk Assessment Codelist extensible: No
CDISC Synonym

NCI Code C102401

CDISC Submission Value HIGH RISK

CDISC Definition The potential future harm that may arise from some present action or attribute or condition is almost certain. The potential future harm that may arise from some present action or attribute or condition is moderate. The potential future harm that may arise from some present action or attribute or condition is small. Not known, not observed, not recorded, or refused. (NCI)

NCI Preferred Term High Risk

C102402 C102403 C17998

INTERMEDIATE RISK LOW RISK UNKNOWN

Intermediate Risk Low Risk Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 434 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96785 - RSSTRESC - Tumor Response Result Codelist extensible: Yes
CDISC Synonym Complete Response Not Applicable Not Evaluable Non Complete Response/Non Progressive Disease Progressive Disease Partial Response

NCI Code C4870 C48660 C62222 C96700

CDISC Submission Value CR NA NE NonCR/NonPD

CDISC Definition The disappearance of all signs of cancer in response to treatment. (NCI) Determination of a value is not relevant in the current context. (NCI) Unable to be evaluated. (NCI) Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above the normal limits. (RECIST) A disease process that is increasing in scope or severity. (NCI) A finding indicating that there is a decrease in the size and the extent of tissue involvement by a malignant tumor in a patient. (NCI) Cancer that is neither decreasing nor increasing in extent or severity. (NCI) An overall level of substantial worsening in non-target disease that is of a magnitude that, even in the presence of SD or PR in target disease, the treating physician would feel it important to change therapy. (RECIST)

NCI Preferred Term Complete Remission Not Applicable Unevaluable Non Complete Response/Non Progressive Disease

C35571 C18058

PD PR

Progressive Disease Partial Remission

C18213 C96644

SD UPD

Stable Disease Unequivocal Progression

Stable Disease Unequivocal Progression

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 435 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96781 - RSTEST - Tumor Response Assessment Test Name Codelist extensible: Yes
CDISC Synonym Best Overall Response; Best Response Non-Radiologica l Progression Non-target Response Overall Response Target Response

NCI Code C94536

CDISC Submission Value Best Overall Response

CDISC Definition An assessment of the most clinically favorable overall response of the disease to the therapy. A non-radiological determination of disease progression based on symptoms or other findings. An assessment of the response of a non-target tumor(s) to the therapy. An assessment of the overall response of the disease to the therapy. (NCI) An assessment of the response of a target tumor(s) to the therapy.

NCI Preferred Term Best Overall Response

C96608 C96609 C96613 C96637

Non-Radiological Progression Non-target Response Overall Response Target Response

Non-Radiological Progression Non-target Response Overall Response Target Response

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 436 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96782 - RSTESTCD - Tumor Response Assessment Test Code Codelist extensible: Yes
CDISC Synonym Best Overall Response; Best Response Non-Radiologica l Progression Non-target Response Overall Response Target Response

NCI Code C94536

CDISC Submission Value BESTRESP

CDISC Definition An assessment of the most clinically favorable overall response of the disease to the therapy. A non-radiological determination of disease progression based on symptoms or other findings. An assessment of the response of a non-target tumor(s) to the therapy. An assessment of the overall response of the disease to the therapy. (NCI) An assessment of the response of a target tumor(s) to the therapy.

NCI Preferred Term Best Overall Response

C96608 C96609 C96613 C96637

NRADPROG NTRGRESP OVRLRESP TRGRESP

Non-Radiological Progression Non-target Response Overall Response Target Response

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 437 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74559 - SCCD - Subject Characteristic Code Codelist extensible: Yes
CDISC Synonym Education Level Employee Job

NCI Code C17953 C25193

CDISC Submission Value EDLEVEL EMPJOB

CDISC Definition Years of education that a person has completed. A code specifying the job performed by the employee for the employer. For example, accountant, programmer analyst, patient care associate, staff nurse, etc. A code qualifying the employment in various ways, such as, full-time vs. part time, etc. A demographic parameter indicating a person's current conjugal status. A code specifying the method used by the employer to compute the employee's salary or wages. For example, hourly, annual, or commission. A classification system used to categorize the sensitivity of a subject's skin to sunlight. A distinctive characteristic of the skin marked by the amount of sebum secreted by sebaceous glands.

NCI Preferred Term Education Level Occupation

C74565 C25188 C74566

JOBCLAS MARISTAT SALTYP

Employee Job Class Marital Status Employee Salary Type Skin Classification Skin Type

Employee Job Class Marital Status Employee Salary Type

C74563 C74580

SKINCLAS SKINTYP

Fitzpatrick Classification Scale Skin Type

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 438 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101866 - SDTHSDTP - Sudden Death Syndrome Type Codelist extensible: No
CDISC Synonym Ventricular arrhythmia associated with Brugada syndrome

NCI Code C71059

CDISC Submission Value BRUGADA SYNDROME

CDISC Definition Polymorphic ventricular tachycardia in the absence of structural heart disease, associated with a baseline ECG pattern during sinus rhythm showing right bundle branch block with ST segment elevation in leads V1 through V3. It can also be characterized by documentation of ECG patterns associated with Brugada Syndrome, some of which may be unmasked when provoked with drugs. The most common genetic mutations identified for Brugada syndrome are in the sodium channel gene SCN5A. Ventricular Tachycardia associated with syncope and/or cardiac arrest triggered by emotion or exercise in patients whose baseline ECG is normal. Ventricular tachycardia or ventricular fibrillation whose cause is unknown.

NCI Preferred Term Brugada Syndrome

C99936

CATECHOLAMINERGIC POLYMORPHIC VENTRICULAR TACHYCARDIA IDIOPATHIC PRIMARY VENTRICULAR TACHYCARDIA/ VENTRICULAR FLUTTER LONG QT SYNDROME Ventricular arrhythmia associated with long QT syndrome

Catecholaminergic Polymorphic Ventricular Tachycardia

C100036

Idiopathic Primary Ventricular Tachycardia Ventricular Flutter

C34786

Long QT Syndrome includes prolongation of the corrected QT interval beyond 440 ms for adult males, 460 ms for adult females and 50 ms in the presence of ventricular depolarization abnormalities (i.e., bundle branch blocks or IVCB more than 120 ms. A normal QT interval in a resting ECG with a failure to shorten with an increase in heart rate qualifies as Long QT Syndrome. Different than the one(s) previously specified or mentioned. (NCI) Short QT Syndrome is characterized by a QT interval of less than or equal to 300 ms.

Long QT Syndrome

C17649 C71060

OTHER SHORT QT SYNDROME

Other Ventricular arrhythmia associated with short QT syndrome

Other Short QT Syndrome

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 439 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66731 - SEX - Sex Codelist extensible: No
CDISC Synonym Female

NCI Code C16576 F

CDISC Submission Value

CDISC Definition A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI) A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. (NCI) Not known, not observed, not recorded, or refused. (NCI) A person (one of unisexual specimens) who is born with genitalia and/or secondary sexual characteristics of indeterminate sex, or which combine features of both sexes. (NCI) Female

NCI Preferred Term

C20197

Male

Male

C17998 C45908

U UN

U; Unknown Undifferentiated

Unknown Intersex

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 440 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66732 - SEXPOP - Sex of Participants Codelist extensible: No
CDISC Synonym

NCI Code C49636 C16576

CDISC Submission Value BOTH F

CDISC Definition One and the other; relating to or being two in conjunction. (NCI) Both Female

NCI Preferred Term

Female

A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI) A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. (NCI)

C20197

Male

Male

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 441 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66733 - SIZE - Size Codelist extensible: Yes
CDISC Synonym

NCI Code C49508 C49507 C25376

CDISC Submission Value LARGE MEDIUM SMALL

CDISC Definition Of considerable or relatively great size, extent, or capacity. (NCI) Mid-way between small and large in number, quantity, magnitude or extent. (NCI) Limited in number, quantity, magnitude or extent. (NCI) Large

NCI Preferred Term

Medium Small

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 442 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C76351 - SKINCLAS - Skin Classification Codelist extensible: Yes
CDISC Synonym TYPE1

NCI Code C74569

CDISC Submission Value TYPEI

CDISC Definition Individuals who never tan and always sunburn if exposed to any appreciable amount of sunlight, primarily red headed individuals and lightly complected blondes. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) Individuals who frequently burn but are able to tan to a small degree after extended sun exposure. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) Individuals who burn infrequently and tan readily. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) Individuals who rarely burn and tan heavily with moderate sun exposures, especially individuals of Asian, American Indian, Mediterranean and Latin American descent. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871)

NCI Preferred Term Fitzpatrick Skin Type I

C74570

TYPEII

TYPE2

Fitzpatrick Skin Type II

C74571

TYPEIII

TYPE3

Fitzpatrick Skin Type III

C74572

TYPEIV

TYPE4

Fitzpatrick Skin Type IV

C74573

TYPEV

TYPE5

Individuals who have dark constitutive pigmentation but Fitzpatrick Skin Type V become noticeably darker with sun exposure, especially light complected black individuals, those of Indian descent. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) Individuals who have the heaviest constitutive pigmentation, especially dark skinned black individuals. (Reference: Fitzpatrick TB: The validity and practicality of sun-reactive skin types I through VI. Arch. Dermatol. 1998 124: 869-871) Fitzpatrick Skin Type VI

C74574

TYPEVI

TYPE6

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 443 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C74561 - SKINTYP - Skin Type Codelist extensible: Yes
CDISC Synonym

NCI Code C74592

CDISC Submission Value DRY

CDISC Definition The pores are generally fine with a papery thin texture that feels dry to the touch. Usually flaky and dull looking. The pores are visible but not large. The texture is neither fine or thick and it neither feels dry or oily to the touch. The pores of the skin are generally large and visible with a coarse or thick texture. It has a tendency to look dull and greasy and feels oily to the touch.

NCI Preferred Term Dry Skin

C74593

NORMAL

Normal Skin

C74591

OILY

Oily Skin

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 444 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78733 - SPECCOND - Specimen Condition Codelist extensible: Yes
CDISC Synonym Autolized Specimen Calcified Specimen Clotted Specimen Frozen Specimen Hemolysis in Specimen Icteric Specimen Lipemic Specimen Refrigerated Specimen Ambient Temperature; Specimen at Room Temperature

NCI Code C78725

CDISC Submission Value AUTOLIZED

CDISC Definition A specimen that has undergone autolysis, or self-digestion by the specimen's own digestive enzymes. (NCI) A specimen that has undergone calcification. (NCI) A specimen that has become coagulated. (NCI) A specimen that has been subjected to and immobilized by severe cold. (NCI) A specimen that has undergone the destruction of red blood cells followed by the release of the hemoglobin. (NCI) A specimen that exhibits a yellowish pigmentation due to jaundice. (NCI) A specimen that consists of or contains excessive amounts of fat and fatty substances. (NCI) A specimen that has been kept or preserved at a low temperature in a refrigerator. (NCI) A specimen that has been subjected to and adjusted to the average ambient temperature of a room, usually considered to be around 20 degrees C (68 degrees F). (NCI)

NCI Preferred Term Autolized Specimen

C78723 C78724 C70717 C70720

CALCIFIED CLOTTED FROZEN HEMOLIZED

Calcified Specimen Clotted Specimen Frozen Specimen Hemolysis in Specimen

C98744 C70715 C70718 C70719

ICTERIC LIPEMIC REFRIGERATED ROOM TEMPERATURE

Icteric Specimen Lipemic Specimen Refrigerated Specimen Specimen at Room Temperature

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 445 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78734 - SPECTYPE - Specimen Type Codelist extensible: Yes
CDISC Synonym

NCI Code C12472

CDISC Submission Value ADIPOSE TISSUE

CDISC Definition A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. (NCI)

NCI Preferred Term Adipose Tissue

C13188 C13190 C78729

AMNIOTIC FLUID AQUEOUS HUMOR ARTERIAL BLOOD

Aqua Amnii

The fluid within the amniotic cavity which surrounds and protects the developing embryo. (NCI) The watery fluid which is present in the anterior and posterior chambers of the eye. (NCI) Oxygenated blood which is transported with nutrients to body tissues through the arterial system. The exception is blood within the pulmonary artery which carries deoxygenated blood to the lungs. (NCI) Fatty tissue which is deposited in the inner lining of the arterial wall. (NCI) Fluid composed of waste products, bile acids, salts, cholesterol, and electrolytes. It is secreted by the liver parenchyma and stored in the gallbladder. (NCI) A liquid tissue with the primary function of transporting oxygen and carbon dioxide. It supplies the tissues with nutrients, removes waste products, and contains various components of the immune system defending the body against infection. Calcified connective tissue that forms the skeletal components of the body. (NCI) The tissue occupying the spaces of bone. It consists of blood vessel sinuses and a network of hematopoietic cells which give rise to the red cells, white cells, and megakaryocytes. (NCI) Milk produced by females for the purpose of feeding their young. (NCI) Accumulated material from the secretions of an organ. It is solid and representative examples include gallbladder stones, kidney stones, and salivary gland stones. (NCI)

Amniotic Fluid Aqueous Humor Arterial Blood

C78739 C13192

ATHEROSCLEROTIC PLAQUE BILE

Atherosclerotic Plaque Bile

C12434

BLOOD

Blood

C12366 C12431

BONE BONE MARROW

Bone Bone Marrow

C13257 C35708

BREAST MILK CALCULUS

Breast Milk Stone

C12692

CEREBROSPINAL FLUID

CSF

The fluid that is contained within the brain ventricles, the subarachnoid space and the central canal of the spinal cord. (NCI) A wax secreted by glands in the ear canal. A thick, protein-rich substance secreted by the breasts during the second half of pregnancy and for a few days after birth before the breast milk comes in.

Cerebrospinal Fluid

C32293 C32348

CERUMEN COLOSTRUM

Cerumen Colostrum

C77666 C78741

EMESIS EXPIRED AIR

Emesis; Vomit

Stomach contents that have returned to the mouth or are ejected beyond the mouth. (NCI) The air that moves out of the chest during expiration. It contains a higher percentage of carbon dioxide and a lower percentage of oxygen compared to the inhaled air. (NCI)

Vomitus Expired Air

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 446 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78734 - SPECTYPE - Specimen Type Codelist extensible: Yes
CDISC Synonym

NCI Code C13233

CDISC Submission Value EXUDATE

CDISC Definition Fluid, cells or cellular debris that escapes from the blood vessels and accumulates in nearby tissues. It is the result of inflammation and is rich in proteins. Liquid substances produced by the body. The filamentous outgrowth of the epidermis. (NCI) Vaginal discharge occurring during the post-partum period. It consists of a mixture of blood, mucus, and placental remnants. (NCI)

NCI Preferred Term Exudate

C13236 C32705 C78742

FLUID HAIR LOCHIA

Body Fluid or Substance Hair Lochia

C13273

LUNG SURFACTANT

Surfactant

Pulmonary surfactant lines the lung epithelium and lowers surface tension to prevent collapse at end-expiration. Deficiency of pulmonary surfactant results in respiratory distress syndrome (RDS) in premature infants. Lung surfactant is synthesized in alveolar type II cells, stored in lamellar bodies and secreted via exocytosis. (NCI) A clear, transparent, sometimes faintly yellow and slightly opalescent fluid that is collected from the tissues throughout the body, flows in the lymphatic vessels (through the lymph nodes), and is eventually added to the venous blood circulation. Lymph consists of a clear liquid portion, varying numbers of white blood cells (chiefly lymphocytes), and a few red blood cells. (NCI) The newborn's first intestinal discharge. It is a dark-green, thick substance composed of mucus, intestinal secretions, hair, and intestinal mucosa cells. (NCI) The discharged blood from the uterus during the reproductive years. The discharge occurs approximately once a month. (NCI) The thick fluid secreted by the mucus glands in the aerodigestive tract and the vagina. (NCI) The cutaneous plate on the dorsal surface of the distal end of a finger or toe. (NCI)

Lung Surfactant

C13252

LYMPH

Lymph

C78743

MECONIUM

Meconium

C78740

MENSTRUAL BLOOD

Menstrual Blood

C13259 C33156 C13280 C13356

MUCUS NAIL PERSPIRATION PLASMA Sweat

Mucus Nail Sweat Plasma

The liquid secreted by the sweat glands. (NCI) Plasma is the fluid (acellular) portion of the circulating blood, as distinguished from the serum that is the fluid portion of the blood obtained by removal of the fibrin clot and blood cells after coagulation. The fluid that is abnormally collected in the pleural cavity. (NCI) A slightly alkaline, white fluid secreted from the prostate and is a constituent of semen. A yellowish substance produced during bacterial inflammation. It contains necrotic cells and cells fighting the infection. (NCI) A clear liquid secreted into the mouth by the salivary glands and mucous glands of the mouth; moistens the mouth and starts the digestion of starches. (NCI)

C77613 C100896 C50718

PLEURAL FLUID PROSTATIC FLUID PUS

Pleural Fluid Prostatic Fluid Pus

C13275

SALIVA

Saliva

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 447 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C78734 - SPECTYPE - Specimen Type Codelist extensible: Yes
CDISC Synonym

NCI Code C13276 C13277

CDISC Submission Value SEBUM SEMEN

CDISC Definition A thick, oily substance produced by the sebaceous glands located in the dermis. (NCI) Sebum Semen

NCI Preferred Term

Seminal Plasma

The thick, whitish secretion of the male reproductive organs. It is composed of spermatozoa in their nutrient plasma, secretions from the prostate, seminal vesicles, and various other glands, epithelial cells, and minor constituents. Part of the ejaculated fluid. It contains secretions from the seminal vesicles, Cowper gland, and prostate gland.

C33529 C13325

SEMINAL FLUID SERUM Sera

Seminal Fluid Serum

The clear portion of the blood that remains after the removal of the blood cells and the clotting proteins. (NCI) A white secretion of the sebaceous glands of the foreskin. (NCI) Material containing mucus, cellular debris, microorganisms and sometimes blood or pus. It is ejected through the mouth from the lungs, bronchi, and trachea. (NCI)

C33574 C13278

SMEGMA SPUTUM

Smegma Sputum

C13234

STOOL

Feces

The material discharged from the bowel during defecation. It consists of undigested food, intestinal mucus, epithelial cells, and bacteria. (NCI) A viscid fluid secreted by the synovial membrane, serving as a lubricant. (NCI) An anatomical structure consisting of similarly specialized cells and intercellular matrix, aggregated according to genetically determined spatial relationships, performing a specific function. (NCI) The fluid that passes through the wall of the veins and capillaries to the surrounding tissues because of increased intravascular pressure. It has low protein content. (NCI) The fluid that is excreted by the kidneys. It is stored in the bladder and discharged through the urethra. (NCI) Deoxygenated blood containing urea and other waste products which is transported through the venous system to the heart and lungs. The exception is blood within the pulmonary vein which is oxygenated and travels from the lungs to the left atrium of the heart. (NCI)

Feces

C33718 C12801

SYNOVIAL FLUID TISSUE

Synovial Fluid Tissue

C78744

TRANSUDATE

Transudate

C13283 C78730

URINE VENOUS BLOOD

Urine Venous Blood

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 448 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66728 - STENRF - Relation to Reference Period Codelist extensible: No
CDISC Synonym

NCI Code C38008 C25629 C25456 C25490 C49640 C53279

CDISC Submission Value AFTER BEFORE COINCIDENT DURING DURING/AFTER ONGOING

CDISC Definition The time period following a point or another period of time. (NCI) Earlier in time or order. (NCI) Occurring or operating at the same time. At some point in a given period of time. (NCI) Within a certain period of time or after a certain point or period in time. (NCI) Post Prior

NCI Preferred Term

Concurrent During During Or After Continue

Continuous

Remain in force or carry on without letup; keep or maintain in unaltered condition; exist in time or space without stop or interruption. (NCI) Not known, not observed, not recorded, or refused. (NCI)

C17998

U; Unknown

Unknown

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 449 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C99077 - STYPE - Study Type Codelist extensible: No
CDISC Synonym

NCI Code C98722

CDISC Submission Value EXPANDED ACCESS

CDISC Definition Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access. Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed. Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

NCI Preferred Term Expanded Access Study

C98388

INTERVENTIONAL

Interventional Study

C16084

OBSERVATIONAL

Observational Study

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 450 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66735 - TBLIND - Trial Blinding Schema Codelist extensible: Yes
CDISC Synonym

NCI Code C15228

CDISC Submission Value DOUBLE BLIND

CDISC Definition A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving. (CDISC glossary) A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. (CDISC glossary) A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called singlemasked study. (CDISC glossary)

NCI Preferred Term Double Blind Study

C49659

OPEN LABEL

Open Label Study

C28233

SINGLE BLIND

Single Blind Study

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 451 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66785 - TCNTRL - Control Type Codelist extensible: Yes
CDISC Synonym

NCI Code C49649

CDISC Submission Value ACTIVE

CDISC Definition A type of control, which has a demonstrated effect, administered as a comparator, to subjects in a clinical trial. [From ICH E10]. No person or thing, nobody, not any. (NCI) Use of an inactive compound identical in appearance to drug or treatment being tested in experimental research, which may or may not be known to the physician and/or subject, administered to distinguish between drug action and suggestive effect of the drug or treatment under study. The effects of the active drug or treatment are compared to the effects of the placebo. (NCI)

NCI Preferred Term Active Control

C41132 C49648

NONE PLACEBO

None Placebo Control

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 452 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66787 - TDIGRP - Diagnosis Group Codelist extensible: Yes
CDISC Synonym

NCI Code C49651

CDISC Submission Value HEALTHY SUBJECTS

CDISC Definition An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI)

NCI Preferred Term Healthy Subject

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 453 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C101867 - TIMIFLOW - TIMI Flow Responses Codelist extensible: No
CDISC Synonym Thrombolysis in Myocardial Infarction Flow - 0 Thrombolysis in Myocardial Infarction Flow - 1 Thrombolysis in Myocardial Infarction Flow - 2

NCI Code C100040

CDISC Submission Value TIMI-0

CDISC Definition No perfusion: No antegrade flow beyond the point of occlusion. (www.TIMI.org accessed 21SEP2011)

NCI Preferred Term Thrombolysis in Myocardial Infarction Flow - 0

C100041

TIMI-1

Penetration without perfusion: The contrast material passes beyond the area of obstruction, but fails to opacify the entire coronary bed distal to the obstruction for the duration of the cine run. (www.TIMI.org accessed 21SEP2011) Partial reperfusion: The contrast material passes across the obstruction and opacifies the entire coronary bed distal to the obstruction. However, the rate of entry of contrast into the vessel distal to the obstruction and/or its rate of clearance from the distal bed are perceptibly slower than its entry into and/or clearance from comparable areas not perfused by the culprit vessel (e.g., the opposite coronary artery or coronary bed proximal to the obstruction).(www.TIMI.org accessed 21SEP2011) Complete perfusion: Antegrade flow into the bed distal to the obstruction occurs as promptly as into the bed proximal to the obstruction and clearance of contrast material from the involved bed is as rapid as from an uninvolved bed in the same vessel or the opposite artery. (www.TIMI.org accessed 21SEP2011 )

Thrombolysis in Myocardial Infarction Flow - 1

C100042

TIMI-2

Thrombolysis in Myocardial Infarction Flow - 2

C100043

TIMI-3

Thrombolysis in Myocardial Infarction Flow - 3

Thrombolysis in Myocardial Infarction Flow - 3

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 454 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66736 - TINDTP - Trial Indication Type Codelist extensible: Yes
CDISC Synonym

NCI Code C49654

CDISC Submission Value CURE

CDISC Definition A type of study protocol designed to evaluate intervention(s) aimed to cure a disease or condition. (NCI) A type of study protocol designed to evaluate intervention(s) aimed at identifying a disease or condition. (NCI) A type of study designed to identify actions necessary to eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI) A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen. A type of study protocol designed to evaluate intervention(s) for treatment of disease, syndrome or condition.

NCI Preferred Term Cure Study

C49653

DIAGNOSIS

Diagnosis Study

C49655

MITIGATION

Adverse Effect Mitigation Study

C49657

PREVENTION

Prevention Study

C49656

TREATMENT

Treatment Study

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 455 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66784 - TOXGR - Common Terminology Criteria for Adverse Events Codelist extensible: No
CDISC Synonym Grade 1; 1

NCI Code C41338 1

CDISC Submission Value

CDISC Definition A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. An adverse event, and/or its immediate sequelae, which is associated with an imminent risk of death or which is associated with physical or mental disabilities that affect or limit the ability of a person to perform activities of daily living (eating, ambulation, toileting, etc.) See NCI Common Terminology Criteria for Adverse Events. The termination of life as a result of an adverse event. (NCI)

NCI Preferred Term Mild Adverse Event

C41339

Grade 2; 2

Moderate Adverse Event

C41340

Grade 3; 3

Severe Adverse Event

C41337

Grade 4; 4; LIFE THREATENING

Life Threatening or Disabling Adverse Event

C48275

Grade 5; 5; FATAL

Death Related to Adverse Event

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 456 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C87162 - TOXGR - Common Terminology Criteria for Adverse Events V4.0 Codelist extensible: No
CDISC Synonym ABSENT; Grade 0; 0 MILD; Grade 1; 1

NCI Code C75533 C84263 0 1

CDISC Submission Value

CDISC Definition Grade 0 is universally defined as absence of Adverse Events or within normal limits or values. An adverse event that is asymptomatic; or involves mild or minor symptoms; or is of marginal clinical relevance; or consists of clinical or diagnostic observations alone; or for which intervention is not indicated; or for which only non-prescription intervention is indicated. An adverse event for which only minimal, local, or noninvasive intervention (e.g. packing, cautery) is indicated; or that limits instrumental activities of daily living (ADLs, e.g., shopping, laundry, transportation, or ability to conduct finances). An adverse event that is medically significant but not life-threatening; or for which inpatient care or prolongation of hospitalization are indicated; or that is an important medical event that does not result in hospitalization, but may jeopardize the patient or may require intervention either to prevent hospitalization, to prevent the AE from becoming life-threatening or causing death; or that is disabling; or that results in persistent or significant disability, incapacity, or limitation of self care activities of daily living (ADLs, e.g., getting in and out of bed, dressing, eating, getting around inside, bathing, or using the toilet).

NCI Preferred Term Absent Adverse Event Mild Adverse Event

C84264

MODERATE; Grade 2; 2

Moderate Adverse Event

C84265

SEVERE; Grade 3; 3

Severe Adverse Event

C84266

LIFE An adverse event that has life-threatening THREATENING; consequences; for which urgent intervention is Grade 4; 4 indicated; that puts the patient at risk of death at the time of the event if immediate intervention is not undertaken; or that causes blindness or deafness. FATAL; Grade 5; The termination of life as a result of an adverse event. 5 (NCI)

Life Threatening Adverse Event

C48275

Death Related to Adverse Event

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 457 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66737 - TPHASE - Trial Phase Codelist extensible: Yes
CDISC Synonym NA Trial Phase 1; 1

NCI Code C48660 C15600

CDISC Submission Value NA Phase I Trial

CDISC Definition Determination of a value is not relevant in the current context. (NCI) The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary) A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II. Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary) A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary) A classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial.

NCI Preferred Term Not Applicable Phase I Trial

C15693

Phase I/II Trial

Trial Phase 1-2; 1-2 Trial Phase 2; 2

Phase I/II Trial

C15601

Phase II Trial

Phase II Trial

C15694

Phase II/III Trial

Trial Phase 2-3; 2-3 Trial Phase 3; 3

Phase II/III Trial

C15602

Phase III Trial

Phase III Trial

C49687

Phase IIIa Trial

Trial Phase 3A; 3A

Phase IIIa Trial

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 458 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66737 - TPHASE - Trial Phase Codelist extensible: Yes
CDISC Synonym Trial Phase 3B; 3B

NCI Code C49689

CDISC Submission Value Phase IIIb Trial

CDISC Definition A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval. A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI) A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI) Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Postmarketing surveillance is sometimes referred to as Phase V.

NCI Preferred Term Phase IIIb Trial

C49686

Phase IIa Trial

Trial Phase 2A; 2A Trial Phase 2B; 2B

Phase IIa Trial

C49688

Phase IIb Trial

Phase IIb Trial

C15603

Phase IV Trial

Trial Phase 4; 4

Phase IV Trial

C47865

Phase V Trial

Trial Phase 5; 5

Phase V Trial

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 459 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96778 - TRTEST - Oncology Tumor Properties Test Name Codelist extensible: Yes
CDISC Synonym Area Average Metabolic Standard Uptake Value Diameter

NCI Code C25244 C96566

CDISC Submission Value Area Average Metabolic Standard Uptake Value

CDISC Definition The extent of a 2-dimensional surface enclosed within a boundary. (NCI) A semiquantitative analysis of the average uptake of analyte by body tissue in relation to the total administered dose of the analyte. The length of a straight line passing through the center of a circle or sphere and connecting two points on the circumference. (NCI) The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The longest possible straight line or plane through a body or figure that is at a right angle to a given line or plane. The value of the current measurement divided by the initial value, taken at some baseline event or timepoint, multiplied by 100. The value of the current measurement divided by the lowest value previously recorded multiplied by 100. The transparency of a material to the passage of X-rays and other forms of radiation. The plane through a body or figure that is at the shortest width of that body or figure. A calculation of the aggregated area values. A calculation of the aggregated diameter values. A calculation of the aggregated longest diameter values. A calculation of the aggregated longest perpendicular values. A calculation of the aggregated diameter values taken from the viable portion of the tumor mass. A calculation of the aggregated volume values. A condition or state of a tumor at a particular time. The diameter of the portion of the tumor mass that is capable of growth, proliferation and metastasis. The amount of three dimensional space occupied by an object or the capacity of a space or container. (NCI) Area

NCI Preferred Term

Average Metabolic Standard Uptake Value

C25285

Diameter

Diameter

C96684

Longest Diameter

Longest Diameter Longest Perpendicular Percent Change From Baseline Percent Change From Nadir Radiodensity Short Axis Sum of Area Sum of Diameter Sum of Longest Diameter Sum of Longest Perpendicular Sum of Viable Diameter Sum of Volume Tumor State Viable Diameter Volume

Longest Diameter

C96685

Longest Perpendicular

Longest Perpendicular

C96621

Percent Change From Baseline Percent Change From Nadir Radiodensity Short Axis Sum of Area Sum of Diameter Sum of Longest Diameter Sum of Longest Perpendicular Sum of Viable Diameter Sum of Volume Tumor State Viable Diameter Volume

Percent Change From Baseline

C96622 C96627 C94982 C96630 C96631 C96632 C96633 C96634 C96635 C96643 C96646 C25335

Percent Change From Nadir Radiodensity Short Axis Sum of Areas Sum of Diameters Sum of Longest Diameters Sum of Longest Perpendiculars Sum of Viable Diameters Sum of Volumes Tumor Status Viable Tumor Diameter Volume

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 460 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96779 - TRTESTCD - Oncology Tumor Properties Test Code Codelist extensible: Yes
CDISC Synonym Area Average Metabolic Standard Uptake Value Diameter

NCI Code C25244 C96566

CDISC Submission Value AREA AVMETSUV

CDISC Definition The extent of a 2-dimensional surface enclosed within a boundary. (NCI) A semiquantitative analysis of the average uptake of analyte by body tissue in relation to the total administered dose of the analyte. The length of a straight line passing through the center of a circle or sphere and connecting two points on the circumference. (NCI) The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference. The longest possible straight line or plane through a body or figure that is at a right angle to a given line or plane. The value of the current measurement divided by the initial value, taken at some baseline event or timepoint, multiplied by 100. The value of the current measurement divided by the lowest value previously recorded multiplied by 100. The transparency of a material to the passage of X-rays and other forms of radiation. The plane through a body or figure that is at the shortest width of that body or figure. A calculation of the aggregated area values. A calculation of the aggregated diameter values. A calculation of the aggregated longest diameter values. A calculation of the aggregated longest perpendicular values. A calculation of the aggregated diameter values taken from the viable portion of the tumor mass. A calculation of the aggregated volume values. A condition or state of a tumor at a particular time. The diameter of the portion of the tumor mass that is capable of growth, proliferation and metastasis. The amount of three dimensional space occupied by an object or the capacity of a space or container. (NCI) Area

NCI Preferred Term

Average Metabolic Standard Uptake Value

C25285

DIAMETER

Diameter

C96684

LDIAM

Longest Diameter Longest Perpendicular Percent Change From Baseline Percent Change From Nadir Radiodensity Short Axis Sum of Area Sum of Diameter Sum of Longest Diameter Sum of Longest Perpendicular Sum of Viable Diameter Sum of Volume Tumor State Viable Diameter Volume

Longest Diameter

C96685

LPERP

Longest Perpendicular

C96621

PCHGBL

Percent Change From Baseline

C96622 C96627 C94982 C96630 C96631 C96632 C96633 C96634 C96635 C96643 C96646 C25335

PCHGNAD RADIODEN SAXIS SUMAREA SUMDIAM SUMLDIAM SUMLPERP SUMVDIAM SUMVOL TUMSTATE VDIAM VOLUME

Percent Change From Nadir Radiodensity Short Axis Sum of Areas Sum of Diameters Sum of Longest Diameters Sum of Longest Perpendiculars Sum of Viable Diameters Sum of Volumes Tumor Status Viable Tumor Diameter Volume

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 461 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67152 - TSPARM - Trial Summary Parameter Test Name Codelist extensible: Yes
CDISC Synonym Actual Number of Subjects Adaptive Design

NCI Code C98703 C98704

CDISC Submission Value Actual Number of Subjects Adaptive Design

CDISC Definition Actual number of subjects enrolled; may include subjects who were not randomized. Indicate if the study includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Subgroups of populations based on age. (NCI) An entity that is responsible for the initiation, management, and/or financing of a clinical study.

NCI Preferred Term Actual Subject Number Adaptive Design

C49703

Added on to Existing Treatments Age Span Clinical Study Sponsor

Added on to Existing Treatments Age Span Clinical Study Sponsor; Study Sponsor; Sponsor Comparative Treatment Name Confirmed Response Minimum Duration Control Type

Test Product Added to Existing Treatment Age Group Clinical Study Sponsor

C20587 C70793

C68612

Comparative Treatment Name

A therapeutically active agent that is intended to provide reference measurements for the experimental protocol of a clinical trial. The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment. Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). The literal identifier of the therapy or medication that is currently being given per protocol. This does not include treatment that has been given in the past. A date which indicates any data collected by this date will be used for analysis. Text that describes the cutoff date. A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) The unit of measure for the dosage form. The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) The number of doses administered per a specific interval. Exploratory measures that will be used to evaluate the intervention(s) or, for observational studies, that are exploratory of the study.

Active Comparator Drug

C98715

Confirmed Response Minimum Duration

Confirmed Response Minimum Duration

C49647

Control Type

Control Type

C85582

Current Therapy or Treatment

Current Therapy or Treatment Data Cutoff Date Data Cutoff Description Diagnosis Group

Current Therapy

C98717 C98718 C49650

Data Cutoff Date Data Cutoff Description Diagnosis Group

Data Cutoff Date Data Cutoff Date Description Diagnosis Group

C73558 C25488

Dose Units Dose per Administration

Dose Units Dose per Administration Dosing Frequency Exploratory Outcome Measure

Dosage Form Unit Dose

C89081 C98724

Dosing Frequency Exploratory Outcome Measure

Dose Frequency Exploratory Outcome Measure

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 462 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67152 - TSPARM - Trial Summary Parameter Test Name Codelist extensible: Yes
CDISC Synonym Healthy Subject Indicator

NCI Code C98737

CDISC Submission Value Healthy Subject Indicator

CDISC Definition Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. The trial design developed to compare treatment groups.

NCI Preferred Term Healthy Subject Indicator

C98746 C98747 C41161

Intervention Model Intervention Type Investigational Therapy or Treatment Pharmacological Class of Investigational Therapy

Intervention Model

Intervention Model Intervention Type Protocol Agent

Intervention Type The kind of product or procedure studied in a trial. Investigational Therapy or Treatment Pharmacological Class of Investigational Therapy Planned Country of Investigational Site(s) The investigational product under study.

C98768

The pharmacological class of the investigational product.

Pharmacological Class of Investigational Therapy

C98770

Planned Country of Investigational Site(s) Planned Maximum Age of Subjects Planned Minimum Age of Subjects Planned Number of Arms Planned Number of Subjects

The country name of planned study facility which has received IRB approval.

Planned Country of Investigational Site Planned Maximum Age of Subjects

C49694

Planned The anticipated maximum age of the subjects to be Maximum Age of entered in a clinical trial. (NCI) Subjects Planned Minimum Age of Subjects Planned Number of Arms Planned Number of Subjects; Planned Enrollment; Target Enrollment; Anticipated Enrollment Primary Outcome Measure The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) The planned number of intervention groups. The planned number of subjects to be entered in a clinical trial. (NCI)

C49693

Planned Minimum Age of Subjects

C98771 C49692

Planned Number of Arms Planned Subject Number

C98772

Primary Outcome Measure

The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s). The randomization quotient is the number of planned subjects to be exposed to investigational therapy, independent of dose or other factors, divided by the total number of planned subjects. Identification numbers assigned to the protocol by ct.gov, EudraCT, or other registries. The course by which a substance was administered in order to reach the site of action in the body.

Primary Outcome Measure

C98775

Randomization Quotient

Randomization Quotient

Randomization Quotient

C98714 C38114

Registry Identifier Route of Administration

Registry Identifier Route of Administration

Clinical Trial Registry Identifier Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 463 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67152 - TSPARM - Trial Summary Parameter Test Name Codelist extensible: Yes
CDISC Synonym Secondary Outcome Measure Sex of Participants Stable Disease Minimum Duration Study End Date

NCI Code C98781

CDISC Submission Value Secondary Outcome Measure

CDISC Definition Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s). The specific sex, either male, female, or mixed of the subject group being studied. (NCI) The protocol specified minimum amount of time needed to meet the definition of stable disease. Final date on which data was collected for any subject (Date/Time of End of Participation, RFPENDTC) based on the protocol. The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included. The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Describes the role the study plays in determining the interventions a subject receives. The name of a code list that contains terms to define the type of blinding for the trial. (NCI) The basis for initiation of a treatment for a disease or of a diagnostic test (causal, or symptomatic, or disease-specific indication). The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) Planned length of observation for a single subject. Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI) The principal purpose of the trial. The auxiliary purpose of the trial. The name of a clinical trial. (NCI)

NCI Preferred Term Secondary Outcome Measure

C49696 C98783

Sex of Participants Stable Disease Minimum Duration Study End Date

Sex of Study Group Stable Disease Minimum Duration

C90462

Study End Date

C69208

Study Start Date

Study Start Date

Study Date

C49698

Study Stop Rules

Study Stop Rules

Study Stop Rules

C15320 C49658 C41184

Study Type Trial Blinding Schema Trial Indication

Study Type Trial Blinding Schema Trial Indication

Study Design Trial Blinding Schema Indication

C49652 C49697 C48281

Trial Indication Type Trial Length Trial Phase Classification

Trial Indication Type Trial Length Trial Phase Classification

Trial Indication Type Trial Length Trial Phase

C85826 C85827 C49802

Trial Primary Objective Trial Secondary Objective Trial Title

Trial Primary Objective Trial Secondary Objective Trial Title

Trial Primary Objective Trial Secondary Objective Trial Title

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 464 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67152 - TSPARM - Trial Summary Parameter Test Name Codelist extensible: Yes
CDISC Synonym Trial Type Trial is Randomized

NCI Code C49660 C25196

CDISC Submission Value Trial Type Trial is Randomized

CDISC Definition The type of clinical trial performed e.g. efficacy, safety. (NCI) The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary)

NCI Preferred Term Trial Type Randomization

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 465 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66738 - TSPARMCD - Trial Summary Parameter Test Code Codelist extensible: Yes
CDISC Synonym Actual Number of Subjects Adaptive Design

NCI Code C98703 C98704

CDISC Submission Value ACTSUB ADAPT

CDISC Definition Actual number of subjects enrolled; may include subjects who were not randomized. Indicate if the study includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products.

NCI Preferred Term Actual Subject Number Adaptive Design

C49703

ADDON

Added on to Existing Treatments

Test Product Added to Existing Treatment Planned Maximum Age of Subjects

C49694

AGEMAX

Planned The anticipated maximum age of the subjects to be Maximum Age of entered in a clinical trial. (NCI) Subjects Planned Minimum Age of Subjects Age Span Comparative Treatment Name Confirmed Response Minimum Duration Current Therapy or Treatment Data Cutoff Description Data Cutoff Date Dose per Administration Dosing Frequency Dose Units Planned Country of Investigational Site(s) Healthy Subject Indicator The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) Subgroups of populations based on age. (NCI) A therapeutically active agent that is intended to provide reference measurements for the experimental protocol of a clinical trial. The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment. The literal identifier of the therapy or medication that is currently being given per protocol. Text that describes the cutoff date. A date which indicates any data collected by this date will be used for analysis. The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) The number of doses administered per a specific interval. The unit of measure for the dosage form. The country name of planned study facility which has received IRB approval. Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. The basis for initiation of a treatment for a disease or of a diagnostic test (causal, or symptomatic, or disease-specific indication). The trial design developed to compare treatment groups.

C49693

AGEMIN

Planned Minimum Age of Subjects

C20587 C68612

AGESPAN COMPTRT

Age Group Active Comparator Drug

C98715

CRMDUR

Confirmed Response Minimum Duration

C85582 C98718 C98717 C25488

CURTRT DCUTDESC DCUTDTC DOSE

Current Therapy Data Cutoff Date Description Data Cutoff Date Dose

C89081 C73558 C98770

DOSFRQ DOSU FCNTRY

Dose Frequency Dosage Form Unit Planned Country of Investigational Site Healthy Subject Indicator

C98737

HLTSUBJI

C41184

INDIC

Trial Indication

Indication

C98746

INTMODEL

Intervention Model

Intervention Model

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 466 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66738 - TSPARMCD - Trial Summary Parameter Test Code Codelist extensible: Yes
CDISC Synonym

NCI Code C98747 C49697 C98771 C85826 C85827 C98724

CDISC Submission Value INTTYPE LENGTH NARMS OBJPRIM OBJSEC OUTMSEXP

CDISC Definition

NCI Preferred Term Intervention Type Trial Length Planned Number of Arms Trial Primary Objective Trial Secondary Objective Exploratory Outcome Measure

Intervention Type The kind of product or procedure studied in a trial. Trial Length Planned Number of Arms Trial Primary Objective Trial Secondary Objective Exploratory Outcome Measure Primary Outcome Measure Planned length of observation for a single subject. The planned number of intervention groups. The principal purpose of the trial. The auxiliary purpose of the trial. Exploratory measures that will be used to evaluate the intervention(s) or, for observational studies, that are exploratory of the study. The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s). Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s). The pharmacological class of the investigational product.

C98772

OUTMSPRI

Primary Outcome Measure

C98781

OUTMSSEC

Secondary Outcome Measure Pharmacological Class of Investigational Therapy Planned Number of Subjects; Planned Enrollment; Target Enrollment; Anticipated Enrollment Trial is Randomized

Secondary Outcome Measure

C98768

PCLAS

Pharmacological Class of Investigational Therapy

C49692

PLANSUB

The planned number of subjects to be entered in a clinical trial. (NCI)

Planned Subject Number

C25196

RANDOM

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) The randomization quotient is the number of planned subjects to be exposed to investigational therapy, independent of dose or other factors, divided by the total number of planned subjects. Identification numbers assigned to the protocol by ct.gov, EudraCT, or other registries. The course by which a substance was administered in order to reach the site of action in the body.

Randomization

C98775

RANDQT

Randomization Quotient

Randomization Quotient

C98714 C38114

REGID ROUTE

Registry Identifier Route of Administration

Clinical Trial Registry Identifier Route of Administration

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 467 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66738 - TSPARMCD - Trial Summary Parameter Test Code Codelist extensible: Yes
CDISC Synonym Stable Disease Minimum Duration Study End Date

NCI Code C98783

CDISC Submission Value SDMDUR

CDISC Definition The protocol specified minimum amount of time needed to meet the definition of stable disease. Final date on which data was collected for any subject (Date/Time of End of Participation, RFPENDTC) based on the protocol. The specific sex, either male, female, or mixed of the subject group being studied. (NCI) An entity that is responsible for the initiation, management, and/or financing of a clinical study.

NCI Preferred Term Stable Disease Minimum Duration

C90462

SENDTC

Study End Date

C49696 C70793

SEXPOP SPONSOR

Sex of Participants Clinical Study Sponsor; Study Sponsor; Sponsor Study Start Date

Sex of Study Group Clinical Study Sponsor

C69208

SSTDTC

The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included. The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Describes the role the study plays in determining the interventions a subject receives. The name of a code list that contains terms to define the type of blinding for the trial. (NCI) Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) The name of a clinical trial. (NCI) Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI)

Study Date

C49698

STOPRULE

Study Stop Rules

Study Stop Rules

C15320 C49658 C49647

STYPE TBLIND TCNTRL

Study Type Trial Blinding Schema Control Type

Study Design Trial Blinding Schema Control Type

C49650

TDIGRP

Diagnosis Group

Diagnosis Group

C49652 C49802 C48281

TINDTP TITLE TPHASE

Trial Indication Type Trial Title Trial Phase Classification

Trial Indication Type Trial Title Trial Phase

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 468 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66738 - TSPARMCD - Trial Summary Parameter Test Code Codelist extensible: Yes
CDISC Synonym Investigational Therapy or Treatment Trial Type

NCI Code C41161

CDISC Submission Value TRT

CDISC Definition The investigational product under study.

NCI Preferred Term Protocol Agent

C49660

TTYPE

The type of clinical trial performed e.g. efficacy, safety. (NCI)

Trial Type

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 469 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66739 - TTYPE - Trial Type Codelist extensible: Yes
CDISC Synonym

NCI Code C49664

CDISC Submission Value BIO-AVAILABILITY

CDISC Definition A study of the degree to which or rate at which a drug or other substance is absorbed or becomes available at the site of physiological activity after administration. (NCI) A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI) A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI) Studies that are conducted to assess the effect of food on the rate and extent of absorption of a drug, either compared to a fasted state or to a reference drug. A study of the biochemical and physiological effect of a drug and the mechanism of drug action and the relationship between drug concentration and effect. (NCI) A study that assesses the value associated with a given drug in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indirect, and intangible costs) of drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in therapeutic benefits to the difference in costs between treatment alternatives. (NCI) A study of identification and analysis of genomic variations that affect the efficacy of a drug. Pharmacogenomic studies can potentially be predictive of an individual's drug-response or adverse reactions or susceptibility to iatrogenic disorders, and may also reveal new targets that can help in the design of new drugs. (NCI) A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI) A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests. A type of safety study thatassesses the degree to which overt adverse effects can be toleratedby the subject.

NCI Preferred Term Bioavailability Study

C49665

BIO-EQUIVALENCE

Therapeutic Equivalency Study

C49666

EFFICACY

Efficacy Study

C98729

FOOD EFFECT

Food Effect Study

C49662

PHARMACODYNAMIC

Pharmacodynamic Study

C39493

PHARMACOECONOMIC

Pharmacoeconomic Study

C49661

PHARMACOGENOMIC

Pharmacogenomic Study

C49663

PHARMACOKINETIC

Pharmacokinetic Study

C49667

SAFETY

Safety Study

C98791

TOLERABILITY

Tolerability Study

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 470 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96780 - TUMIDENT - Tumor Identification Results Codelist extensible: Yes
CDISC Synonym

NCI Code C94522 C94521

CDISC Submission Value NEW NON-TARGET

CDISC Definition The identification of a tumor which has not been previously seen or characterized. The identification of a tumor or site of disease that is present at baseline and not considered a target tumor, but may be part of the objective assessment of the response to the therapeutic intervention. The identification of a tumor that is present at baseline, is measurable and is the primary target of the therapeutic intervention.

NCI Preferred Term New Lesion Identification Non-Target Lesion Identification

C94520

TARGET

Target Lesion Identification

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 471 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96783 - TUTEST - Tumor Identification Test Name Codelist extensible: Yes
CDISC Synonym Tumor Identification Tumor Merged Tumor Split

NCI Code C94523 C94525 C96642

CDISC Submission Value Tumor Identification Tumor Merged Tumor Split

CDISC Definition An indication that a tumor has been located and characterized. An indication that multiple tumors have coalesced into one tumor. An indication that a single tumor has divided into two or more tumors.

NCI Preferred Term Tumor Identification Matted Tumor Mass Present Tumor Split

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 472 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C96784 - TUTESTCD - Tumor Identification Test Code Codelist extensible: Yes
CDISC Synonym Tumor Merged Tumor Identification Tumor Split

NCI Code C94525 C94523 C96642

CDISC Submission Value TUMERGE TUMIDENT TUSPLIT

CDISC Definition An indication that multiple tumors have coalesced into one tumor. An indication that a tumor has been located and characterized. An indication that a single tumor has divided into two or more tumors.

NCI Preferred Term Matted Tumor Mass Present Tumor Identification Tumor Split

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 473 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Percentage Percent Volume per Volume

NCI Code C25613 C48571

CDISC Submission Value % %(v/v)

CDISC Definition A fraction or ratio with 100 understood as the denominator. (NCI) A percent ratio of volume to volume, defined by the equation: [volume of solute (in ml)/ volume of solution (in ml)](100), typically used for admixtures of solutions.(NCI) A percent ratio of weight to volume, defined by the equation: [weight of solute (in gm)/volume of solution (in dl)](100). Since the numerator and denominator of this ratio have different units, it is not a true percentage. A 1% w/v solution is defined as being 1 gram of solute dissolved in 100 milliliters of solvent.(NCI) A percent ratio of weight to weight, defined by the equation: [weight of solute (in gm)/weight of solution (in gm)](100).(NCI) A unit of measure equal to the instances of an entity per visual field of a microscope set to its maximum magnification power. A unit of measure equal to the instances of an entity per visual field of a microscope set to its minimum magnification power. A frequency rate of occurrences of something within a period of time equal to twenty-four hours. (NCI) A rate of occurrences of something within a period of time equal to sixty minutes. Every month. (NCI) A volume unit equal to one microliter used as a denominator to build a derived unit expressed as a ratio. (NCI) Every week. (NCI) A unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one hundred international units per one milliliter of system volume.(NCI) A unit of measurement equal to 10 to the twelfth power of the number of entities per unit of volume equal to one liter. A unit of measurement of viable bacterial numbers equal to 10 to the third power colony forming units. A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the third power colony forming units in one gram of substance.

NCI Preferred Term Percentage Percent Volume per Volume

C48527

%(w/v)

Percent Weight per Volume

Percent Mass per Volume

C48528

%(w/w)

Percent Weight per Weight per High Powered Field per Low Powered Field Per Day Per Hour Every Month; Per Month Per Microliter

Percent Mass per Mass

C96619

/HPF

Per High Powered Field

C96620

/LPF

Per Low Powered Field

C66968 C66966 C64498 C67254

/day /h /month /uL

/day /h Monthly /uL

C67069 C71185

/wk 100 IU/mL

Every week; Per Week 100 International units/Milliliter

Weekly 100 International Units per Milliliter

C67308

10^12/L

10^6/uL

Million per Microliter

C68895

10^3 CFU

Thousand Colony Forming Units; Thousand CFU Thousand Colony Forming Units per Gram; Thousand CFU/g

Thousand Colony Forming Units

C68899

10^3 CFU/g

Thousand Colony Forming Units per Gram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 474 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Thousand Colony Forming Units per Milliliter; Thousand CFU/mL

NCI Code C68903

CDISC Submission Value 10^3 CFU/mL

CDISC Definition A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the third power colony forming units in one milliliter of substance. A unit of measurement equal to 10 to the third power of the number of deoxyribonucleic acid (DNA) copies per unit of volume equal to one milliliter. A unit of measurement equal to 10 to the third power of the number of ribonucleic acid (RNA) copies per unit of volume equal to one milliliter. The unit of concentration expressed as the number of 10 to the third power copies in unit volume equal to one milliliter. (NCI)

NCI Preferred Term Thousand Colony Forming Units per Milliliter

C98788

10^3 DNA copies/mL

Thousand DNA Copies per Milliliter

C98790

10^3 RNA copies/mL

Thousand RNA Copies per Milliliter

C100897

10^3 copies/mL

Thousand Copies per Milliliter

C71187 C71190

10^3 organisms 10^3 organisms/g

Thousand Organisms Thousand Organisms per Gram; Thousand Organisms/g Thousand Organisms per Milliliter; Thousand Organisms/mL

A unit of measure of quantity of organisms expressed in 10 to the third power of organisms. A unit of measure of organism content expressed in 10 to the third power of organisms per unit of mass equal to one gram. A unit of measure of organism concentration expressed in 10 to the third power of organisms per unit of volume equal to one milliliter.

Thousand Organisms Thousand Organisms per Gram

C71195

10^3 organisms/mL

Thousand Organisms per Milliliter

C98789

10^3/hpf

A unit of measurement equal to 10 to the third power of the number of entities per unit of area equal to one high powered field. A unit of measurement equal to 10 to the fourth power of the number of entities per unit of area equal to one high powered field. A unit of measurement equal to 10 to the fifth power of the number of entities per unit of area equal to one high powered field. Million Colony Forming Units; Million CFU Million Colony Forming Units per Gram; Million CFU/g Million Colony Forming Units per Milliliter; Million CFU/mL A unit of measurement of viable bacterial numbers equal to 10 to the sixth power colony forming units. A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the sixth power colony forming units in one gram of substance. A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the sixth power colony forming units in one milliliter of substance. A unit of measurement equal to 10 to the sixth power of the number of deoxyribonucleic acid (DNA) copies per unit of volume equal to one milliliter.

Thousand per High Powered Field

C98787

10^4/hpf

Ten Thousand per High Powered Field Hundred Thousand per High Powered Field Million Colony Forming Units

C98743

10^5/hpf

C68896

10^6 CFU

C68900

10^6 CFU/g

Million Colony Forming Units per Gram

C68904

10^6 CFU/mL

Million Colony Forming Units per Milliliter

C98756

10^6 DNA copies/mL

Million DNA Copies per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 475 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Million International Units; Million IU

NCI Code C67335

CDISC Submission Value 10^6 IU

CDISC Definition A unit of biological activity equal to 10 to the sixth power international units. A unit of measurement equal to 10 to the sixth power of the number of international units of an entity per unit of volume equal to one milliliter. A unit of measurement equal to 10 to the sixth power of the number of ribonucleic acid (RNA) copies per unit of volume equal to one milliliter. The unit of concentration expressed as the number of 10 to the sixth power copies in unit volume equal to one milliliter. (NCI)

NCI Preferred Term Million International Units

C98757

10^6 IU/mL

Million International Units per Milliliter Million RNA Copies per Milliliter

C98760

10^6 RNA copies/mL

C100898

10^6 copies/mL

Million Copies per Milliliter

C71188 C71191

10^6 organisms 10^6 organisms/g

Million Organisms Million Organisms per Gram; Million Organisms/g Million Organisms per Milliliter; Million Organisms/mL Million Organisms per Milligram; Million Organisms/mg 10^3/mL

A unit of measure of quantity of organisms expressed in 10 to the sixth power of organisms. A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one gram. A unit of measure of organism concentration expressed in 10 to the sixth power of organisms per unit of volume equal to one milliliter.

Million Organisms Million Organisms per Gram

C71196

10^6 organisms/mL

Million Organisms per Milliliter

C71193

10^6 organisms/mg

A unit of measure of organism content expressed in 10 to the sixth power of organisms per unit of mass equal to one milligram.

Million Organisms per Milligram

C67452

10^6/L

A unit of measurement equal to 10 to the sixth power of the number of entities per unit of volume equal to one liter. A unit of measurement equal to 10 to the sixth power of the number of entities per unit of mass equal to one gram. A unit of measurement equal to 10 to the sixth power of the number of entities per unit of area equal to one high powered field.

Thousand per Milliliter

C98758

10^6/g

Million per Gram

C98759

10^6/hpf

Million per High Powered Field

C98786

10^7/L

10^6/dL

A unit of measurement equal to 10 to the seventh power of the number of entities per unit of volume equal to one liter. A unit of measurement of viable bacterial numbers equal to 10 to the ninth power colony forming units. A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of 10 to the ninth power colony forming units in one gram of substance.

Ten Million per Liter

C68897

10^9 CFU

Billion Colony Forming Units; Billion CFU Billion Colony Forming Units per Gram; Billion CFU/g

Billion Colony Forming Units

C68901

10^9 CFU/g

Billion Colony Forming Units per Gram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 476 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Billion Colony Forming Units per Milliliter; Billion CFU/mL Billion Organisms Billion Organisms per Gram; Billion Organisms/g Billion Organisms per Milliliter; Billion Organisms/mL Billion Organisms per Milligram; Billion Organisms/mg 10^3/uL;10^3/ mm3 Arbitrary Fluorescence Unit Ampule Dosing Unit Application Dosing Unit Absorbance Unit

NCI Code C68905

CDISC Submission Value 10^9 CFU/mL

CDISC Definition A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of 10 to the ninth power colony forming units in one milliliter of substance. A unit of measure of quantity of organisms expressed in 10 to the ninth power of organisms. A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one gram. A unit of measure of organism concentration expressed in 10 to the ninth power of organisms per unit of volume equal to one milliliter.

NCI Preferred Term Billion Colony Forming Units per Milliliter

C71189 C71192

10^9 organisms 10^9 organisms/g

Billion Organisms Billion Organisms per Gram

C71197

10^9 organisms/mL

Billion Organisms per Milliliter

C71194

10^9 organisms/mg

A unit of measure of organism content expressed in 10 to the ninth power of organisms per unit of mass equal to one milligram.

Billion Organisms per Milligram

C67255

10^9/L

A unit of measurement equal to 10 to the ninth power of the number of entities per unit of volume equal to one liter. Arbitrary unit(s) of fluorescent luminescence. (NCI)

Billion per Liter

C77534

AFU

Arbitrary Fluorescence Units

C48473 C102404 C73686

AMPULE APPLICATION AU

A dosing measurement based on the ampule unit.(NCI) A dosing measurement based on the amount of substance applied. A unit of optical density expressed as the absorbance of light transmitted through the medium on the logarithmic scale. (NCI) Unit of measure of potency of allergenic product expressed as a number of allergy units per one milliliter of formulation.(NCI) A unit of a speed of optical density change expressed as a logarithm of absorbance of light transmitted through a partially absorbing substance per minute. (NCI) A measure of an antigen potency defined as a number of antigen units per one milliliter of product.(NCI) A dosing measurement based on the bag unit.(NCI) A dosing measurement based on the bar unit.(NCI) A unit used for standardization of an allergenic product based on evaluation of product potency against reference standard in combined in vivo (skin test) and in vitro (IgE-based ELISA) testing.(NCI)

Ampule Dosing Unit Application Dosing Unit AU

C70504

AU/mL

Allergy Unit per Milliliter Absorbance Unit per Minute

Allergy Unit per Milliliter

C73687

AU/min

AU/min

C70500 C48474 C48475 C70505

AgU/mL BAG BAR BAU

Antigen Unit per Milliliter Bag Dosing Unit Bar Dosing Unit Bioequivalent Allergy Unit

Antigen Unit per Milliliter Bag Dosing Unit Bar Dosing Unit Bioequivalent Allergy Unit

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 477 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Beats per Minute Bolus Dosing Unit Bottle Dosing Unit Box Dosing Unit Breaths per Minute Becquerel

NCI Code C49673 C48476 C48477 C48478 C49674 C42562

CDISC Submission Value BEATS/MIN BOLUS BOTTLE BOX BREATHS/MIN Bq

CDISC Definition The number of heartbeats measured per minute time. (NCI) A dosing measurement based on the bolus unit.(NCI) A dosing measurement based on the bottle unit.(NCI) A dosing measurement based on the box unit.(NCI) The number of breaths (inhalation and exhalation) taken per minute time. (NCI) A unit of activity of a radionuclide, equal to one nuclear disintegration or other nuclear transition from a particular energy state occurring in an amount of a radionuclide during one second-long time interval.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Becquerel per unit volume equal to one liter.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one Becquerel of the sample with total mass of one gram.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one Becquerel of the sample with total mass of one kilogram.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Becquerel per unit volume equal to one milliliter or one kilobecquerel per liter.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one Becquerel of the sample with total mass of one milligram.(NCI)

NCI Preferred Term Beats per Minute Bolus Dosing Unit Bottle Dosing Unit Box Dosing Unit Breaths per Minute Becquerel

C71165

Bq/L

Becquerel per Liter

Becquerel per Liter

C70522

Bq/g

Becquerel per Gram Becquerel per Kilogram Becquerel per Milliliter; kBq/L; Kilobecquerel per Liter Becquerel per Milligram; kBq/g; Kilobecquerel per Gram Becquerel per Microliter; kBq/mL; Kilobecquerel per Milliliter; MBq/L; Megabecquerel per Liter Becquerel per Microgram; kBq/mg; Kilobecquerel per Milligram; MBq/g; Megabecquerel per Gram; Bq/mcg

Becquerel per Gram

C70521

Bq/kg

Becquerel per Kilogram

C71167

Bq/mL

Becquerel per Milliliter

C70524

Bq/mg

Becquerel per Milligram

C71166

Bq/uL

A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Becquerel per unit volume equal to one millionth of a liter.(NCI)

Becquerel per Microliter

C70523

Bq/ug

A unit of specific radioactivity (massic activity) equal to activity of one Becquerel of the sample with total mass of one microgram.(NCI)

Becquerel per Microgram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 478 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Degree Celsius

NCI Code C42559

CDISC Submission Value C

CDISC Definition A unit of temperature, named after the Swedish astronomer Anders Celsius, who first proposed the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin.(NCI) A dosing measurement based on the can unit.(NCI) A unit of measure equal to the amount that the cap on the bottle can contain. A dosing measurement based on the capsule unit.(NCI) A dosing measurement based on the cartridge unit.(NCI) A potency unit defined as a minimal dose of infectious material at which preparation causes cytopathic effects (changes in the morphology and metabolism of cell culture cells, indicating cell death, due to suspected infection) in the 50% of the cell culture-containing vessels inoculated with that dilution of infectious material.(NCI) A potency unit equal to the potency at which one dose of preparation contains one 50 percent cell culture infective dose.(NCI) A unit of measurement of viable bacterial organisms in a unit mass of substance of interest defined as the number of colony forming units in one gram of substance.(NCI) A unit of measurement of viable bacterial organisms in a unit volume of substance of interest defined as the number of colony forming units in one milliliter of substance.(NCI) A dosing measurement based on the coat unit.(NCI) A dosing measurement based on the container unit.(NCI) A dosing measurement based on the cup unit.(NCI) A dosing measurement based on the cylinder unit.(NCI) A unit of radioactivity defined as 3.7 E10 atomic disintegrations or other nuclear transformations per second. One Curie is equal to 37 gigabecquerels.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one liter.(NCI)

NCI Preferred Term Degree Celsius

C48479 C102405 C48480 C48481 C70534

CAN CAPFUL CAPSULE CARTRIDGE CCID 50

Can Dosing Unit Capful Dosing Unit Capsule Dosing Unit; cap Cartridge Dosing Unit 50 Percent Cell Culture Infective Dose

Can Dosing Unit Capful Dosing Unit Capsule Dosing Unit Cartridge Dosing Unit 50 Percent Cell Culture Infective Dose

C70535

CCID 50/dose

50 Percent Cell Culture Infective Dose per Dose Colony Forming Unit per Gram

50 Percent Cell Culture Infective Dose per Dose Colony Forming Unit per Gram

C68898

CFU/g

C68902

CFU/mL

Colony Forming Unit per Milliliter Coat Dosing Unit Container Dosing Unit Cup Dosing Unit Cylinder Dosing Unit Curie

Colony Forming Unit per Milliliter

C48483 C48484 C54703 C48489 C48466

COAT CONTAINER CUP CYLINDER Ci

Coat Dosing Unit Container Dosing Unit Cup Dosing Unit Cylinder Dosing Unit Curie

C71170

Ci/L

Curie per Liter; uCi/uL; Microcurie per Microliter

Curie per Liter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 479 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Curie per Gram; uCi/ug; Microcurie per Microgram; mCi/mg; Millicurie per Milligram Curie per Kilogram; uCi/mg; Microcurie per Milligram; mCi/g; Millicurie per Gram Curie per Milliliter

NCI Code C70528

CDISC Submission Value Ci/g

CDISC Definition A unit of specific radioactivity (massic activity) equal to activity of one Curie of the sample with total mass of one gram.(NCI)

NCI Preferred Term Curie per Gram

C70529

Ci/kg

A unit of specific radioactivity (massic activity) equal to activity of one Curie of the sample with total mass of one kilogram.(NCI)

Curie per Kilogram

C71172

Ci/mL

A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one milliliter.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one Curie of the sample with total mass of one milligram.(NCI)

Curie per Milliliter

C70531

Ci/mg

Curie per Milligram; mCi/ug; Millicurie per Microgram Curie per Microliter; Ci/mcL Curie per Microgram; Ci/mcg Coulomb

Curie per Milligram

C71171

Ci/uL

A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one Curie per unit volume equal to one millionth of a liter.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one Curie of the sample with total mass of one microgram.(NCI) A unit of quantity of electricity, equal to the quantity of charge transferred in one second across a conductor in which there is a constant current of one Ampere.(NCI) The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours. This also refers to a specific day. (NCI) A unit of potency of poliovirus vaccine used for poliomyelitis prevention. The unit is poliovirus type-specific.(NCI) A unit of potency of poliovirus vaccine expressed as a number of D antigen units per one milliliter of vaccine formulation.(NCI) A unit of measurement of the optical power of a curved mirror or lens represented by the inverse of the focal length in meters. A dosing measurement based on the disk unit.(NCI) The unit of concentration of deoxyribonucleic acid (DNA) copies expressed as a number of copies in unit volume equal to one milliliter.

Curie per Microliter

C70530

Ci/ug

Curie per Microgram

C42550

Coulomb

Coulomb

C25301

DAYS

Day

Day

C70501

DAgU

D Antigen Unit

D Antigen Unit

C70502

DAgU/mL

D Antigen Unit per Milliliter Diopter

D Antigen Unit per Milliliter

C100899

DIOPTER

Diopter

C48490 C98719

DISK DNA copies/mL

Disk Dosing Unit DNA Copies per Milliliter

Disk Dosing Unit DNA Copies per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 480 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Drum Dosing Unit 50 Percent Embryo Infective Dose 50 Percent Embryo Infective Dose per Dose

NCI Code C48492 C70532

CDISC Submission Value DRUM EID 50

CDISC Definition A dosing measurement based on the drum unit.(NCI) Amount of infectious agent or biological product that causes infection in the 50% of embryos such as chicken embryos used in the product potency assay or pathogen activity assay.(NCI) A potency unit for measuring infectious activity of a biologic product or an infectious agent preparation equal to the potency at which one dose of infectious material contains one 50 percent embryo infective dose.(NCI) A unit for measuring concentration or/and reactivity of a test substance (an antigen or antibody of interest) as defined in the literature reference standard for the particular quantitative enzyme-linked immunosorbent assay method. The enzyme-linked immunosorbent assay unit is used to express potency of immunologically active substances and products, e.g. vaccines.(NCI) A unit for measuring potency of immunologically active substance in a product determined as reactivity in a quantitative immunoassay for particular antigen or antibody and expressed per quantity of preparation used as a single dose.(NCI) A unit for measuring potency of immunologically active substance in a product determined as reactivity in a quantitative immunoassay for particular antigen or antibody and expressed per unit volume equal to one milliliter.(NCI) A unit of measure equal to one milligram of urobilinogen per deciliter. The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a Kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI) A unit of measure for the concentration of fibrin degradation products in a sample, calculated based upon the mass of fibrinogen contained within that sample.

NCI Preferred Term Drum Dosing Unit 50 Percent Embryo Infective Dose

C70533

EID 50/dose

50 Percent Embryo Infective Dose per Dose

C68875

ELISA unit

Enzyme-Linked Immunosorbent Assay Unit

Enzyme-Linked Immunosorbent Assay Unit

C68876

ELISA unit/dose

Enzyme-Linked Immunosorbent Assay Unit per Dose Enzyme-Linked Immunosorbent Assay Unit per Milliliter Ehrlich Units Degree Fahrenheit

Enzyme-Linked Immunosorbent Assay Unit per Dose

C68877

ELISA unit/mL

Enzyme-Linked Immunosorbent Assay Unit per Milliliter

C96599 C44277

EU F

Ehrlich Unit Degree Fahrenheit

C96649

FEU

Fibrinogen Equivalent Units

Fibrinogen Equivalent Unit

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 481 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Fingertip Unit

NCI Code C71321

CDISC Submission Value FINGERTIP UNIT

CDISC Definition An arbitrary dosing unit used predominantly for semisolid topical formulations such as cream, ointment, paste, etc. One fingertip unit is the amount of a product that is squeezed out from a standard tube with 5-millimeter diameter nozzle along an adult's fingertip. A fingertip length is defined from the tip of the index finger to the first finger crease. A fingertip dosing unit varies with age and size of the body. The average fingertip unit is equal to approximately 0.5 gram for an adult male and 0.4 gram for an adult female.(NCI) A unit of capacitance equal to the capacitance of a capacitor having an equal and opposite charge of one coulomb on each plate and a potential difference of one volt between the plates.(NCI) A unit of radioactivity equal to one billion nuclear disintegrations or other nuclear transformations per second, or to 10E9 Becquerels.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one gigabecquerel of the sample with total mass of one gram.(NCI)

NCI Preferred Term Fingertip Dosing Unit

C42552

Farad

Farad

Farad

C70513

GBq

Gigabecquerel

Gigabecquerel

C70525

GBq/g

Gigabecquerel per Gram; kBq/ug; Kilobecquerel per Microgram Gigabecquerel per Milligram; Megabecquerel per Microgram; MBq/mcg; MBq/ug Gigabecquerel per microgram; MBq/ng; Megabecquerel per nanogram; GBq/mcg Gauss

Gigabecquerel per Gram

C70527

GBq/mg

A unit of specific radioactivity (massic activity) equal to activity of one gigabecquerel of the sample with total mass of one milligram.(NCI)

Gigabecquerel per Milligram

C70526

GBq/ug

A unit of specific radioactivity (massic activity) equal to activity of one gigabecquerel of the sample with total mass of one microgram.(NCI)

Gigabecquerel per Microgram

C68915

Gauss

The unit of magnetic flux density. A field of one Gauss exerts a force on a conductor, placed in the field of 0.1 dyne per Ampere of current per centimeter of conductor. One Gauss represents a magnetic flux of one Maxwell per square centimeter of cross-section perpendicular to the field. One Gauss equals 10-4 Tesla.(NCI) A unit of absorbed radiation dose. One gray is equal to an absorbed dose of one joule per kilogram of matter, or to 100 rads.(NCI) A dosing measurement based on the homeopathic dilution unit.(NCI) A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) The area visible under the maximum magnification power of the objective being used in microscopy.(NCI)

Gauss

C18063

Gy

Gray

Gray

C48498 C25529

HOMEOPATHIC DILUTION HOURS

Homeopathic Dilution Unit Hour; hr

Homeopathic Dilution Unit Hour

C67274

HPF

High Power Field

High Power Field

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 482 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Henry

NCI Code C42558

CDISC Submission Value Henry

CDISC Definition A unit of electric inductance. A coil with an inductance of one Henry requires a flux of one Weber for each Ampere of induced current. If it is the current which changes, then the induced field will generate a potential difference within the coil: if the inductance is one Henry a current change of one Ampere per second generates a potential difference of one volt. The Henry is a large unit; inductances in practical circuits are measured in millihenrys or microhenrys.(NCI) A unit of frequency equal to one cycle per second.(NCI) A dosing measurement based on the implant unit.(NCI) A traditional unit of length equal to 2.54 centimeters. (NCI) A dosing measurement based on the inhalation unit.(NCI) The unitage assigned by the WHO (World Health Organization) to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization (e.g. hormones, enzymes, and vaccines), to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.(NCI) Unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one international unit per one liter of system volume.(NCI) A unit of measure of quantity of substance per unit mass, expressed in terms of the International Unit per grams.(NCI) An arbitrary unit of substance content expressed in international units of biological activity per one kilogram of mass of the system. It is also used as a dose calculation unit expressed in international units of biological activity per one kilogram of body mass.(NCI) A dose calculation unit equal to one international unit (an arbitrary unit of biological activity) of a product per one kilogram of body mass administered per unit of time equal to one hour.(NCI) Unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one international unit per one milliliter of system volume.(NCI) Henry

NCI Preferred Term

C42545 C48499 C48500 C48501 C48579

Hz IMPLANT IN INHALATION IU

Hertz Implant Dosing Unit Inch Inhalation Dosing Unit International Unit

Hertz Implant Dosing Unit Inch Inhalation Dosing Unit International Unit

C67376

IU/L

International Unit per Liter; IU/L; mIU/mL International Unit per Gram International Unit per Kilogram

International Unit per Liter

C70493

IU/g

International Unit per Gram

C67379

IU/kg

International Unit per Kilogram

C71209

IU/kg/h

International units per Kilogram per Hour International Unit per Milliliter; kIU/L; Kilo International Unit per Liter

International Unit per Kilogram per Hour

C67377

IU/mL

International Unit per Milliliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 483 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym International Unit per Milligram Jar Dosing Unit Joule

NCI Code C67380

CDISC Submission Value IU/mg

CDISC Definition Unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one international unit per one milligram of substance.(NCI) A dosing measurement based on the jar unit.(NCI) A unit of electrical, mechanical, and thermal energy (as well as work and quantity of heat), equal to the work done when the point of application of a force of one Newton is displaced through a distance of one meter in the direction of the force or the work done when a current of one Ampere passes through a resistance of one ohm for one second. One joule is equal to 0.23889 gram-calorie (mean).(NCI) A dosing measurement based on the Kallikrein inhibitor unit.(NCI) A dosing measurement based on the kit unit.(NCI) A unit of volume equal to a cubic decimeter, or one thousandth of cubic meter, or 1000 cubic centimeters, or approximately 61.023 744 cubic inches.(NCI) Liters per hour.

NCI Preferred Term International Unit per Milligram

C48502 C42548

JAR Joule

Jar Dosing Unit Joule

C48503 C48504 C48505

KALLIKREIN INHIBITOR UNIT KIT L

Kallikrein Inhibitor Unit Kit Dosing Unit Liter

Kallikrein Inhibitor Unit Kit Dosing Unit Liter

C69160 C73725 C67388

L/h L/kg L/min Liter per Kilogram Liters per Minute L/sec Pound

Liter per Hour L/kg Liter per Minute

A dose calculation unit expressed in liter(s) per kilogram. (NCI) A unit of volumetric flow rate defined as the rate at which one liter of matter travels during the period of time equal to one minute.(NCI) Liters per second. A traditional unit of mass. By international agreement, one avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI) A dosing measurement based on the lozenge unit.(NCI) The area visible in one view field of the microscope under the low magnification of the objective being used in microscopy.(NCI) A logarithmic-scale (base 10) unit for measuring concentration and/or reactivity of a test substance (an antigen or antibody of interest) as defined in the literature reference for the particular quantitative enzyme-linked immunosorbent assay method.(NCI) A logarithmic-scale (base 10) unit for measuring potency of immunologically active substance in a product determined as reactivity in a quantitative immunoassay for particular antigen or antibody and expressed per quantity of preparation used as a single dose.(NCI) A unit of radioactivity equal to one million nuclear disintegrations or other nuclear transformations per second, or to 10E6 Becquerels.(NCI)

C67390 C48531

L/s LB

Liter per second Pound

C48506 C67307

LOZENGE LPF

Lozenge Dosing Unit Low Power Field

Lozenge Dosing Unit Low Power Field

C68878

Log10 ELISA unit

Log10 Enzyme-Linked Immunosorbent Assay Unit Log10 Enzyme-Linked Immunosorbent Assay Unit per Dose Megabecquerel

Log10 Enzyme-Linked Immunosorbent Assay Unit

C68879

Log10 ELISA unit/dose

Log10 Enzyme-Linked Immunosorbent Assay Unit per Dose

C70512

MBq

Megabecquerel

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 484 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Megabecquerel per Microliter; GBq/mL; Gigabecquerel per Milliliter Molecules of Equivalent Soluble Fluorochromes Median Fluorescence Intensity Megahertz Month

NCI Code C71169

CDISC Submission Value MBq/uL

CDISC Definition A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one million Becquerels per unit volume equal to one millionth of a liter.(NCI) A unit of measure of the fluorescence intensity of a fluorochrome-labeled sample, which is equivalent to the fluorescence intensity of a solution containing an equivalent number of molecules of free fluorochrome in solution, under identical experimental conditions. A unit of measure equal to the geometric mean fluorescence intensity of a log-normal distribution of fluorescence signals. The SI derived unit of frequency; equal to one million oscillations per second or to 10E6 hertz. (NCI) One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI) A unit of distance equal to 5280 international feet, 1760 international yards, or 1609.344 meters.(NCI) A unit of measurement based on the nebule dosing unit.(NCI) A unit of force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter per second squared. It is equal to 10E5 dynes.(NCI) A number of individual items packaged as a unit.

NCI Preferred Term Megabecquerel per Microliter

C96691

MESF

Molecule of Equivalent Soluble Fluorochrome

C96687

MFI

Median Fluorescence Intensity

C67314 C29846

MHz MONTHS

MHz Month

C71183 C71204 C42546

Mile NEBULE Newton

International Mile Nebule Newton

Mile Nebule Dosing Unit Newton

C62653 C48520

PACK PACKAGE Package Dosing Unit; Pack Dosing Unit Packet Dosing Unit Patch Dosing Unit Pellet Dosing Unit Plaque Forming Unit

Pack Package Dosing Unit

A dosing measurement based on the package unit.(NCI) A dosing measurement based on the packet unit.(NCI) A dosing measurement based on the patch unit.(NCI) A dosing measurement based on the pellet unit.(NCI) A measure of viable infectious entities (e.g. viral particle or group of particles) in the specimen or product defined as the smallest quantity that can produce a cytopathic effect in the host cell culture challenged with the defined inoculum, visible under the microscope or/and to the naked eye as a plaque. A number of plaque forming units (PFU) per unit volume is a conventional way to refer the titer of an infective entity in a specimen or preparation.(NCI) A unit of potency of a biological product expressed as a quantity of viable infectious entities capable to produce a cytopathic effect in the appropriate cell culture per a single dose of the preparation.(NCI)

C48521 C48524 C48525 C67264

PACKET PATCH PELLET PFU

Packet Dosing Unit Patch Dosing Unit Pellet Dosing Unit Plaque Forming Unit

C71198

PFU/dose

Plaque Forming Unit per Dose

Plaque Forming Unit per Dose

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 485 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Plaque Forming Unit per Milliliter Pouch Dosing Unit Pressor Unit Puff

NCI Code C71199

CDISC Submission Value PFU/mL

CDISC Definition A unit of potency of a biological product expressed as a quantity of viable infectious entities capable to produce a cytopathic effect in the appropriate cell culture per one milliliter of the preparation.(NCI) A dosing measurement based on the pouch unit.(NCI) A dosing measurement based on the pressor unit.(NCI) A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) A unit of pressure equivalent to one Newton per square meter or 10 bars or to 1.45x10(E-4) pounds per square inch.(NCI) A quantification of lifetime tobacco exposure defined as (number of cigarettes smoked per day x number of years smoked)/20. One pack-year is smoking 20 cigarettes a day for one year.

NCI Preferred Term Plaque Forming Unit per Milliliter

C48530 C48532 C65060

POUCH PRESSOR UNITS PUFF

Pouch Dosing Unit Pressor Unit Puff Dosing Unit

C42547

Pa

Pascal

Pascal

C73993

Pack Year

Pack Year

C48590

QUANTITY SUFFICIENT

Quantity Sufficient

A quantity of an ingredient or product needed to bring up a volume or weight of the preparation to a final amount as it is indicated in the prescription; also refers to a determination of an adequate supply of medicine to fulfill either a prescribed amount or a sufficient quantity to provide treatment over a specified time frame.(NCI) A unit of measurement for the quotient of the amount of one entity to another.

Quantity Sufficient

C44256 C62609 C67441

RATIO RING RNA copies/mL Ring Dosing Unit RNA Copies per Milliliter Rad

Ratio Ring Dosing Unit RNA Copy per Milliliter

A dosing measurement based on the ring unit.(NCI) The unit of concentration of Ribonucleic Acid (RNA) copies expressed as a number of copies in unit volume equal to one milliliter.(NCI) The special unit for absorbed radiation dose, which is the amount of energy from any type of ionizing radiation (e.g., alpha, beta, gamma, neutrons, etc.) deposited in any medium (e.g., water, tissue, air). A dose of one rad means the absorption of 100 ergs per gram of absorbing tissue. One rad is equal to 0.01 gray.(NCI) A unit of exposure to ionizing radiation. One Roentgen is the amount of gamma or x-rays required to produce ions resulting in a charge of 2.58E-4 Coulombs/kilogram of air under standard conditions.(NCI) A dosing unit that contains a solid pharmaceutical preparation in the form of a small packet or bag made from a flexible, often porous material.(NCI) A dosing measurement based on the scoopful unit.(NCI)

C18064

Rad

Rad

C70575

Roentgen

Roentgen

Roentgen

C71324

SACHET

Sachet dosing unit Scoopful Dosing Unit

Sachet Dosing Unit

C48536

SCOOPFUL

Scoopful Dosing Unit

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 486 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Spray Dosing Unit Strip Dosing Unit Suppository Dosing Unit Syringe Dosing Unit Siemens

NCI Code C48537 C48538 C48539 C48540 C42555

CDISC Submission Value SPRAY STRIP SUPPOSITORY SYRINGE Siemens

CDISC Definition A dosing measurement based on the spray unit.(NCI) A dosing measurement based on the strip unit.(NCI) A dosing measurement based on the suppository unit.(NCI) A dosing measurement based on the syringe unit.(NCI) A unit of electrical conductance, admittance, and susceptance. A conductor has a conductance of one Siemens if an electrical potential difference of one volt produces a one Ampere current in it. The conductance in Siemens is the reciprocal of its resistance in ohms.(NCI) A unit of equivalent radiation dose. One Sv is received when the actual absorbed dose of ionizing radiation, after being multiplied by the dimensionless factors Q (the relative biological efficiency or quality factor) and N (the product of any other multiplying factors that takes into account the distribution of energy throughout the dose), is one joule per kilogram. In this scheme, the relationship between the absorbed dose of radiation D and the dose equivalent H is, therefore, given by H = QND. Both Q and N are stipulated by the International Commission on Radiological Protection. One Sv is equal to 100 rem.(NCI) A dosing measurement based on the tablet unit.(NCI) A dosing measurement based on the tampon unit.(NCI) A potency unit equal to the potency at which one dose of preparation contains one 50 percent tissue culture infective dose.(NCI) An extremely small amount.(NCI) A dosing measurement based on the troche unit.(NCI) A dosing measurement based on the tube unit.(NCI) A unit of volume informally used in pharmacy. The tablespoon has been standardized at 15 milliliters in US, Britain, Canada, and New Zealand, and at 20 milliliters in Australia and some European countries.(NCI) A unit of magnetic flux density equal to the magnitude of the magnetic field vector necessary to produce a force of one Newton on a charge of one coulomb moving perpendicular to the direction of the magnetic field vector with a velocity of one meter per second. It is equivalent to one Weber per square meter.(NCI)

NCI Preferred Term Spray Dosing Unit Strip Dosing Unit Suppository Dosing Unit Syringe Dosing Unit Siemens

C42553

Sv

Sievert

Sievert

C48542 C48543 C70537

TABLET TAMPON TCID 50/dose

Tablet Dosing Unit; tab Tampon Dosing Unit 50 Percent Tissue Culture Infective Dose per Dose Trace Dosing Unit Troche Dosing Unit Tube Dosing Unit Tablespoon Dosing Unit

Tablet Dosing Unit Tampon Dosing Unit 50 Percent Tissue Culture Infective Dose per Dose

C48547 C48548 C48549 C48541

TRACE TROCHE TUBE Tbsp

Trace Dosing Unit Troche Dosing Unit Tube Dosing Unit Tablespoon Dosing Unit

C42557

Tesla

Tesla

Tesla

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 487 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Unit mU/mL; Unit per Liter Unit per Animal Unit per Gram Unit per Gram per Day Unit per Gram per Hour Unit per Gram per Minute Unit per Kilogram

NCI Code C44278 C67456

CDISC Submission Value U U/L

CDISC Definition A single undivided thing occurring in the composition of something else. An arbitrary unit of substance concentration equal to the concentration at which one liter of mixture contains one unit of a substance. (NCI) An arbitrary dosing unit expressed in unit(s) per animal. (NCI) An arbitrary unit of substance content expressed in unit(s) per gram. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to twenty-four hours. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty minutes. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty seconds. (NCI) An arbitrary unit of substance content expressed in units of biological activity per unit of mass equal to one kilogram. Unit per kilogram is also used as a dose calculation unit expressed in arbitrary units per one kilogram of body mass. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to twenty-four hours. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty minutes. (NCI) An arbitrary unit of substance rate expressed in unit(s) per gram per period of time equal to sixty seconds. (NCI) A unit expressed as a number of arbitrary units of substance per one square meter of a body surface area. An arbitrary unit of substance rate expressed in unit(s) per square meter per period of time equal to twenty-four hours. (NCI) An arbitrary unit of substance rate expressed in unit(s) per square meter per period of time equal to sixty minutes. (NCI) An arbitrary unit of substance rate expressed in unit(s) per square meter per period of time equal to sixty seconds. (NCI) An arbitrary unit of substance content expressed in unit(s) per milliliter. (NCI) An arbitrary unit of substance content expressed in unit(s) per milligram. (NCI) U

NCI Preferred Term

Unit per Liter

C73773 C77606 C73774

U/animal U/g U/g/day

U/animal Unit per Gram U/g/day

C73775

U/g/h

U/g/h

C73776

U/g/min

U/g/min

C67465

U/kg

Unit per Kilogram

C73777

U/kg/day

Unit per kilogram per Day Unit per Kilogram per Hour Unit per Kilogram per Minute Unit per Square Meter Unit per Square Meter per Day Unit per Square Meter per Hour Unit per Square Meter per Minute Unit per Milliliter Unit per Milligram

U/kg/day

C73778

U/kg/h

U/kg/h

C73779

U/kg/min

U/kg/min

C67467 C73783

U/m2 U/m2/day

U/m2 U/m2/day

C73784

U/m2/h

U/m2/h

C73785

U/m2/min

U/m2/min

C77607 C73780

U/mL U/mg

Unit per Milliliter Unit per Milligram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 488 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Unit per Millimole Volt

NCI Code C92618

CDISC Submission Value U/mmol

CDISC Definition An arbitrary unit of substance concentration equal to the concentration at which one millimole of a mixture contains one unit of a substance. (NCI) A unit of electric potential and electromotive force, equal to the difference of electric potential between two points on a conducting wire carrying a constant current of one Ampere when the power dissipated between the points is one watt. This is equivalent to the potential difference across a resistance of one ohm when one Ampere of current flows through it.(NCI) A dosing measurement based on the vial unit.(NCI) A dosing measurement based on the wafer unit.(NCI) Any period of seven consecutive days. (NCI) A unit of power equal to the power which in one second produces or transfers the energy of one joule. The unit is used in measurements of power emitted, transferred or received as radiation, sound waves, heat flow rate, and rate of energy transfer. Equal to 1/746 of horsepower.(NCI) A unit of magnetic flux, equal to the flux that produces in a circuit of one turn an electromotive force of one volt, when the flux is uniformly reduced to zero within one second.(NCI) The period of time that it takes for earth to make a complete revolution around the sun, approximately 365 days; a specific one year period.(NCI) A unit of mass equal to one quintillionth of a gram (10E-18 gram).(NCI) A unit of amount of substance equal to one quintillionth of a mole (10E-18 mole).(NCI) A unit of electric current, named after the French physicist Andre Ampere. It is that constant current which, if maintained in two straight parallel conductors of infinite length and zero diameter separated by one meter in a vacuum, would produce between these conductors a force equal to 2(10E7) Newton per meter of length. This is dependent upon the definitions of the meter, kilogram, and second. One Ampere represents 6.24 x 10(E18) unit electric charge carriers, such as electrons, passing a specified fixed point in one second.(NCI) A small unit of mass used to express atomic and molecular masses. (NCI) A unit of unfractionated or low molecular weight heparin anticoagulation potency determined as the amount that neutralizes one unit of coagulation factor Xa preparation defined as an international biological standard by WHO (World Health Organization) First International Low Molecular Weight Heparin Reference Standard.(NCI)

NCI Preferred Term U/mmol

C42551

Volt

C48551 C48552 C29844 C42549

VIAL WAFER WEEKS Watt

Vial Dosing Unit Wafer Dosing Unit Week Watt

Vial Dosing Unit Wafer Dosing Unit Week Watt

C42556

Weber

Weber

Weber

C29848

YEARS

Year

Year

C64553 C68855 C42536

ag amol amp

Attogram Attomole Ampere

Attogram Attomole Ampere

C64559 C70497

amu anti-Xa IU

Atomic Mass Unit Anti-Xa Activity International Unit

amu Anti-Xa Activity International Unit

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 489 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Anti-Xa Activity International Unit per Milliliter Atmosphere

NCI Code C70498

CDISC Submission Value anti-Xa IU/mL

CDISC Definition A specific anticoagulation activity of unfractionated or low molecular weight heparin on factor Xa, expressed as a number of international anti-Xa heparin units per one milliliter of plasma.(NCI) A unit of pressure, equal to a barometer reading of 760 mm Hg. 1 atmosphere is 101325 Pascals and 1.01325 bar. This unit of pressure is roughly equal to the average atmospheric pressure at sea level on the earth.(NCI) A logarithmic ratio unit (base-10 logarithms) used to express relative magnitude of a physical quantity (usually power or intensity) in comparison with a specified or implied reference level. Particularly, Bel is used as a unit of relative sound intensity. In the latter context it is equal to ten decibels or to approximately 1.151293 nepers.(NCI) A measurement of nutritional energy. The quantity of thermal energy required to raise one gram of water one degree Centigrade under standard conditions. 1 calorie equals 4.186 joules. (NCI) The candela is the basic unit of luminous intensity. It is the luminous intensity in a given direction of a small monochromatic light source at 540 terahertz emitting 1/683 watt per steradian in that direction. This is dependent upon the definitions of the meter, kilogram, and second.(NCI) A unit of mass equal to one hundredth of a gram.(NCI) A basic unit of length equal to one hundredth of a meter or approximately 0.393 700 787 inch. (NCI) A unit of pressure defined by a column of water with a height of one centimeter, frequently used to measure central venous pressure, intracranial pressure, and for pressures during mechanical ventilation.

NCI Preferred Term Anti-Xa Activity International Unit per Milliliter

C54711

atm

Atmosphere

C71200

bel

Bel

Bel

C67193

cal

Calorie

calorie

C42538

cd

Candela

Candela

C64554 C49668 C91060

cg cm cm H2O

Centigram Centimeter

Centigram Centimeter Centimeters of Water

C102406

cm/s

cm/sec

A unit of both speed (scalar) and velocity (vector), defined as the distance of one centimeter travelled per unit time equal to one second. (NCI) A unit of area measurement equal to a square measuring one centimeter on each side. One square centimeter is equal to 10E-4 square meter.(NCI) A unit of amount of substance equal to one hundredth of a mole (10E-2 mole).(NCI) A unit of concentration expressed as a number of copies per unit volume equal to one milliliter.

Centimeter per Second

C48460

cm2

Square Centimeter Centimole

Square Centimeter

C68687 C100900 C71176

cmol copies/mL cycle/min

Centimole Copies per Milliliter Cycle per Minute

Cycle per Minute

A unit of frequency equal to the frequency at which one complete execution of a periodically repeated phenomenon, alternation, event, or sequence of events occurs per unit of time equal to one minute.(NCI) A unit of frequency equal to the frequency at which one complete execution of a periodically repeated phenomenon, alternation, event, or sequence of events occurs per unit of time equal to one second.(NCI)

C71480

cycle/sec

Cycle per Second

Cycle per Second

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 490 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Decibel

NCI Code C102407

CDISC Submission Value dB

CDISC Definition A unit of measure representing the intensity of an electrical signal or sound which is equal to ten times the logarithm of the ratio of two signals. The unit of volume equal to one tenth of a liter. Accepted for use with the SI. (NCI) A unit of plane angle measurement equal to the length of the arc cut out by the angle, divided by the circumference of the circle, and multiplied by 360. The symbol for degrees is a small superscript circle. One radian is about 57 degrees and one degree is pi/180 radians.(NCI) A unit of amount of substance equal to one tenth of a mole (10E-1 mole).(NCI) A unit of mass equal to 1/16 Avoirdupois ounce or 1/256 Avoirdupois pound. One dram equals approximately 1.7718451953125 grams.(NCI) A unit of force defined as the force that accelerates a mass of one gram at the rate of one centimeter per second squared. One dyne is equal to 10E-5 Newton and 2.248E-6 pounds of force.(NCI) A unit of relative amount of a substance that combines with or displaces 8.0 grams of oxygen or 1.008 gram of hydrogen. The unit is usually expressed in grams and is equal to the amount of substance that gains or loses one mole of electrons in a redox reaction, or to the amount of substances that releases or accepts one mole of hydrogen ions in a neutralization reaction; or to the amount of electrolyte that carries one mole of positive or negative charge. This is a large unit and measurements are more often done in its derivatives, e.g. in milliequivalents.(NCI) The unit of volume equal 10E-15 liter. A unit of mass equal to one quadrillionth of a gram (10E-15 gram).(NCI) A unit of amount of substance equal to one quadrillionth of a mole (10E-15 mole).(NCI) A unit of concentration (molarity unit) equal to one quadrillionth of a mole (10E-15 mole) of solute in one liter of solution. (NCI) A molality unit that describes the amount of substance, expressed in femtomole(s) per gram. (NCI) A unit of length defined by the U.S. National Bureau of Standards as 30.48 centimeters. It is equal to 0.3048 meter, 12 inches, or to approximately 0.999998 survey foot.(NCI) A unit of area equal to 144 square inches, 929.0304 square centimeters, or 9.290304E-2 square meters.(NCI)

NCI Preferred Term Decibel

C64697 C68667

dL deg

Deciliter Degree Unit of Plane Angle

dL Degree Unit of Plane Angle

C68685 C64564

dmol dram

Decimole Dram

Decimole Dram Mass Unit

C70470

dyn

Dyne

Dyne

C67273

eq

Equivalent Weight

Equivalent Weight

C64780 C64552 C68854 C68887

fL fg fmol fmol/L

Femtoliter Femtogram Femtomole Femtomole per Liter Femtomole per Gram Foot

Femtoliter Femtogram Femtomole fmol/L

C73711 C71253

fmol/g ft

fmol/g International Foot

C48461

ft2

Square Foot

Square Foot

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 491 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Standard Cubic Foot

NCI Code C68859

CDISC Submission Value ft3

CDISC Definition A unit used in physical chemistry to express the amount of substance of an ideal gas in one cubic foot at 60 degrees Fahrenheit and pressure of one atmosphere.(NCI) A metric unit of mass equal to one one thousandth of a kilogram. (NCI) A unit of mass concentration defined as the concentration of one kilogram of a substance per unit volume of the mixture equal to one cubic meter, or the concentration of one milligram of a substance per unit volume of the mixture equal to one milliliter, or one gram of a substance per one liter of the mixture. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one milliliter.(NCI) A unit of measure expressed in gram(s) per animal. A unit of measure expressed in gram(s) per animal per period of time equal to twenty-four hours. A unit of measure expressed in gram(s) per animal per period of time equal to seven days. A unit of measure expressed in gram(s) per cage. A unit of measure expressed in gram(s) per cage per period of time equal to twenty-four hours. A unit of measure expressed in gram(s) per cage per period of time equal to seven days. A unit of area density defined as a spread rate at which one gram of a substance is spread over the area of one square centimeter. The unit is also used as a dose calculation unit.(NCI) A unit of mass concentration defined as the concentration of one gram of a substance per unit volume of the mixture equal to one deciliter (100 milliliters). The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which mass equal to one gram occupies the volume one deciliter.(NCI) A dose calculation unit expressed in gram(s) per period of time equal to twenty-four hours. A unit of a mass fraction expressed as a number of grams of substance per gram of mixture. A unit of measure expressed in gram(s) per gram per period of time equal to twenty-four hours. A unit of a mass fraction expressed as a number of grams of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI)

NCI Preferred Term Standard Cubic Foot

C48155 C42576

g g/L

Gram g/L; Gram per Liter; kg/m3; Kilogram per Cubic Metre; Microgram per Microliter; Milligram per Milliliter; ug/uL; mg/mL Gram per Animal Gram per Animal per Day Gram per Animal per Week Gram per Cage Gram per Cage per Day Gram per Cage per Week Gram per Square Centimeter

Gram Kilogram per Cubic Meter

C73713 C73714 C73715 C73716 C73717 C73718 C71201

g/animal g/animal/day g/animal/wk g/cage g/cage/day g/cage/wk g/cm2

g/animal g/animal/day g/animal/week g/cage g/cage/day g/cage/week Gram per Square Centimeter

C64783

g/dL

Gram per Deciliter; g%

Gram per Deciliter

C67372 C70453 C73720 C69104

g/day g/g g/g/day g/kg

Gram per Day Gram per Gram Gram per Gram per Day Gram per Kilogram; mg/g; Milligram per Gram

Gram per 24 Hours g/g g/g/day Gram per Kilogram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 492 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Gram per Kilogram per Day Gram per Square Meter

NCI Code C66975

CDISC Submission Value g/kg/day

CDISC Definition A dose administration rate unit equal to the rate at which one gram of a product per kilogram of body mass is delivered or administered over the period of one day. (NCI) A unit of area density defined as a spread rate at which one gram of a substance is spread over the area of one square meter. It is equal to approximately 0.029 4935 ounce per square yard. Also used as a dose calculation unit.(NCI) A dose calculation unit expressed in gram(s) per square meter per period of time equal to twenty-four hours. A unit of mass commonly used to express the molar mass of a substance in gram(s) per mole. (NCI) A unit of mass derived from the weight of a grain and equal to one seven-thousandth of a pound, or 1/480 troy ounce, or 64.79891 milligrams. The original English grain unit based on the mass of a ripe grain barleycorn was larger the corresponding grain units of France and other European nations which were based on the weight of the smaller wheat grain.(NCI) A unit of volume equal to 0.05 milliliter (20 drops/ml).(NCI) A unit of area equal to the area of a square with sides of one inch. It is equal to 6.4516 square centimeters.(NCI) A unit of radioactivity equal to one thousand nuclear disintegrations or other nuclear transformations per second, or to 10E3 Becquerels.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one thousand Becquerels per unit volume equal to one millionth of a liter.(NCI)

NCI Preferred Term g/kg/day

C67282

g/m2

Gram per Square Meter

C73722

g/m2/day

Gram per Square Meter per Day Gram per Mole Grain

g/m2/day

C73721 C48497

g/mol grain

g/mol Grain

C69442 C68871

gtt in2

Drop Square Inch

Medical Drop Square Inch

C70511

kBq

Kilobecquerel

Kilobecquerel

C71168

kBq/uL

Kilobecquerel per Microliter; GBq/L; Gigabecquerel per Liter; MBq/mL; Megabecquerel per Milliliter Kilo International Unit Kilonewton per Centimeter Squared; kdyn/cm2

Kilobecquerel per Microliter

C70492

kIU

A unit equal to one thousand international units.(NCI)

Kilointernational Unit

C92615

kN/cm2

The kilonewton per centimeter squared is an SI derived unit of pressure; one newton is computed as the force necessary to accelerate a mass of one gram at the rate of one centimeter per second squared. One kilonewton per centimeter squared is descriptive of the amount of force exerted in a particular area. This measurement is frequently used when describing conditions of cellular movement. (NCI) A SI derived unit of pressure equivalent to 1000 newtons per square meter or 10000 bars or to 0.145 pound per square inch. (NCI)

Kilonewton per Centimeter Squared

C67284

kPa

Kilopascal

kPa

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 493 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Kilo United States Pharmacopoeia Unit Katal

NCI Code C71202

CDISC Submission Value kUSP

CDISC Definition A unit of potency equal to one thousand US Pharmacopoeia Units.(NCI)

NCI Preferred Term Kilo United States Pharmacopeia Unit

C42566

kat

A unit for measuring catalytic (e.g. enzymatic) activity, the ability of the compound to accelerate the chemical reaction by providing a lower energy pathway between the reactants and the products. One katal is that catalytic activity which will raise the rate of reaction by one mole per second in a specified assay system. When the katal is used, the measurand should be specified by reference to the measurement procedure; the measurement procedure must identify the indicator reaction. The katal is not used to express a rate of reaction itself, which should be expressed in moles per second.(NCI) A unit of energy defined as the amount of heat required to raise the temperature of one kilogram of pure water by one degree Centigrade under standard conditions (the specific heat of the water at 15 degrees Celsius and the constant pressure of 101.325 kilopascals or one atm being defined as unity), equal to approximately 4.1855 kJ. It is also is used by nutritionists in measuring the energy-producing potential of food as a unit of potential energy contained by a substance, which can be liberated when the material is oxidized, usually by combustion in the presence of oxygen.(NCI) The basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in terms of a material object, and also the only one with a prefix [kilo] already in place. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds. (NCI) A unit of mass concentration defined as the concentration of one kilogram of a substance in unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one kilogram occupies the volume one liter.(NCI) A unit of spread rate of a substance by mass expressed in kilograms per area unit equal to one square centimeter, used also as a measure of area density and as a dose calculation unit.(NCI) A unit expressed as kilogram of mass per square meter of area.(NCI) A unit of distance equal to 1000 meters, 0.621 miles, 1094 yards, or 3281 feet.(NCI) A unit of both speed (scalar) and velocity (vector), defined as the distance of one thousand meters travelled per unit time equal to one hour.(NCI)

Katal

C67194

kcal

Kilogram-Calori e

Calorie

C28252

kg

Kilogram

Kilogram

C64566

kg/L

Kilogram per Liter; g/mL; Gram per Milliliter; gram/mL; kg/L; mg/uL Kilogram per Square Centimeter Kilogram per Square Meter Kilometer Kilometer Per Hour

Kilogram per Liter

C69094

kg/cm2

Kilogram Per Square Centimeter

C49671 C71177 C71203

kg/m2 km km/h

Kilogram Per Square Meter Kilometer Kilometer per Hour

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 494 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Lumen

NCI Code C42560

CDISC Submission Value lm

CDISC Definition A unit of luminous flux. It is the amount of light that falls on a unit area at unit distance from a source of one candela.(NCI) A logarithmic-scale (base 10) potency unit for measuring infectious activity of a biologic product or infectious agent preparation equal to the potency at which one dose of infectious material contains one 50 percent embryo infective dose.(NCI) A potency unit for measuring infectious activity of a biologic product or infectious agent preparation equal to a base-10 logarithm of amount of product or agent preparation that causes infection in the 50% of the cell culture-containing vessels inoculated with that dilution of infectious material in the product potency assay or pathogen activity assay.(NCI) A logarithmic-scale (base 10) potency unit for measuring infectious activity of a biologic product or infectious agent preparation equal to the potency at which one dose of infectious material contains one 50 percent cell culture infective dose.(NCI) A potency unit for measuring infectious activity of a biologic product or infectious agent equal to a base-10 logarithm of amount of product or agent preparation that causes infection in the 50% of embryos (such as chicken embryos) used in the product potency assay or pathogen activity assay.(NCI) A potency unit for measuring infectious activity of a biologic product or infectious agent preparation equal to a base-10 logarithm of amount of product or agent preparation that causes infection in the 50% of the tissue culture-containing flasks inoculated with that dilution of infectious material in the product potency assay or pathogen activity assay.(NCI) A logarithmic-scale (base 10) potency unit for measuring infectious activity of a biologic product or infectious agent preparation equal to the potency at which one dose of infectious material contains one 50 percent tissue culture infective dose.(NCI) A unit of illuminance equal to the direct illumination on a surface that is everywhere one meter from a uniform point source of one candela; a unit of illuminance that is equal to one lumen per square meter.(NCI) A meter is defined as the length of the path traveled by light in a vacuum during a time interval of 1/299 792 458 of a second and is equal to 1.093 61 yards.(NCI) A unit of both speed (scalar) and velocity (vector), defined as the distance of one meter travelled per unit time equal to one second.(NCI) The SI unit of area measurement equal to a square whose sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 are; 1.196 square yards; 10.76 square feet; 1550 square inches. (NCI) Lumen

NCI Preferred Term

C70480

log EID 50/dose

Log10 50 Percent Embryo Infective Dose per Dose Log10 50 Percent Cell Culture Infective Dose

Log10 50 Percent Embryo Infective Dose per Dose

C70484

log10 CCID 50

Log10 50 Percent Cell Culture Infective Dose

C70485

log10 CCID 50/dose

Log10 50 Percent Cell Culture Infective Dose per Dose Log10 50 Percent Embryo Infective Dose

Log10 50 Percent Cell Culture Infective Dose per Dose

C70479

log10 EID 50

Log10 50 Percent Embryo Infective Dose

C70488

log10 TCID 50

Log10 50 Percent Tissue Culture Infective Dose

Log10 50 Percent Tissue Culture Infective Dose

C70489

log10 TCID 50/dose

Log10 50 Percent Tissue Culture Infective Dose per Dose Lux

Log10 50 Percent Tissue Culture Infective Dose per Dose

C42561

lx

Lux

C41139

Meter

Meter

C42571

m/sec

Meter Per Second Square Meter

Meter Per Second

C42569

m2

Square Meter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 495 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Cubic Meter

NCI Code C42570

CDISC Submission Value m3

CDISC Definition A unit of volume or capacity equal to the volume of a cube with edges one meter in length. It is equal to 1,000 liters; 1,000 cubic decimeters; 10(E6) cubic centimeters; 25.3 cubic feet; 6.29 barrels.(NCI) A unit of radioactivity equal to one thousandth of a Curie or 37 megabecquerels, and corresponding to a radioactivity of 37 millions of atomic disintegrations per second.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one thousandth of a Curie per unit volume equal to one liter.(NCI) A unit of specific radioactivity (massic activity) equal to activity of one millicurie of the sample with total mass of one kilogram.(NCI) A unit of relative amount of a substance equal to one thousandth of an equivalent weight.(NCI) A concentration unit measured as a number of milliequivalents of solute per liter of solution.(NCI)

NCI Preferred Term Cubic Meter

C48511

mCi

Millicurie

Millicurie

C71174

mCi/L

Millicurie per Liter; uCi/mL; Microcurie per Milliliter Millicurie per Kilogram; uCi/g; Microcurie per Gram Milliequivalent Milliequivalent Per Liter; mval/L; Millivalent per Liter Milliequivalent per Deciliter Milliequivalents per Day

Millicurie per Liter

C70570

mCi/kg

Millicurie per Kilogram

C48512 C67474

mEq mEq/L

Milliequivalent Milliequivalent per Liter

C67473

mEq/dL

A concentration unit measured as a number of milliequivalents of solute per deciliter of solution. (NCI) A unit of relative amount of substance flow rate equivalent to the rate at which one thousandth of an equivalent of substance travels to a given object or space over a period of time equal to twenty four hours.(NCI) A unit of relative amount of substance content equivalent to the content at which one gram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) A unit of relative amount of substance content equivalent to the content at which one kilogram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) A concentration unit expressed in milliequivalent(s) of solute per milliliter of solution. (NCI) A concentration unit measured as a number of one thousandth of an equivalent weight per millimole of substance. (NCI) A concentration unit measured as a number of milliequivalents of solute per microliter of solution.(NCI)

mEq/dL

C67471

mEq/day

Milliequivalent per 24 Hours

C70580

mEq/g

Milliequivalent Per Gram

Milliequivalent per Gram

C67475

mEq/kg

Milliequivalent Per Kilogram

Milliequivalent per Kilogram

C73737 C92616

mEq/mL mEq/mmol

Milliequivalent per Milliliter Milliequivalent per Millimole Milliequivalent Per Microliter

mEq/mL Milliequivalent per Milliimole

C70578

mEq/uL

Milliequivalent per Microliter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 496 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Milliequivalent Per Microgram; mEq/mcg

NCI Code C70581

CDISC Submission Value mEq/ug

CDISC Definition A unit of relative amount of substance content equivalent to the content at which one millionth of a gram of mixture contains one thousandth of an equivalent of a component. The unit is also used as a dose calculation unit.(NCI) The unit of volume equal to one thousandth of a liter, one cubic centimeter, 10E-6 cubic meter, or approximately to 0.061 023 7 cubic inch.(NCI) A unit of measure expressed in milliliter(s) per animal. A unit of measure expressed in milliliter(s) per animal per period of time equal to twenty-four hours. A unit of measure expressed in milliliter(s) per animal per period of time equal to seven days. A unit of measure expressed in milliliter(s) per inspiration or expiration of breath. A unit of measure expressed in milliliter(s) per cage. A unit of measure expressed in milliliter(s) per cage per period of time equal to twenty-four hours. A unit of measure expressed in milliliter(s) per cage expressed per period of time equal to seven days. A unit of pressure expressed in milliliter(s) per centimeter of water. (NCI)

NCI Preferred Term Milliequivalent per Microgram

C28254

mL

Milliliter; cm3

Milliliter

C73746 C73747 C73748 C73749 C73750 C73751 C73752 C98755 C73753 C73754 C73755

mL/animal mL/animal/day mL/animal/wk mL/breath mL/cage mL/cage/day mL/cage/wk mL/cm H2O mL/day mL/g mL/g/day

Milliliter per Animal Milliliter per Animal per Day Milliliter per Animal per Week Milliliter per Breath Milliliter per Cage Milliliter per Cage per Day Milliliter per Cage per Week

mL/animal mL/animal/day mL/animal/week mL/breath mL/cage mL/cage/day mL/cage/week Milliliter per Centimeter of Water mL/day mL/g Milliliter per Gram per Day

Milliliter per Day Milliliter per Gram Milliliter per Gram per Day; mL/g/day; uL/mg/day; L/day/kg; mL/day/g; uL/day/mg; L/kg/d Milliliter per Gram per Hour Milliliter per Gram per Minute Milliliters per Hour Milliliter per Kilogram Milliliter per Kilogram per Day

Milliliters per day. A unit of measure expressed in milliliter(s) per gram. Liters per kilogram per day.

C73756 C73757 C66962

mL/g/h mL/g/min mL/h

Milliliters per gram per hour. Milliliters per gram per minute. A unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one hour.(NCI) A dose calculation unit equal to one milliliter of preparation per one kilogram of body mass. (NCI) Milliliters per kilogram per day.

mL/g/h mL/g/min Milliliter per Hour

C67411 C73758

mL/kg mL/kg/day

mL/kg mL/kg/day

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 497 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Milliliter per Kilogram per Hour Milliliter per Kilogram per Minute; uL/g/min; mL/min/kg; uL/min/g; mL/kg/min Milliliter per Square Meter Milliliter per Square Meter per Day Milliliter per Square Meter per Hour Milliliter per Square Meter per Minute Milliliters per Minute

NCI Code C73759

CDISC Submission Value mL/kg/h

CDISC Definition Milliliters per kilogram per hour.

NCI Preferred Term mL/kg/h

C73760

mL/kg/min

Milliliters per kilogram per minute.

mL/kg/min

C73761 C66977

mL/m2 mL/m2/day

A unit of measure expressed in milliliter(s) per square meter. A dose calculation unit expressed in milliliter(s) per square meter per period of time equal to twenty-four hours. (NCI) A dose calculation unit expressed in milliliter(s) per square meter per period of time equal to sixty minutes. (NCI) A dose calculation unit expressed in milliliter(s) per square meter per period of time equal to sixty seconds. (NCI) A metric unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one minute.(NCI) A metric unit of volumetric flow rate defined as the rate at which one milliliter of matter travels during the period of time equal to one minute per 1.73 meters squared of body surface area.

mL/m2 mL/m2/day

C73762

mL/m2/h

mL/m2/h

C73763

mL/m2/min

mL/m2/min

C64777

mL/min

Milliliter per Minute

C67412

mL/min/1.73m2

Milliliter per Minute per 1.73 m2 of Body Surface Area

C67318

mOsm

Milliosmole

A unit of osmotic pressure equal to one thousandth of an osmole or osmotic pressure of 0.001 molar solution of a substance that does not dissociate. (NCI) A unit of osmotic pressure equal to one thousandth of an osmole per kilogram substance. A SI derived unit of pressure equivalent to one thousandth of one pascal. (NCI) An arbitrary unit of substance concentration equal to the concentration at which one liter of mixture contains one thousandth of a unit of a substance.

mOsm

C67427 C73765 C67408

mOsm/kg mPa mU/L

Milliosmole per Kilogram Millipascal

mOsm/kg mPa Microunit per Milliliter

C67324 C28253

mV mg

Millivolt Milligram

A unit of electric potential and electromotive force equal to one thousandth of a volt.(NCI) The unit of mass equal to one thousandth of a gram or 1000 micrograms. One milligram equals approximately 0.015432 grain or 35.274 x 10E-6 ounce.(NCI)

Millivolt Milligram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 498 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym g/m3; Gram per Cubic Meter; mg/L; Microgram per Milliliter; Milligram per Liter; mcg/mL; ng/uL; ug/mL Milligram per Animal Milligram per Deciliter; mg%

NCI Code C64572

CDISC Submission Value mg/L

CDISC Definition A unit of mass concentration equal to the concentration of one gram of a substance per unit volume of the mixture equal to one cubic meter. The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which mass equal to one gram occupies the volume one cubic meter.(NCI) A unit of measure expressed in milligram(s) per animal. A unit of mass concentration defined as the concentration of one milligram of a substance in unit volume of the mixture equal to one cubic deciliter or 100 cubic centimeters. It is also a unit of mass density (volumic mass) defined as the density of substance which mass equal to one milligram occupies the volume one cubic deciliter or 100 cubic centimeters.(NCI) A unit of measure referring to the ratio between mass expressed in milligrams per day.(NCI) A dose calculation unit expressed in milligram(s) per gram per period of time equal to twenty-four hours. (NCI) A dose calculation unit expressed in milligram(s) per gram per period of time equal to sixty minutes. (NCI) A dose calculation unit expressed in milligram(s) per gram per period of time equal to sixty seconds. (NCI) A unit of mass flow rate equivalent to the rate at which one thousandth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) A unit of a mass fraction expressed as a number of milligrams of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) A dose calculation unit expressed in milligram(s) per kilogram per period of time equal to twenty-four hours. (NCI) A dose calculation unit equal to one thousandth of a gram of a preparation per one kilogram of body mass administered per unit of time equal to one hour.(NCI) A dose calculation unit equal to one thousandth of a gram of a preparation per one kilogram of body mass administered per unit of time equal to one minute.(NCI) A unit of area density equal to approximately 2.94935E-5 ounce per square yard. Also used as a dose calculation unit.(NCI) A dose calculation unit expressed in milligram(s) per square meter per period of time equal to twenty-four hours. (NCI)

NCI Preferred Term Microgram per Milliliter

C73738 C67015

mg/animal mg/dL

mg/animal Milligram per Deciliter

C67399 C74993

mg/day mg/g/day

Milligram per Day Milligram per Gram per Day Milligram per Gram per Hour Milligram per Gram per Minute Milligram per Hour

Milligram per 24 Hours mg/g/day

C73740 C73741 C66969

mg/g/h mg/g/min mg/h

mg/g/h mg/g/min Milligram per Hour

C67401

mg/kg

Milligram per Kilogram Milligram per Kilogram per Day Milligram per Kilogram per Hour Milligram per Kilogram per Minute Milligram per Square Meter Milligram per Square Meter per Day

Milligram per Kilogram

C66976

mg/kg/day

mg/kg/day

C71362

mg/kg/h

Milligram per Kilogram per Hour

C71207

mg/kg/min

Milligram per Kilogram per Minute

C67402

mg/m2

Milligram per Square Meter

C66974

mg/m2/day

mg/m2/day

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 499 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Milligram per Square Meter per Hour Milligram per Square Meter per Minute Milligram per Minute Minute Unit of Time Millikatal Millimeter Millimeter per Hour Square Millimeter

NCI Code C73743

CDISC Submission Value mg/m2/h

CDISC Definition A dose calculation unit expressed in milligram(s) per square meter per period of time equal to sixty minutes. (NCI) A dose calculation unit expressed in milligram(s) per square meter per period of time equal to sixty seconds. (NCI) Milligrams per minute. A unit measure of time equal to 60 seconds.(NCI) A unit of catalytic activity measurement equal to one thousandth of one katal (10E-3 katal).(NCI) A unit of measure equal to one thousandth of a meter. (NCI) A unit of both speed (scalar) and velocity (vector), defined as the distance of one millimeter travels per unit time equal to one hour.(NCI) A unit of area measurement equal to a square measuring one millimeter on each side. One square millimeter is equal to 10(E-2) square centimeter and 10(E-6) square meter.(NCI) A unit of pressure equal to 0.001316 atmosphere and equal to the pressure indicated by one millimeter rise of mercury in a barometer at the Earth's surface. (NCI) A rate of inflation or deflation of a manometric device based on the unit of pressure equal to 133,332 Pa or 1.316E10-3 standard atmosphere during period of time equal to one sixtieth of a minute. (NCI) A unit of amount of substance equal to 0.001 mole.(NCI) A unit of concentration (molarity unit) equal to one thousandth of a mole (10E-3 mole) of solute per one liter of solution.(NCI)

NCI Preferred Term mg/m2/h

C73744

mg/m2/min

mg/m2/min

C73742 C48154 C70507 C28251 C67419

mg/min min mkat mm mm/h

mg/min Minute Millikatal Millimeter Millimeter per Hour

C65104

mm2

Square Millimeter

C49670

mmHg

Millimeter of Mercury Millimeter of Mercury per Second Millimole Millimole per Liter; umol/mL; Micromole per Milliliter; mol/m3; Mole per Cubic Meter; mcmol/mL; mmol/L; nmol/uL Millimole per 24 Hours

Millimeter of Mercury

C73764

mmHg/sec

mmHg/sec

C48513 C64387

mmol mmol/L

Millimole Millimole per Liter

C67420

mmol/day

A unit of amount of substance flow rate equivalent to the rate at which one thousandth of a mole of substance travels or is delivered to a given object or space over a period of time equal to 24 hours.(NCI) A unit amount of substance content (molality unit) defined as one mole of solute per one kilogram of solvent.(NCI) A unit of amount of substance content (molality unit) defined as one thousandth of mole (10E-3 mole) of solute per one kilogram of solvent.(NCI)

Millimole per 24 Hours

C68740

mmol/g

Millimole per Gram Millimole per Kilogram

Mole per Kilogram

C68892

mmol/kg

Millimole per Kilogram

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 500 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Mole

NCI Code C42539

CDISC Submission Value mol

CDISC Definition A unit defined as the amount of substance that contains as many elementary units as there are atoms in 0.012 kg of carbon-12. When the mole is used, the elementary entities must be specified and may be atoms, molecules, ions, electrons, other particles, or specified groups of such particles.(NCI) A unit of concentration (molarity unit) equal to one mole of solute in one liter of solution.(NCI) A unit of amount of substance content (molality unit) defined as one mole of solute per one gram of solvent.(NCI) A unit of concentration (molarity unit) equal to one mole of solute in one milliliter of solution.(NCI) A unit of amount of substance content (molality unit) defined as one mole of solute per one milligram of solvent.(NCI) A unit of fraction expressed as the ratio of the amount of substance of solute in moles to the amount of substance of the mixture in moles.(NCI) A unit of time, which is equal to one thousandth of a second.(NCI) A unit of radioactivity equal to one billionth of Curie or 37 Becquerels, and corresponding to a radioactivity of 37 atomic disintegrations per second.(NCI) A unit of volume equal to one billionth of a liter (10E-9 liter).(NCI) A unit of mass equal to one billionth (10E-9) of a gram, or one millionth (10E-6) of a milligram.(NCI) A unit of mass concentration defined as the concentration of one nanogram of a substance per one liter of the mixture, or one picogram of a substance in unit volume of the mixture equal to one milliliter, or one microgram of a substance per one cubic meter of the mixture. The concept also refers to the metric unit of mass density (volumic mass) defined as the density of substance which mass equal to one nanogram occupies the volume one liter.(NCI) A unit of mass concentration defined as the concentration of one nanogram of a substance in unit volume of the mixture equal to one deciliter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one nanogram occupies the volume one deciliter.(NCI) A unit of catalytic activity measurement equal to one billionth of one katal (10E-9 katal).(NCI) A unit of catalytic activity concentration defined as the catalytic activity of the component equal to one billionth of one katal (10E-9 katal) in the unit volume of the system equal to one liter.(NCI) Mole

NCI Preferred Term

C48555 C68893

mol/L mol/g

Mole per Liter; mol/L; mmol/mL Mole per Gram

Mole per Liter Mole per Gram

C68891 C68894

mol/mL mol/mg

Mole per Milliliter Mole per Milligram Mole per Mole

Mole per Milliliter Mole per Milligram

C70455

mol/mol

Mole per Mole

C41140 C67352

msec nCi

Millisecond Nanocurie

Millisecond Nanocurie

C69188 C48516 C67327

nL ng ng/L

Nanoliter Nanogram ug/m3; Microgram per Cubic Meter; ng/L; pg/mL

Nanoliter Nanogram Nanogram per Liter

C67326

ng/dL

Nanogram per Deciliter

Nanogram per Deciliter

C70508 C70510

nkat nkat/L

Nanokatal Nanokatal per Liter

Nanokatal Nanokatal per Liter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 501 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Nanometer

NCI Code C67328

CDISC Submission Value nm

CDISC Definition A unit of length equal to one billionth of a meter (10E-9 meter). Nanometer is used as a unit for light wavelength measurement.(NCI) A unit of amount of substance equal to one billionth (10E-9) of a mole.(NCI) A unit of concentration (molarity unit) equal to one billionth of a mole (10E-9 mole) of solute in one liter of solution.(NCI) A unit of concentration (molarity unit) equal to one billionth of a mole (10E-9 mole) of solute in one milliliter of solution to be administered per minute of time. A unit of time equal to one billionth of a second. (NCI) A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in Siemens. (NCI) A unit of osmotic pressure equal to that of an ideal solution of a nondissociating substance that has a concentration of one mole of solute per liter of solution.(NCI) A unit of mass, the avoirdupois ounce is equal to 1/16 pound, or 28.3495 grams, or 0.911 457 troy ounce.(NCI) A measure of the acidity or alkalinity of a fluid on a scale of 0 to 14.(NCI) A unit of volume equal to one trillionth of a liter (10E-12 liter). (NCI) The number of occurrences of something within a minute of time.(NCI) The number of occurrences of something within a second of time.(NCI) A unit of mass equal to one trillionth of a gram (10E-12 gram).(NCI) Picograms per deciliter. A unit of catalytic activity measurement equal to trillionth of one katal (10E-12 katal).(NCI) A unit of length equal to one trillionth of a meter (10E-12 meter).(NCI) A unit of amount of substance equal to a trillionth (10E-12) of a mole.(NCI)

NCI Preferred Term Nanometer

C48517 C67432

nmol nmol/L

Nanomole Nanomole per Liter Nanomole per Milliliter per Minute Nanosecond Ohm

Nanomole Nanomole per Liter

C92613

nmol/mL/min

Nanomole per Minute per Milliliter

C73767 C42554

nsec ohm

nsec Ohm

C67330

osm

Osmole

Osmole

C48519

oz

Ounce

Ounce

C45997 C69189 C66967 C66965 C64551 C67331 C70509 C69148 C65045

pH pL per min per sec pg pg/dL pkat pm pmol

pH Picoliter Per Minute Per Second Picogram Picogram per Deciliter Picokatal Picometer Picomole

pH pL Per Minute Per Second Picogram pg/dL Picokatal Picometer Picomole

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 502 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Picomole per Liter; fmol/mL; Femtomole per Milliliter Part per Billion Part per Million Part per Thousand Parts per Trillion Picosecond Pounds per Square Inch Revolution per Minute m3; Standard Cubic Meter

NCI Code C67434

CDISC Submission Value pmol/L

CDISC Definition A unit of concentration (molarity unit) equal to one trillionth of a mole (10E-12 mole) in one liter of solution.(NCI) A unit of measure referring to one entity counted per one billion entities.(NCI) A unit of measurement referring to one entity counted per one million entities.(NCI) A unit of proportion equal to 10E-3.(NCI) A unit of measure referring to one entity counted per one trillion entities.(NCI) A unit of time equal to one trillionth of a second. (NCI) A unit of pressure equivalent to 6.894757 kilopascals, or 703.0696 kilograms per square meter, or 51.71507 millimeters of mercury.(NCI) A unit of frequency equal to one revolution per unit of time equal to one minute.(NCI) A unit used in physical chemistry to express the amount of substance of an ideal gas in one cubic meter at standard conditions: temperature 273.15 K and pressure of one atmosphere (101.325 kilopascals).(NCI) The second is a unit of time with a duration of 919 263 177 0 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. According to the convention, 60 seconds constitute one minute; 3,600 seconds constitute one hour. Abbreviation Sec. is acceptable in non-scientific usage only.(NCI) A unit of volume used in pharmacy equal to 5 milliliters.(NCI) An arbitrary unit of tuberculin dosage defined by comparison of clinical response with a preparation of the purified protein derivative standardized for use in humans for tuberculin skin test reaction.(NCI) A unit of biologic activity of tuberculin expressed as a number of arbitrary units of tuberculin in one milliliter of preparation.(NCI) A unit of radioactivity equal to one millionth of a Curie or 37 kilobecquerels, and corresponding to a radioactivity of 37 000 atomic disintegrations per second.(NCI) A unit of volumetric radioactivity concentration defined as a concentration of a radionuclide with an activity equal to one millionth of a Curie per unit volume equal to one liter.(NCI)

NCI Preferred Term Picomole per Liter

C70565 C48523 C69112 C70566 C73768 C67334

ppb ppm ppth pptr psec psi

Per Billion Part Per Million Part per Thousand Per Trillion psec Pound per Square Inch

C70469 C68858

rpm scm

Revolution per Minute m3

C42535

sec

Second

Second

C48544 C65132

tsp tuberculin unit

Teaspoon Dosing Unit Tuberculin Unit

Teaspoon Dosing Unit Tuberculin Unit

C70506

tuberculin unit/mL

Tuberculin Unit per Milliliter Microcurie; mcCi

Tuberculin Unit per Milliliter

C48507

uCi

Microcurie

C71173

uCi/L

Microcurie per Liter; mcCi/L

Microcurie per Liter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 503 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Microcurie per Kilogram; mcCi/kg Microequivalent Micro-Internatio nal Unit per milliliter; mIU/L; mcIU/mL; uIU/mL mcL; Microliter; mm3 Microliter per Milliliter; mcL/mL Microosmole

NCI Code C70571

CDISC Submission Value uCi/kg

CDISC Definition A unit of specific radioactivity (massic activity) equal to activity of one microcurie of the sample with total mass of one kilogram.(NCI) A unit of relative amount of a substance equal to one millionth of an equivalent weight.(NCI) Microinternational units per milliliter.

NCI Preferred Term Microcurie per Kilogram

C73726 C67405

uEq uIU/mL

uEq uIU/mL

C48153 C69175

uL uL/mL

A unit of volume accepted for use with the SI and equal to one millionth of a liter (10E-6 liter).(NCI) A unit of volume fraction expressed as a number of microliters of the constituent per the volume of the system represented in milliliters.(NCI) A unit of osmotic pressure equal to one millionth of an osmole or the osmotic pressure of a 10E-6 molar solution of a substance that does not dissociate. (NCI) A unit of an electric potential and electromotive force equal to one millionth of a volt.(NCI) The unit of mass equal to one millionth of a gram or one thousandth of a milligram.(NCI) A unit of mass concentration defined as the concentration of one microgram of a substance per unit volume of the mixture equal to one liter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one microgram occupies the volume one liter.(NCI) A unit of measure expressed in microgram(s) per animal. A unit of mass concentration defined as the concentration of one microgram of a substance per unit volume of the mixture equal to one deciliter. The concept also refers to the unit of mass density (volumic mass) defined as the density of substance which mass equal to one microgram occupies the volume one deciliter. (NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to twenty four hours. Microgram per day is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to twenty four hours.(NCI) A dose calculation unit expressed in microgram(s) per gram per period of time equal to twenty-four hours. (NCI) A dose calculation unit expressed in microgram(s) per gram per period of time equal to sixty minutes. (NCI)

uL Microliter per Milliliter

C73736

uOsM

uOsM

C71175 C48152 C67306

uV ug ug/L

Microvolt; mcV Microgram; mcg mg/m3; Microgram per Liter; Milligram per Cubic Meter; Nanogram per Milliliter; ug/L; ng/mL; mcg/L Microgram per Animal Microgram per Deciliter

Microvolt Microgram Microgram per Liter

C73728 C67305

ug/animal ug/dL

ug/animal ug/dL

C71205

ug/day

Microgram per Day; mcg/day

Microgram per Day

C74921

ug/g/day

Microgram per Gram per Day Microgram per Gram per Hour

ug/g/day

C74922

ug/g/h

ug/g/h

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 504 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Microgram per Gram per Minute Micrograms per Hour; mcg/h

NCI Code C74923 C67394

CDISC Submission Value ug/g/min ug/h

CDISC Definition A dose calculation unit expressed in microgram(s) per gram per period of time equal to sixty seconds. (NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to one hour.(NCI) A unit of a mass fraction expressed as a number of micrograms of substance per kilogram of mixture. The unit is also used as a dose calculation unit.(NCI) A dose calculation unit expressed in microgram(s) per kilogram per period of time equal to twenty-four hours. (NCI) A dose calculation unit expressed in microgram(s) per kilogram per period of time equal to sixty minutes. (NCI) A dose calculation unit equal to one millionth of a gram of a preparation per one kilogram of body mass administered per unit of time equal to one minute.(NCI)

NCI Preferred Term ug/g/min Microgram per Hour

C67396

ug/kg

mcg/kg; Microgram per Kilogram; ng/g; ug/kg Microgram per Kilogram per Day Microgram per Kilogram per Hour Microgram per Kilogram per Minute; Gamma per Kilogram per Minute; gamma/kg/min; mcg/kg/min Microgram per Square Meter Microgram per Square Meter per Day Microgram per Square Meter per Hour Microgram per Square Meter per Minute Microgram per Milliliter per Hour Micrograms per Minute; mcg/min

Microgram per Kilogram

C73729

ug/kg/day

ug/kg/day

C73730

ug/kg/h

ug/kg/h

C71210

ug/kg/min

Microgram per Kilogram per Minute

C67312 C73787

ug/m2 ug/m2/day

A dose calculation unit expressed in microgram(s) per square meter. A dose calculation unit expressed in microgram(s) per square meter per period of time equal to twenty-four hours. (NCI) A dose calculation unit expressed in microgram(s) per square meter per period of time equal to sixty minutes. (NCI) A dose calculation unit expressed in microgram(s) per square meter per period of time equal to sixty seconds. (NCI) A dose calculation unit expressed in microgram(s) per milliliter of solution per period of time equal to sixty minutes. (NCI) A unit of mass flow rate equivalent to the rate at which one millionth of a gram of matter travels to a given object or space over a period of time equal to one minute. Microgram per minute is also a dose administration rate unit equal to the rate at which one millionth of a gram of a product is administered per unit of time equal to one minute.(NCI) A unit of catalytic activity measurement equal to one millionth of katal (10E-6 katal).(NCI) Unit of catalytic activity concentration defined as activity equal to one millionth of katal per one liter of the system volume.(NCI)

ug/m2 ug/m2/day

C73727

ug/m2/h

ug/m2/h

C73733

ug/m2/min

ug/m2/min

C75905

ug/mL/h

ug/mL/h

C71211

ug/min

Microgram per Minute

C70562 C67397

ukat ukat/L

Microkatal; mckat Microkatal per Liter; mckat/L

Microkatal Microkatal per Liter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 505 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C71620 - UNIT - Unit Codelist extensible: Yes
CDISC Synonym Micron; mcm MicroSquare Meter Cubic Micrometer Micromole; mcmol Micromole per Liter Micromoles per Day; mcmol/day

NCI Code C48510 C73770 C67565 C48509 C48508

CDISC Submission Value um um2 um3 umol umol/L

CDISC Definition A unit of length in metric system equal to 10E-6 meter, or micrometer.(NCI) A SI unit of area measurement equal to a square whose sides are one micrometer long. (NCI) A unit of volume equal to 10E-18 liter or one cubic micrometer. A unit of amount of substance equal to one millionth (10E-6) of a mole.(NCI) A unit of concentration (molarity unit) equal to one one-millionth of a mole (10E-6 mole) of solute per one liter of solution. (NCI) A unit of amount of substance flow rate equivalent to the rate at which one millionth of a mole of substance travels to a given object or space over a period of time equal to 24 hours.(NCI) A unit of concentration (molarity unit) equal to one millionth of a mole (10E-6 mole) per milligram of a substance per period of time equal to sixty seconds. (NCI) A unit of time equal to one millionth of a second. (NCI) A unit of length equal to 3 feet, or 36 inches, or 0.9144 meter.(NCI) Micron

NCI Preferred Term

Square Micrometer Attoliter Micromole umol/L

C67406

umol/day

Micromole per 24 Hours

C73735

umol/mg/min

Micromole per Milligram per Minute Microsecond Yard

umol/mg/min

C69149 C48553

usec yd

usec Yard

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 506 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66770 - VSRESU - Units for Vital Signs Results Codelist extensible: Yes
CDISC Synonym Percentage Beats per Minute Breaths per Minute Degree Celsius

NCI Code C25613 C49673 C49674 C42559

CDISC Submission Value % BEATS/MIN BREATHS/MIN C

CDISC Definition A fraction or ratio with 100 understood as the denominator. (NCI) The number of heartbeats measured per minute time. (NCI) The number of breaths (inhalation and exhalation) taken per minute time. (NCI) A unit of temperature of the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin. (NCI) The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a Kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI) A traditional unit of length equal to 2.54 centimeters. (NCI) A traditional unit of mass. By international agreement, one avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI) A basic unit of length in the former CGS version of metric system, equal to one hundredth of a meter or approximately 0.393 700 787 inch. (NCI) A metric unit of mass equal to one one thousandth of a kilogram. (NCI) The basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in terms of a material object, and also the only one with a prefix [kilo] already in place. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds. (NCI) The SI derived unit of spread rate of a substance by mass, used also as a measure of area density. (NCI) The SI unit of area measurement equal to a square whose sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 ares; 1.196 square yards; 10.76 square feet; 1550 square inches. (NCI)

NCI Preferred Term Percentage Beats per Minute Breaths per Minute Degree Celsius

C44277

Degree Fahrenheit

Degree Fahrenheit

C48500 C48531

IN LB

Inch Pound

Inch Pound

C49668

cm

Centimeter

Centimeter

C48155 C28252

g kg

Gram Kilogram

Gram Kilogram

C49671 C42569

kg/m2 m2

Kilogram Per Square Meter Square Meter

Kilogram Per Square Meter Square Meter

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 507 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66770 - VSRESU - Units for Vital Signs Results Codelist extensible: Yes
CDISC Synonym Millimeter of Mercury Ohm

NCI Code C49670

CDISC Submission Value mmHg

CDISC Definition A unit of pressure equal to 0.001316 atmosphere and equal to the pressure indicated by one millimeter rise of mercury in a barometer at the Earth's surface. (NCI) A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one Ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in Siemens. (NCI)

NCI Preferred Term Millimeter of Mercury

C42554

ohm

Ohm

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 508 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67153 - VSTEST - Vital Signs Test Name Codelist extensible: Yes
CDISC Synonym Adipose Tissue

NCI Code C12472

CDISC Submission Value Adipose Tissue

CDISC Definition A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. The categorization of a person's body frame into small, medium and large based on the measurement of wrist circumference or the breadth of the elbow. (NCI) A general indicator of the body fat an individual is carrying based upon the ratio of weight to height. (NCI) A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area (BSA) can be calculated by mathematical formula or from a chart that relates height to weight. BSA is often an important factor in dosing. (NCI) The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. (NCI) The distance around an individual's forearm. A circumferential measurement of the head at the widest point, which is traditionally above the eyebrows. The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI) The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension. (NCI) The distance around an individual's pelvic area or hips. A measurement of the length of the lower leg from the top of the knee to the bottom of the heel. This measurement may be taken with a knemometer or calipers. (NCI) The weight of all organs and tissue in an individual less the weight of the individual's body fat. The mean pressure of the blood within the arterial circulation. The arterial pressure may be directly measured by insertion of an intra-arterial catheter connected to a transducer. The mean arterial pressure (MAP) can be calculated by subsequent analysis of the waveform. MAP can be approximated without an invasive procedure using the following formula: diastolic pressure plus 1/3 of the pulse pressure, where pulse pressure is systolic pressure - diastolic pressure. (NCI) The change in systolic to diastolic pressure which produces a pulse.

NCI Preferred Term Adipose Tissue

C49680

Body Frame Size

Body Frame Size

Body Frame Size

C16358

Body Mass Index

Body Mass Index

Body Mass Index

C25157

Body Surface Area

Body Surface Area

Body Surface Area

C25299

Diastolic Blood Pressure

Diastolic Blood Pressure Forearm Circumference Head Circumference Heart Rate Height

Diastolic Blood Pressure

C100946 C81255

Forearm Circumference Head Circumference

Forearm Circumference Head Circumference

C49677 C25347

Heart Rate Height

Heart Rate Height

C100947 C84372

Hip Circumference Knee to Heel Length

Hip Circumference Knee to Heel Length; Lower Leg Length Lean Body Mass Mean Arterial Pressure

Hip Circumference Knee to Heel Length Measurement

C71258 C49679

Lean Body Mass Mean Arterial Pressure

Lean Body Mass Mean Arterial Pressure

C100945

Pulse Pressure

Pulse Pressure

Pulse Pressure

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 509 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C67153 - VSTEST - Vital Signs Test Name Codelist extensible: Yes
CDISC Synonym Pulse Rate

NCI Code C49676

CDISC Submission Value Pulse Rate

CDISC Definition The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. (NCI) The rate of breathing (inhalation and exhalation) measured within in a unit time, usually expressed as breaths per minute. (NCI) A standard measure of visceral obesity, or abdominal fat, which is measured from the patient's back to upper abdomen between the bottom of the rib cage and the top of the pelvic area. This measurement may be taken with the patient standing or in the supine position. (NCI) A measurement of the thickness of a pinch of skin situated below or on the underside of the scapula. (NCI) The blood pressure during the contraction of the left ventricle of the heart. The property of a body or region of space that determines whether or not there will be a net flow of heat into it or out of it from a neighboring body or region and in which direction (if any) the heat will flow, perceptible by living organism as a somatic sensation of cold or heat. It is a measure of the average translational kinetic energy associated with the disordered microscopic motion of atoms and molecules. Temperature is measured in one of the three standard temperature scales: Celsius, Kelvin, and Fahrenheit. (NCI) A measurement of the thickness of a pinch of skin on the triceps. (NCI) The distance around an individual's midsection or waist. The vertical force exerted by a mass as a result of gravity. (NCI)

NCI Preferred Term Pulse Rate

C49678

Respiratory Rate

Respiratory Rate

Respiratory Rate

C87054

Sagittal Abdominal Diameter

Sagittal Abdominal Diameter

Sagittal Abdominal Diameter

C98785

Subscapular Skinfold Thickness Systolic Blood Pressure Temperature

Subscapular Skinfold Thickness Systolic Blood Pressure Temperature

Subscapular Skinfold Thickness

C25298 C25206

Systolic Blood Pressure Temperature

C98793 C100948 C25208

Triceps Skinfold Thickness Waist Circumference Weight

Triceps Skinfold Thickness Waist Circumference Weight

Triceps Skinfold Thickness Waist Circumference Weight

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 510 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66741 - VSTESTCD - Vital Signs Test Code Codelist extensible: Yes
CDISC Synonym Body Mass Index

NCI Code C16358

CDISC Submission Value BMI

CDISC Definition A general indicator of the body fat an individual is carrying based upon the ratio of weight to height. (NCI) A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area (BSA) can be calculated by mathematical formula or from a chart that relates height to weight. BSA is often an important factor in dosing. (NCI) The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. (NCI) The distance around an individual's forearm. The categorization of a person's body frame into small, medium and large based on the measurement of wrist circumference or the breadth of the elbow. (NCI) A circumferential measurement of the head at the widest point, which is traditionally above the eyebrows. The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension. (NCI) The distance around an individual's pelvic area or hips. The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI) A measurement of the length of the lower leg from the top of the knee to the bottom of the heel. This measurement may be taken with a knemometer or calipers. (NCI) The weight of all organs and tissue in an individual less the weight of the individual's body fat. The mean pressure of the blood within the arterial circulation. The arterial pressure may be directly measured by insertion of an intra-arterial catheter connected to a transducer. The mean arterial pressure (MAP) can be calculated by subsequent analysis of the waveform. MAP can be approximated without an invasive procedure using the following formula: diastolic pressure plus 1/3 of the pulse pressure, where pulse pressure is systolic pressure - diastolic pressure. (NCI) The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. (NCI)

NCI Preferred Term Body Mass Index

C12472

BODYFAT

Adipose Tissue

Adipose Tissue

C25157

BSA

Body Surface Area

Body Surface Area

C25299

DIABP

Diastolic Blood Pressure Forearm Circumference Body Frame Size

Diastolic Blood Pressure

C100946 C49680

FARMCIR FRMSIZE

Forearm Circumference Body Frame Size

C81255

HDCIRC

Head Circumference Height

Head Circumference

C25347

HEIGHT

Height

C100947 C49677 C84372

HIPCIR HR KNEEHEEL

Hip Circumference Heart Rate Knee to Heel Length; Lower Leg Length Lean Body Mass Mean Arterial Pressure

Hip Circumference Heart Rate Knee to Heel Length Measurement

C71258 C49679

LBM MAP

Lean Body Mass Mean Arterial Pressure

C49676

PULSE

Pulse Rate

Pulse Rate

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 511 of 512 -

CDISC SDTM Controlled Terminology, 2012-06-29


C66741 - VSTESTCD - Vital Signs Test Code Codelist extensible: Yes
CDISC Synonym Pulse Pressure Respiratory Rate

NCI Code C100945 C49678

CDISC Submission Value PULSEPR RESP

CDISC Definition The change in systolic to diastolic pressure which produces a pulse. The rate of breathing (inhalation and exhalation) measured within in a unit time, usually expressed as breaths per minute. (NCI) A standard measure of visceral obesity, or abdominal fat, which is measured from the patient's back to upper abdomen between the bottom of the rib cage and the top of the pelvic area. This measurement may be taken with the patient standing or in the supine position. (NCI) A measurement of the thickness of a pinch of skin situated below or on the underside of the scapula. (NCI) The blood pressure during the contraction of the left ventricle of the heart. The property of a body or region of space that determines whether or not there will be a net flow of heat into it or out of it from a neighboring body or region and in which direction (if any) the heat will flow, perceptible by living organism as a somatic sensation of cold or heat. It is a measure of the average translational kinetic energy associated with the disordered microscopic motion of atoms and molecules. Temperature is measured in one of the three standard temperature scales: Celsius, Kelvin, and Fahrenheit. (NCI) A measurement of the thickness of a pinch of skin on the triceps. (NCI) The vertical force exerted by a mass as a result of gravity. (NCI) The distance around an individual's midsection or waist.

NCI Preferred Term Pulse Pressure Respiratory Rate

C87054

SAD

Sagittal Abdominal Diameter

Sagittal Abdominal Diameter

C98785

SSSKNF

Subscapular Skinfold Thickness Systolic Blood Pressure Temperature

Subscapular Skinfold Thickness

C25298 C25206

SYSBP TEMP

Systolic Blood Pressure Temperature

C98793 C25208 C100948

TRSKNF WEIGHT WSTCIR

Triceps Skinfold Thickness Weight Waist Circumference

Triceps Skinfold Thickness Weight Waist Circumference

Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 512 of 512 -

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