125742 S1 M5 CRF c4591001 1214 12141039

Document text

Page 1 of 492
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821439
Page 2 of 492
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/6/2020
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821440
Page 3 of 492
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12141039]
2.Birth Date: /1982
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821441
Page 4 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821442
Page 5 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821443
Page 6 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821444
Page 7 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821445
Page 8 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821446
Page 9 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
2.Weight: [84.0]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821447
Page 10 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/6/2020
2.Randomization Number: [115789]
3.Randomization Group: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821448
Page 11 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZD5B]
5.bSample ID [BPZD5C]
5.cSample ID [BSHCXN]
5.dSample ID [BSHCXP]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821449
Page 12 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZD4P]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821450
Page 13 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/6/2020 11:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821451
Page 14 of 492
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821452
Page 15 of 492
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/27/2020
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821453
Page 16 of 492
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821454
Page 17 of 492
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Nov/12/2020
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821455
Page 18 of 492
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821456
Page 19 of 492
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZD7S]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821457
Page 20 of 492
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/27/2020 12:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821458
Page 21 of 492
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821459
Page 22 of 492
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821460
Page 23 of 492
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821461
Page 24 of 492
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSHD1J]
5.bSample ID [BSHD1K]
5.cSample ID [BPZDC2]
5.dSample ID [BPZDC3]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821462
Page 25 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821463
Page 26 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/8/2021
2.Date of First Symptom Started: Jan/5/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/9/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821464
Page 27 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821465
Page 28 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821466
Page 29 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821467
Page 30 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[sample was collected as swab pfe] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821468
Page 31 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5CW1]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821469
Page 32 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821470
Page 33 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821471
Page 34 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821472
Page 35 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821473
Page 36 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821474
Page 37 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821475
Page 38 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821476
Page 39 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821477
Page 40 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821478
Page 41 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821479
Page 42 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821480
Page 43 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821481
Page 44 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821482
Page 45 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821483
Page 46 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821484
Page 47 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821485
Page 48 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821486
Page 49 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821487
Page 50 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821488
Page 51 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821489
Page 52 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821490
Page 53 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821491
Page 54 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821492
Page 55 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821493
Page 56 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821494
Page 57 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821495
Page 58 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821496
Page 59 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821497
Page 60 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821498
Page 61 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5CXW]
5.bSample ID [BR5CXX]
5.cSample ID [BSHD05]
5.dSample ID [BSHD06]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821499
Page 62 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821500
Page 63 of 492
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821501
Page 64 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  diarrhea  Nov/26/2020 1
7:00 NO
End Date Time:
Nov/27/2020 11:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  lymphadenomegaly in the right
submandibular Jan/6/2021 UN
K:UNK NO
End Date Time:
Jan/15/2021 UNK:UN
K
 Repeating
Pages
 3.ADVERSE E
VENT 3  pain at the injection site  Feb/8/2021 18:
00 NO
End Date Time:
Feb/10/2021 10:00
 Repeating
Pages
 4.ADVERSE E
VENT 4  pain at the injection site  Mar/3/2021 17:
00 NO
End Date Time:
Mar/5/2021 12:00
 Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821502
Page 65 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[diarrhea]
4.Start Date Time: Nov/26/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/27/2020 11:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[prepared foods]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821503
Page 66 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821504
Page 67 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[lymphadenomegaly in the right submandibular]
4.Start Date Time: Jan/6/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bacteria]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821505
Page 68 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821506
Page 69 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pain at the injection site]
4.Start Date Time: Feb/8/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 10:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821507
Page 70 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821508
Page 71 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pain at the injection site]
4.Start Date Time: Mar/3/2021 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/5/2021 12:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821509
Page 72 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821510
Page 73 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821511
Page 74 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821512
Page 75 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821513
Page 76 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821514
Page 77 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applica
ble Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821515
Page 78 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821516
Page 79 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821517
Page 80 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821518
Page 81 of 492
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821519
Page 82 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821520
Page 83 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821521
Page 84 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821522
Page 85 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jan/6/2021
Contact Outcome:
VISIT ARRANGED
3.Comments: [PI contacted with subject]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821523
Page 86 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Jan/8/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821524
Page 87 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821525
Page 88 of 492
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821526
Page 89 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821527
Page 90 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821528
Page 91 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821529
Page 92 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821530
Page 93 of 492
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821531
Page 94 of 492
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821532
Page 95 of 492
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821533
Page 96 of 492
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821534
Page 97 of 492
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821535
Page 98 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821536
Page 99 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821537
Page 100 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821538
Page 101 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/8/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821539
Page 102 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Since the V101_VAX3 visit occurs at the same time as the Potential COVID-19
Convalescent visit, the sample collection date and barcodes were recorded at the
original visit(Covid-19 Convalescent visit)]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821540
Page 103 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5CXV]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821541
Page 104 of 492
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 10:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821542
Page 105 of 492
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821543
Page 106 of 492
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821544
Page 107 of 492
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821545
Page 108 of 492
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821546
Page 109 of 492
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5CYZ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821547
Page 110 of 492
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/3/2021 10:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821548
Page 111 of 492
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821549
Page 112 of 492
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821550
Page 113 of 492
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821551
Page 114 of 492
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821552
Page 115 of 492
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821553
Page 116 of 492
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821554
Page 117 of 492
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821555
Page 118 of 492
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/28/2020
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821556
Page 119 of 492
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821557
Page 120 of 492
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Serap Yavuz  Approved Mar-12-2021 17:02:02 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SerapYavuz, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821558
Page 121 of 492
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-06-2020 15:13:25 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821559
Page 122 of 492
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-06-2020 15:16:07 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821560
Page 123 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821561
Page 124 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821562
Page 125 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821563
Page 126 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821564
Page 127 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821565
Page 128 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821566
Page 129 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821567
Page 130 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821568
Page 131 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821569
Page 132 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Jan-08-2021 18:29:04 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821570
Page 133 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-12-2021 17:07:32 (UTC+03:00) Istanbul
FormJan-08-2021 18:29:28 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821571
Page 134 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-12-2021 17:07:32 (UTC+03:00) Istanbul
1Jan-08-2021 18:29:28 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821572
Page 135 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-12-2021 17:07:32 (UTC+03:00) Istanbul
2Jan-08-2021 18:29:28 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821573
Page 136 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-12-2021 17:07:32 (UTC+03:00) Istanbul
3Jan-08-2021 18:29:28 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821574
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-12-2021 17:07:32 (UTC+03:00) Istanbul
4Jan-08-2021 18:29:28 (UTC+03:00) Istanbul Not Done
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821575
Page 138 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821576
Page 139 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821577
Page 140 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821578
Page 141 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821579
Page 142 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821580
Page 143 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821581
Page 144 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-08-2021 18:30:44 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821582
Page 145 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:31:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821583
Page 146 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:31:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821584
Page 147 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:31:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821585
Page 148 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:31:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821586
Page 149 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:31:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821587
Page 150 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821588
Page 151 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821589
Page 152 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821590
Page 153 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821591
Page 154 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821592
Page 155 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821593
Page 156 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821594
Page 157 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821595
Page 158 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821596
Page 159 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821597
Page 160 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821598
Page 161 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821599
Page 162 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821600
Page 163 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821601
Page 164 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821602
Page 165 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821603
Page 166 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821604
Page 167 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821605
Page 168 of 492
***Confidential***
Header Text: C4591001
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821606
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Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821607
Page 170 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821608
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821609
Page 172 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821610
Page 173 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821611
Page 174 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821612
Page 175 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821613
Page 176 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821614
Page 177 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821615
Page 178 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821616
Page 179 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821617
Page 180 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821618
Page 181 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821619
Page 182 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:39 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821620
Page 183 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821621
Page 184 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821622
Page 185 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821623
Page 186 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821624
Page 187 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821625
Page 188 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821626
Page 189 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821627
Page 190 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821628
Page 191 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821629
Page 192 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821630
Page 193 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821631
Page 194 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821632
Page 195 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821633
Page 196 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821634
Page 197 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821635
Page 198 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821636
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821637
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821638
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821639
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Header Text: C4591001
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821640
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821641
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821642
Page 205 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821643
Page 206 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821644
Page 207 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821645
Page 208 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821646
Page 209 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821647
Page 210 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821648
Page 211 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821649
Page 212 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821650
Page 213 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821651
Page 214 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821652
Page 215 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821653
Page 216 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821654
Page 217 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821655
Page 218 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821656
Page 219 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821657
Page 220 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821658
Page 221 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821659
Page 222 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821660
Page 223 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821661
Page 224 of 492
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Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821662
Page 225 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821663
Page 226 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821664
Page 227 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-08-2021 18:31:57 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821665
Page 228 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821666
Page 229 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821667
Page 230 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821668
Page 231 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821669
Page 232 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821670
Page 233 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-08-2021 18:32:15 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821671
Page 234 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:32:31 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821672
Page 235 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:32:31 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821673
Page 236 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-08-2021 18:32:31 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821674
Page 237 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:32:47 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821675
Page 238 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:32:47 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821676
Page 239 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:32:47 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821677
Page 240 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:32:47 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821678
Page 241 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821679
Page 242 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821680
Page 243 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821681
Page 244 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821682
Page 245 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821683
Page 246 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821684
Page 247 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-08-2021 18:33:02 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821685
Page 248 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 18:33:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821686
Page 249 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-08-2021 18:33:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821687
Page 250 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-08-2021 18:33:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821688
Page 251 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-08-2021 18:33:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821689
Page 252 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-08-2021 18:33:17 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821690
Page 253 of 492
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:20:48 (UTC+03:00) Istanbul Since the V101_VAX3 visit occurs at the same
time as the Potential COVID-19 Convalescent
visit, the sample collection date and barcodes
were recorded at the original visit (Potential
Covid-19 Convalescent visit).
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821691
Page 254 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-19-2020 22:00:08 (UTC+03:00) Istanbul PI confirmed that this subject had only diarrhea
due to eating foods that upset the digestive
system and evaluated diarrhea as not COVID
symptoms.
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821692
Page 255 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821693
Page 256 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821694
Page 257 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821695
Page 258 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821696
Page 259 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821697
Page 260 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821698
Page 261 of 492
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Dec-08-2020 14:18:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821707
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821708
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-08-2020 14:19:04 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821709
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821710
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821711
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821712
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821713
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821714
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821715
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821716
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821717
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821718
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821719
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Dec-08-2020 14:19:19 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(
 
 
 
(b) (4)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821722
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821723
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821724
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821725
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821726
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-08-2020 14:19:36 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821727
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-08-2020 14:19:54 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821728
Page 291 of 492
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-08-2020 14:19:54 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821729
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-08-2020 14:19:54 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821730
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Visit: Unplanned 1 - Unscheduled Visit on
Jan/06/2021Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141039 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-08-2021 17:15:14 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d63\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821731
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***Confidential***
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Visit: Unpl
…[truncated]