125742 S1 M5 CRF c4591001 1214 12141018

Document text

Page 1 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821217
Page 2 of 222
***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: 12141018 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/2/2020
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821218
Page 3 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12141018]
2.Birth Date: /1990
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:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821219
Page 4 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821220
Page 5 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821221
Page 6 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathNov/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821222
Page 7 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vertebral disk herniation surgery]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821223
Page 8 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821224
Page 9 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
2.Weight: [88.2]
3.Unit: kg
4.Height: [186.0]
5.Unit: cm
6.Body Mass Index: [25.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821225
Page 10 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/2/2020
2.Randomization Number: [115208]
3.Randomization Group: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821226
Page 11 of 222
***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: 12141018 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/2/2020
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 [BPZD2S]
5.bSample ID [BPZD2T]
5.cSample ID [BSHCW8]
5.dSample ID [BSHCW9]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821227
Page 12 of 222
***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: 12141018 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/2/2020
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 [BPZD2J]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821228
Page 13 of 222
***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: 12141018 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/2/2020 12:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821229
Page 14 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821230
Page 15 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821231
Page 16 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821232
Page 17 of 222
***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: 12141018 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: LEFT
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821233
Page 18 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821234
Page 19 of 222
***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: 12141018 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/23/2020
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 [BPZD72]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821235
Page 20 of 222
***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: 12141018 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/23/2020 09:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821236
Page 21 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821237
Page 22 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821238
Page 23 of 222
***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: 12141018 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: LEFT
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821239
Page 24 of 222
***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: 12141018 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/21/2020
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 [BPZD9H]
5.bSample ID [BPZD9J]
5.cSample ID [BSHD4S]
5.dSample ID [BSHD4T]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821240
Page 25 of 222
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821241
Page 26 of 222
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821242
Page 27 of 222
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821243
Page 28 of 222
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821244
Page 29 of 222
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821245
Page 30 of 222
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821246
Page 31 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821247
Page 32 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821248
Page 33 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821249
Page 34 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821250
Page 35 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821251
Page 36 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821252
Page 37 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821253
Page 38 of 222
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821254
Page 39 of 222
***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: 12141018 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:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821255
Page 40 of 222
***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: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821256
Page 41 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  recurrence vertebral dis
c herniation Nov/18/2020 U
NK:UNK NO
End Date Time:
Dec/2/2020 UNK:U
NK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  spinal fusion surgery  Dec/2/2020 U
NK:UNK NO
End Date Time:
Dec/2/2020 UNK:U
NK
 Repeating
Pages
 3. ADVERSE
EVENT 3  pulmonary embolism  Dec/5/2020 U
NK:UNK NO
End Date Time:
Dec/5/2020 UNK:U
NK
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  Worsening of vertebral
disc herniation Dec/2/2020 U
NK:UNK NO
End Date Time:
Dec/2/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821257
Page 42 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[recurrence vertebral disc herniation]
4.Start Date Time: Nov/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821258
Page 43 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[disk herniation]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020505098]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821259
Page 44 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[spinal fusion surgery ]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821260
Page 45 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[vertebral disc herniation ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[2020505098 ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821261
Page 46 of 222
***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: 12141018 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)[pulmonary embolism]
4.Start Date Time: Dec/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/5/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821262
Page 47 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[immobility and surgery]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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[2020505098]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821263
Page 48 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Worsening of vertebral disc herniation ]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821264
Page 49 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[vertebral disc herniation ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020505098 ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821265
Page 50 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821266
Page 51 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821267
Page 52 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821268
Page 53 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821269
Page 54 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1. DELETED           Repeating
Pages
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821270
Page 55 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ] Comments
2.Category: Comments
3.Concomitant Medications
Pre-specified: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).[ ] Comments
5.Dose: [ ] Comments
6.Dose Unit: Comments
7.Dose Frequency: Comments
8.Route: Comments
9.Start Date: // Comments
10.Ongoing? Comments
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821271
Page 56 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821272
Page 57 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821273
Page 58 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821274
Page 59 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821275
Page 60 of 222
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821276
Page 61 of 222
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821277
Page 62 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821278
Page 63 of 222
***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: 12141018 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:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821279
Page 64 of 222
***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: 12141018 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?
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821280
Page 65 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821281
Page 66 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821282
Page 67 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821283
Page 68 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821284
Page 69 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821285
Page 70 of 222
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 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 [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821286
Page 71 of 222
***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: 12141018 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821287
Page 72 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821288
Page 73 of 222
***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: 12141018 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821289
Page 74 of 222
***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: 12141018 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: [ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821290
Page 75 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821291
Page 76 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821292
Page 77 of 222
***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: 12141018 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
[ ]
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821293
Page 78 of 222
***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: 12141018 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/21/2020
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821294
Page 79 of 222
***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: 12141018 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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821295
Page 80 of 222
***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: 12141018 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 Feb-02-2021 17:00:13 (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.
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0821296
Page 81 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-02-2020 19:58:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821297
Page 82 of 222
***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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-23-2020 11:54:24 (UTC+03:00) Istanbul
FormNov-02-2020 20:00:29 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
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Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821299
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821300
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821301
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821302
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821303
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***Confidential***
Header Text: C4591001
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821304
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***Confidential***
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821305
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821306
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***Confidential***
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821307
Page 92 of 222
***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821308
Page 93 of 222
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Nov-23-2020 11:22:48 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821309
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
FormNov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
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(b) (4)
FDA-CBER-2021-5683-0821310
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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Back to Form
ItemDate User Comment
1Nov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821311
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CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
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Back to Form
ItemDate User Comment
2Nov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-0821312
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
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Back to Form
ItemDate User Comment
3Nov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821313
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
4Nov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
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FDA-CBER-2021-5683-0821314
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
5Nov-23-2020 11:23:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
FormJan-11-2021 10:54:48 (UTC+03:00) Istanbul
FormNov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
1Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
1Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
2Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
2Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
3Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
3Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
4Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
4Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
5Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
5Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
6Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
7Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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ItemDate User Comment
8Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
8Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
9Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
9Nov-23-2020 11:23:30 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
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ItemDate User Comment
10Jan-11-2021 10:54:48 (UTC+03:00) Istanbul
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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ItemDate User Comment
FormNov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
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Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
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Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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ItemDate User Comment
1Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
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(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821328
Page 113 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821329
Page 114 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821330
Page 115 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821331
Page 116 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821332
Page 117 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-23-2020 11:23:50 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821333
Page 118 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-23-2020 11:24:10 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821334
Page 119 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-23-2020 11:24:10 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821335
Page 120 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-23-2020 11:24:10 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821336
Page 121 of 222
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-30-2020 19:44:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821337
Page 122 of 222
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-30-2020 19:44:23 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821338
Page 123 of 222
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-04-2021 11:03:11 (UTC+03:00) Istanbul Not Applicable
FormDec-31-2020 17:45:20 (UTC+03:00) Istanbul
FormDec-30-2020 19:44:38 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821339
Page 124 of 222
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-04-2021 11:03:11 (UTC+03:00) Istanbul Not Applicable
1Dec-31-2020 17:45:20 (UTC+03:00) Istanbul
1Dec-30-2020 19:44:38 (UTC+03:00) Istanbul Not Applicable
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821340
Page 125 of 222
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Serap Yavuz  Approved Feb-02-2021 17:00:13 (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.
 N/A Feb-01-2021 18:51:31 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Jan-28-2021 23:31:07 (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.
 N/A Jan-28-2021 16:39:02 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Jan-12-2021 22:14:11 (UTC+03:00) Istanbul BOOK Signed
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821341
Page 126 of 222
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.
 N/A Jan-12-2021 17:10:27 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Jan-11-2021 17:30:42 (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.
 N/A Jan-08-2021 12:20:11 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Jan-08-2021 12:17:26 (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.
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821342
Page 127 of 222
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Jan-08-2021 12:10:47 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Jan-07-2021 11:19:57 (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.
 N/A Jan-04-2021 11:03:11 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Dec-31-2020 18:52:24 (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.
 N/A Dec-30-2020 14:20:00 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Dec-23-2020 10:51:41 (UTC+03:00) Istanbul BOOK Signed
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821343
Page 128 of 222
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.
 N/A Dec-22-2020 12:12:42 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Dec-22-2020 10:50:50 (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.
 N/A Dec-21-2020 11:15:33 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Dec-02-2020 11:03:55 (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.
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821344
Page 129 of 222
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Nov-23-2020 11:22:32 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Serap Yavuz  Approved Nov-20-2020 15:50:18 (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.
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821345
Page 130 of 222
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-02-2020 19:56:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-02-2020 19:56:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821346
Page 131 of 222
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-02-2020 19:57:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/2/2020Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821347
Page 132 of 222
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-02-2020 19:56:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12141018Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-02-2020 19:56:37
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1990Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-02-2020 19:57:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-02-2020 19:57:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-02-2020 19:57:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821348
Page 133 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 19:58:07
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821349
Page 134 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-02-2020 19:59:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 19:59:09
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 19:59:09
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821350
Page 135 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-23-2020 11:55:18
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:vertebral disk herni
ation surgery
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/201
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-23-2020 11:55:18
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 11:55:18
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
vertebral disk herniation surgeryInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-23-2020 11:55:18
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-23-2020 11:55:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821351
Page 136 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+03:00) Istanbul NO
End Date:
UNK/UNK/2010
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821352
Page 137 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-02-2020 20:00:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821353
Page 138 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
88.2Initial Entry
3. Unit:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
186.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.5Initial Entry
7.a
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821354
Page 139 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locati
on::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-02-2020 20:02:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821355
Page 140 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-02-2020 20:02:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-02-2020 20:02:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
115208Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821356
Page 141 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 20:03:05
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 20:03:05
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 20:48:42
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 20:03:05
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-02-2020 20:03:05
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 20:48:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD2SInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821357
Page 142 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-02-2020 20:48:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD2SInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 20:48:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD2TInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 20:48:54
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD2TInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 20:49:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHCW8Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 20:49:03
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHCW8Initial Entry
5.d
Date Location User Value Reason
Nov-02-2020 20:49:17
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHCW9Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-02-2020 20:49:17
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHCW9Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821358
Page 143 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 20:03:25
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 20:03:25
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 20:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 20:03:25
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-02-2020 20:03:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 20:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD2JInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821359
Page 144 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-02-2020 20:48:30
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD2JInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821360
Page 145 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020 12:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821361
Page 146 of 222
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-02-2020 20:04:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821362
Page 147 of 222
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-02-2020 20:04:26
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821363
Page 148 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 11:24:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821364
Page 149 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FATInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821365
Page 150 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
IG
UE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NO
2.b Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821366
Page 151 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821367
Page 152 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821368
Page 153 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821369
Page 154 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821370
Page 155 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821371
Page 156 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-23-2020 11:25:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821372
Page 157 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
2.a
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821373
Page 158 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-23-2020 11:25:41
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821374
Page 159 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 11:25:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 11:25:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 11:51:47
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 11:25:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 11:25:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/23/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 11:51:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD72Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821375
Page 160 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-23-2020 11:51:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD72Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821376
Page 161 of 222
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/23/2020 09:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821377
Page 162 of 222
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-23-2020 11:26:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821378
Page 163 of 222
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 11:15:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821379
Page 164 of 222
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: FATInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821380
Page 165 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
IG
UE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NO
2.b Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821381
Page 166 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.c Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821382
Page 167 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821383
Page 168 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821384
Page 169 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821385
Page 170 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821386
Page 171 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-21-2020 11:16:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821387
Page 172 of 222
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-21-2020 11:16:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-21-2020 11:16:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-21-2020 14:05:24
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 11:16:51
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-21-2020 11:16:51
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Dec-21-2020 14:05:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD9HInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821388
Page 173 of 222
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-21-2020 14:05:24
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD9HInitial Entry
5.b
Date Location User Value Reason
Dec-21-2020 14:05:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BPZD9JInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-21-2020 14:05:36
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BPZD9JInitial Entry
5.c
Date Location User Value Reason
Dec-21-2020 14:05:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHD4SInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-21-2020 14:05:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHD4SInitial Entry
5.d
Date Location User Value Reason
Dec-21-2020 14:05:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Sample ID: BSHD4TInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-21-2020 14:05:57
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
BSHD4TInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821389
Page 174 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821390
Page 175 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-08-2021 12:25:16
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Deleted Transcription
Error
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821391
Page 176 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821392
Page 177 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-28-2021 16:39:02
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Deleted Changed
Information
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000 Form Created
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821393
Page 178 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-28-2021 16:40:55
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
recurrence vertebral disc herniatio
nTranscription Error
Jan-08-2021 19:38:22
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-08-2021 12:10:47
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
recurrent vertebral disk herniationTranscription Error
Jan-06-2021 09:44:56
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered recurrent vertebral
disc herniation
Jan-05-2021 21:16:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if the term
should be
"Worsening of
vertebral disc
herniation" or
"Recurrent vertebral
disc herniation" or
and make the change
as appropriate.
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
vertebral disk herniationInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821394
Page 179 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-22-2020 12:12:42
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKNew Information
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 00:09:08
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Response satisfies
query
Feb-02-2021 11:34:12
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-02-2021 11:34:12
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Transcription Error
Feb-01-2021 18:37:35
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened GPDClin: As this
AE required bed rest
and analgesic, then
ultimately required
surgery and
hospitalization, a
higher grade/severity
may be more
appropriate.
Jan-08-2021 19:38:37
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821395
Page 180 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-06-2021 10:01:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered When AE was
reported, surgery was
not required so grade
was determined as
G1. Grade of surgery
was alreay
determined as G2.
Jan-05-2021 21:19:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: As this
AE ultimately
required surgery and
hospitalization, a
higher grade/severity
may be more
appropriate. If agree,
please make
appropriate change.
Dec-22-2020 13:54:33
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered When AE was
reported, surgery was
not required so grade
was determined as
G1
Dec-22-2020 10:27:44
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: For a AE
requiring surgery
intervention, its
grade can not be
mild (G1), please
report the AE grade
appropriately.
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Feb-01-2021 18:51:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821396
Page 181 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-28-2021 16:43:52
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE recurrence
vertebral disc
herniation: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-28-2021 16:43:52
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability
/incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
NOChanged Information
Jan-08-2021 19:38:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821397
Page 182 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-06-2021 09:59:14
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered When AE was
reported,
hospitalization was
not needed and it
was reported as AE.
For the rest, surgery
and hospitalization
was reported as SAE
when they were
needed.
Jan-05-2021 21:22:45
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Per SAE
report, this AE
ultimately resulted in
surgery and
hospitalization.
Therefore, it should
be a SAE (per
hospitalization
criterion). The fusion
surgery was not an
AE/SAE, but was the
non-drug treatment
of this SAE.
Dec-22-2020 13:51:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered When AE was
reported, surgery was
not required.
Dec-22-2020 10:29:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: As this
AE resulted in
hospitalization for
surgery, it should be
reported as a SAE
due to
hospitalization.
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821398
Page 183 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
disk herniationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020 19:12:13
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Dec-22-2020 13:54:58
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Dec-22-2020 13:54:58
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESChanged
Information
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821399
Page 184 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-22-2020 10:30:53
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: As
surgery (which is a
non-drug treatment)
was performed for
this condition,
please update this to
"Yes".
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020 13:52:25
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-22-2020 13:52:25
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-22-2020 12:12:42
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE vertebral
disk herniation:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020 11:22:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821400
Page 185 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Feb-01-2021 18:51:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2020505098Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821401
Page 186 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021 19:42:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-06-2021 09:44:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered spinal fusion surgery
caused the
hospitalization so it
was commented as
SAE
Jan-05-2021 21:26:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Per
protocol 10.3.1, the
spinal fusion surgery
should not be an
AE/SAE, but the
non-drug treatment
for the SAE of
vertebral disc
herniation (please
see query for the
AE). Please remove
this from the AE log.
Dec-22-2020 13:53:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered When AE ( vertebral
disk herniation) was
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821402
Page 187 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
reported, surgery was
not required.
Dec-22-2020 10:24:44
(UTC+03:00) IstanbulACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per
Protocol 10.3.1,
Medical or surgical
procedure is not an
AE, but the condition
that leads to the
procedure is the AE.
Therefore, please
remove it from AE
log and report the
other AE, "vertebral
disk herniation" as a
SAE.
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
spinal fusion surgeryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020 14:29:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/2/2020 UNK:UNKTranscription Error
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-21-2020 14:29:34
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKTranscription Error
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821403
Page 188 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec/5/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-21-2020 14:26:13
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Dec-31-2020 11:51:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Dec-23-2020 11:10:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Answered Subject reported SAE
to study site on
21Dec2020. SAE
was reported to
Pfizer on 21Dec2020
Dec-22-2020 17:39:27
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 2: Opened SAE RECON:spinal
fusion surgery(Onset
date:02Dec2020) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Dec-22-2020 16:50:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821404
Page 189 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE spinal fusion
surgery: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821405
Page 190 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
vertebral disc herniationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821406
Page 191 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-21-2020 14:22:31
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-31-2020 11:50:28
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2020505098Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821407
Page 192 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021 17:17:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-05-2021 11:11:15
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered All lab results were
reported in SAE form
and source document
for SAE
Jan-04-2021 17:19:50
(UTC+03:00) IstanbulACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thank you for your
response. Kindly
provide
work-up/imaging and
other lab tests
performed during
hospital stay in a FU
form. Thanks!
Dec-24-2020 11:59:06
(UTC+03:00) IstanbulACV0PFEINFP6000  Query 1: Answered Subject said that
COVID-19 test
worked up in hospital
and result was
negative.
Dec-23-2020 23:17:29
(UTC+03:00) IstanbulACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_
AER#2020505098.
Per SAE form
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0821408
Page 193 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
submitted to safety,
subject was
hospitalized during
10 days, however
work-up/imaging and
lab tests (including
covid test) are not
reported. Kindly
provide missing
information in a FU
report. Thank you.
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
pulmonary embolismInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/5/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821409
Page 194 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-22-2020 15:01:19
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE pulmonary
embolism: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s eventInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821410
Page 195 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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.
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
immobility and surgeryInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821411
Page 196 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
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: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-21-2020 14:28:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020 15:01:19
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2020505098Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821412
Page 197 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Worsening of vertebral disc herniati
onInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-08-2021 12:20:32
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-08-2021 12:20:32
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Dec/2/2020 UNK:UNKTranscription Error
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Worsening
of vertebral disc
herniation: Start
Date is the same as a
Vaccination Date,
but time is not
provided. Please
review and update as
appropriate.
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821413
Page 198 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Nov/2/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-08-2021 12:22:02
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Jan-11-2021 10:21:46
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 12:21:43
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-08-2021 12:21:43
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NOTranscription Error
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821414
Page 199 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
NO
Jan-08-2021 12:21:16
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Did this serious event require or
prolong hospitalization?
YES
Other medically important seriou
s eventTranscription Error
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria
is missing. Please
review and update as
appropriate.
Jan-08-2021 12:20:11 ACV0PFEINFP6000  auto query Query 1: Candidate For AE Worsening
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821415
Page 200 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC+03:00) Istanbul (autoquery) of vertebral disc
herniation: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YES
Other medically important seriou
s event
YESInitial Entry
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.
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-08-2021 12:22:45
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
vertebral disc herniationTranscription Error
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHERInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821416
Page 201 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-08-2021 12:20:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-11-2021 10:21:46
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
2020505098Initial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821417
Page 202 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0821418
Page 203 of 222
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-23-2020 11:22:48
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0821419
Page 204 of 222
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1214 Site Name: (1214) ISTANBUL UNIVERSITY MEDICAL FACULTY
CARDIOLOGY INSTITUTE
Subject No: 12141018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-23-2020 11:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Nov-23-2020 11:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-23-2020 11:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
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).
Date Location User Value Reason
Nov-23-2020 11:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Nov-23-2020 11:23:11
(UTC+03:00) IstanbulACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d5d\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(
…[truncated]