Study Code: Randomisation no: Subject initials:

CASE REPORT FORM

STUDY TITLE

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and

Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-653 in Healthy
Subjects

Study reference number TAK-653-1001

CLINICAL TRIAL SITE/UNIT:

PRINCIPAL INVESTIGATOR:

Subject Initials:

Subject Randomisation Number:

I am confident that the information supplied in this case record form is complete and
accurate data. I confirm that the study was conducted in accordance with the protocol
and any protocol amendments and that written informed consent was obtained prior to
the study.

Investigator’s Signature:

Date of signature:

D d m m m y y y y

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Health Network. Please reference The Global Health Network
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Study Code: Randomisation no: Subject initials:

Visit 0 screening (-28 to -2)

Date: _______________
DD MMM YYYY

DEMOGRAPHIC DATA

Age (yrs): Sex: Female Male


Height (m):


Weight (Kg):


Body Mass Index (BMI = Wt (kg)/H2 (M):

INFORMED CONSENT
Please note: written informed consent must be given before any study specific procedures take
place or any current therapy is discontinued for the purposes of participation in this study.
Has the subject freely given written informed consent? Yes No

VISIT 1 (SCREENING)

PREVIOUS MEDICAL HISTORY

Is there any relevant medical history in the following systems?
Code System *Yes No Code System *Yes No

1 Cardiovascular 9 Neoplasia

2 Respiratory 10 Neurological

3 Hepato-biliary 11 Psychological

4 Gastro-intestinal 12 Immunological

5 Genito-urinary 13 Dermatological

6 Endocrine 14 Allergies

7 Haematological 15 Eyes, ear, nose, throat

8 Musculo-skeletal 00 Other

Version: DRAFT 1
Study Code: Randomisation no: Subject initials:

*If YES for any of the above, enter the code for each condition in the boxes below, give further
details (including dates) and state if the condition is currently or potentially active. If giving
details of surgery please specify the underlying cause. Use a separate line for each condition.
Currently Active?

Code Details (including dates) Yes No

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If ABNORMAL enter the code for each condition in the boxes below and give brief details.
Please use a separate line for each condition.

Code Details

Version: DRAFT 1
 Study Code: Randomisation no: Subject initials:

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

CONCOMITANT MEDICATIONS

Total

Continuing
Start Date Stop Date
Medication Daily Units Reason
(MM/DD/YYYY) (MM/DD/YYYY)
Dose

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

Version: DRAFT 1
Study Code: Randomisation no: Subject initials:

LABORATORY ANALYSIS Initials

Taken by
Blood for haematology and biochemistry

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

No
Does any result contradict study entry? *Yes
Initials:

*If YES, subject must not continue. Please complete off study page.

Page 5

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materials in exchange. www.theglobalhealthnetwork.org.
 Study Code: Randomisation no: Subject initials:

Adverse Events

Has the patient experienced any Adverse Events since signing the Informed Consent? Yes,

Outcome Action taken with

Study Drug
1=Recovered
Start Date Stop Date 1=None
2=Recovered Severity
dd/mmm/yyyy dd/mmm/yyyy
with sequelae Plausible 2=Dose Reduction
AE Adverse Event (diagnosis (if known) or 1=Mild
and Time and Time relationship Temporarily
no. signs/symptoms) 3=Continuing 2=Moderate
(24 hour (24 hour
to Study Drug 3=Dose Reduced
4=Patient Died 3=Severe
clock) clock) 4=Discontinued
5=Change in AE Temporarily
6=unknown 5=Discontinued

/ / / / Yes

: : No

/ / / / Yes

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

: : No

/ / / / Yes

: : No

VISIT 1 (SCREENING)

LABORATORY ANALYSIS
Taken by
Blood for haematology and biochemistry

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS

**Description
:

Does any result contradict study entry? *Yes

Initials:

*If YES, subject must not continue. Please complete off study page.

ECG
Is the ECG: Normal Abnormal **
**Description: ____________________________________________________________
Retain signed and dated trace in the plastic sleeve at back of CRF

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

Yes

No*

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Study Code: Randomisation no: Subject initials:

Inclusion Criteria
1 Is the subject a healthy male aged between 18 and 60 years?

2 Has the subject willingly given written informed consent?

*If any inclusion criteria are ticked no then the patient is not eligible for the study.

Exclusion Criteria Yes* No

1

* If any exclusion criteria are ticked yes then the patient is not eligible for the study.

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

V
Date: _______________
DD MMM YYYY

INFORMED CONSENT
Please note: written informed consent must be given before any study specific procedures take
place or any current therapy is discontinued for the purposes of participation in this study.
Has the subject freely given written informed consent? Yes No

DEMOGRAPHIC DATA

Age (yrs): Sex: Female Male


Height (m):


Weight (Kg):


Body Mass Index (BMI = Wt (kg)/H2 (M):

SMOKING HABITS

Does the subject smoke or use tobacco products? *Yes No

* How many cigarettes per day?

Other, specify
--------------------------------------------------------------

ALCOHOL CONSUMPTION

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

Does the subject consume alcohol? Yes No

If yes, how many units per week?

MEDICATIONS TAKEN
This template has been freely provided by The Global Health
Network. Please reference The Global Health Network when
Isyou
theuse
subject currently
it, and share your or
ownpreviously
materials intaking any medication including OTC, vitamins and/or
exchange.
www.theglobalhealthnetwork.org.
supplements? Yes No
*Record all medication on Concomitant Medications page
VISIT 1 (SCREENING)

PREVIOUS MEDICAL HISTORY

Is there any relevant medical history in the following systems?
Code System *Yes No Code System *Yes No

1 Cardiovascular 9 Neoplasia

2 Respiratory 10 Neurological

3 Hepato-biliary 11 Psychological

4 Gastro-intestinal 12 Immunological

5 Genito-urinary 13 Dermatological

6 Endocrine 14 Allergies

7 Haematological 15 Eyes, ear, nose, throat

8 Musculo-skeletal 00 Other

*If YES for any of the above, enter the code for each condition in the boxes below, give
further details (including dates) and state if the condition is currently or potentially
active. If giving details of surgery please specify the underlying cause. Use a separate
line for each condition.
Currently Active?

Code Details (including dates) Yes No

Page 12

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reference The Global Health Network when you use it, and share your own
materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

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reference The Global Health Network when you use it, and share your own
materials in exchange. www.theglobalhealthnetwork.org.
 Study Code: Randomisation no: Subject initials:

VISIT 1 (SCREENING)

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If ABNORMAL enter the code for each condition in the boxes below and give brief details.
Please use a separate line for each condition.

Code Details

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

ECG
Is the ECG: Normal Abnormal **
**Description: ____________________________________________________________
Retain signed and dated trace in the plastic sleeve at back of CRF

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reference The Global Health Network when you use it, and share your own
materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

VISIT 1 (SCREENING)

LABORATORY ANALYSIS Initials

Taken by
Blood for haematology and biochemistry

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

No
Does any result contradict study entry? *Yes
Initials:

*If YES, subject must not continue. Please complete off study page.

Add Study Specific Data, as relevant for the particular study

Page 15

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reference The Global Health Network when you use it, and share your own
materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

VISIT 1 (SCREENING)

End of Visit Checklist: to be completed by Investigator

Yes No

1 Does the subject satisfy the inclusion and exclusion criteria to date?

2 Have all screening procedures been completed?

3 Has the concomitant medication page been completed?

4 Is the subject willing to proceed?

Investigator

Yes No

Is the subject to continue?

Has medication been collected from Pharmacy?

Have the dosing instructions been explained to the patient?

Signature: Date:
d d m m m y y y y

If ‘Yes’ please:
Complete details of next visit and any other needed instructions on the instruction card.
Give the subject the instruction card

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

VISIT 2 (WEEK 1) Date:______________

DD MMM YYYY

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If any changes from baseline, complete adverse event page.

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

LABORATORY ANALYSIS Initials

Blood for haematology and biochemistry Taken by

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

No
Does any result contradict continuation in the study? *Yes
*If YES, subject must not continue. Please complete off study page.

Add Study Specific Data, as relevant for the particular study

VISIT 3 (WEEK 26) Date:______________
DD MMM YYYY
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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If any changes from baseline, complete adverse event page.

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

LABORATORY ANALYSIS Initials

Blood for haematology and biochemistry Taken by

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

No
Does any result contradict continuation in the study? *Yes
*If YES, subject must not continue. Please complete off study page.

Add Study Specific Data, as relevant for the particular study

VISIT 4 (WEEK 52) Date:______________
DD MMM YYYY

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If any changes from baseline, complete adverse event page.

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

LABORATORY ANALYSIS Initials

Blood for haematology and biochemistry Taken by

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Haematology

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

No
Does any result contradict continuation in the study? *Yes
*If YES, subject must not continue. Please complete off study page.

Add Study Specific Data, as relevant for the particular study

VISIT 5 (WEEK 56) Date:______________

DD MMM YYYY

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

PHYSICAL EXAMINATION (to be carried out by medical staff only)

Code System *Abnormal Normal

1 General Appearance

2 Heart

3 Lungs

4 Abdomen

5 Extremities

* If any changes from baseline, complete adverse event page.

VITAL SIGNS
Pulse rate Bpm

Blood pressure (seated)  mmHg

LABORATORY ANALYSIS Initials

Blood for U+Es Taken by

 Repeat Sample Required? Date Taken (dd mmm yyyy)

Clinical Chemistry

Please insert a copy of all results in the plastic sleeve at the back of the CRF.

Are all final results: Normal Abnormal NCS **Abnormal CS

**Description
:

Has renal function remained stable? Yes *No

*If No, record on adverse event page.

Add Study Specific Data, as relevant for the particular study

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materials in exchange. www.theglobalhealthnetwork.org.
Study Code: Randomisation no: Subject initials:

CONCOMITANT MEDICATIONS

Total

Continuing
Start Date Stop Date
Medication Daily Units Reason
(MM/DD/YYYY) (MM/DD/YYYY)
Dose

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

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Study Code: Randomisation no: Subject initials:

___ ___ / ___ ___ / ___ ___ ___ ___ ___ ___ / ___ ___ / ___ ___ ___ ___

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materials in exchange. www.theglobalhealthnetwork.org.
 Study Code: Randomisation no: Subject initials:

Adverse Events

Has the patient experienced any Adverse Events since signing the Informed Consent? Yes, specify below No

Outcome Action taken with

Study Drug
1=Recovered
Start Date Stop Date 1=None If SAE does it
2=Recovered Severity
dd/mmm/yyyy dd/mmm/yyyy
with sequelae Plausible 2=Dose Reduction require
AE Adverse Event (diagnosis (if known) or 1=Mild Withdrawn Serious AE
and Time and Time relationship Temporarily immediate
no. signs/symptoms) 3=Continuing 2=Moderate due to AE? (SAE)?
(24 hour (24 hour
to Study Drug 3=Dose Reduced reporting?
4=Patient Died 3=Severe (see Protocol)?
clock) clock) 4=Discontinued
5=Change in AE Temporarily
6=unknown 5=Discontinued

/ / / / Yes Yes Yes Yes

: : No No No No

/ / / / Yes Yes Yes Yes

: : No No No No

/ / / / Yes Yes Yes Yes

: : No No No No

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Study Code: Randomisation no: Subject initials:

OFF STUDY FORM

Date Off Study: ___ ___ / ___ ___ / ___ ___ ___ ___
(MM/DD/YYYY)

Date Last Study Medication Taken: ___ ___ / ___ ___ / ___ ___ ___ ___

(MM/DD/YYYY)

Reason Off Study (Please mark only the primary reason. Reasons other than Completed Study require
explanation next to the response)
Completed study
AE/SAE (complete AE CRF & SAE form, if applicable) _________________________________________________________________
Lost to follow-up _______________________________________________________________________________________________

Non-compliant participant _____________________________________________________________________________________

Concomitant medication ______________________________________________________________________________________

Medical contraindication ______________________________________________________________________________________
Withdraw consent _____________________________________________________________________________________________

Death (complete SAE form) ______________________________________________________________________

Other __________________________________________________________________________________________________________

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