125742 S1 M5 CRF c4591001 1217 12171044

Document text

Page 1 of 622
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822382
Page 2 of 622
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/4/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822383
Page 3 of 622
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12171044]
2.Birth Date: /1985
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:
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822384
Page 4 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822385
Page 5 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822386
Page 6 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822387
Page 7 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822388
Page 8 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822389
Page 9 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
2.Weight: [97.0]
3.Unit: kg
4.Height: [185.0]
5.Unit: cm
6.Body Mass Index: [28.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822390
Page 10 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/4/2020
2.Randomization Number: [115479]
3.Randomization Group: [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822391
Page 11 of 622
***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, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/4/2020
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 [BPZ97B]
5.bSample ID [BPZ97C]
5.cSample ID [BS2S65]
5.dSample ID [BS2S66]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822392
Page 12 of 622
***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, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/4/2020
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 [BPZ978]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822393
Page 13 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/4/2020 14:20
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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822394
Page 14 of 622
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822395
Page 15 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822396
Page 16 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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?YES
Ongoing?
YES
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?YES
Ongoing?
NO
Stop Date:
Dec/10/2020
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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822397
Page 17 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Dec/10/2020
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822398
Page 18 of 622
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822399
Page 19 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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:
Dec/10/2020
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 [BPZ9CM]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822400
Page 20 of 622
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822401
Page 21 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822402
Page 22 of 622
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
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?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822403
Page 23 of 622
***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, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?Not Done Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822404
Page 24 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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:
Jan/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN896M]
5.bSample ID [BN896N]
5.cSample ID [BS2S8S]
5.dSample ID [BS2S8T]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822405
Page 25 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822406
Page 26 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822407
Page 27 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822408
Page 28 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822409
Page 29 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822410
Page 30 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822411
Page 31 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822412
Page 32 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/12/2020
2.Date of First Symptom Started: Nov/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/9/2021Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [sweating]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822413
Page 33 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Co
llectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/10/202
0 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
 2.Nov/16/202
0 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822414
Page 34 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/10/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CORONEX-COVID 19 RT-qPCR Test] Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822415
Page 35 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/16/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822416
Page 36 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[the nasal swab was collected in the hospital.patient has not used SELF
SWAB kit.]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822417
Page 37 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/12/2020
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 [BPZ9GC]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822418
Page 38 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822419
Page 39 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Nov/11/2020  NO
Discharge Date:
Nov/16/2020
 Repeating Pages
 2.HOSPITALIZATION STATUS  HOSPITAL   Nov/20/2020  NO
Discharge Date:
Nov/29/2020
 Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822420
Page 40 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/11/2020
4.Ongoing? NO
Discharge Date:
Nov/16/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822421
Page 41 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/20/2020
4.Ongoing? NO
Discharge Date:
Nov/29/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822422
Page 42 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatmen
t Identifie
rCon Non-Drug Tre
atments Pre-specifi
edTreatment TreatmentStart
DateForm Insta
nce
 1. 1  YES  NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON Nov/2
0/2020
 Repeating
Pages
 2. DELETED 2  YES  HIGH FLOW OXYGEN T
HERAPY HIGH FLOW OXYGEN T
HERAPY Nov/2
0/2020
 Repeating
Pages
 3. 3  YES  HIGH FLOW OXYGEN T
HERAPY HIGH FLOW OXYGEN T
HERAPY Nov/2
2/2020
 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822423
Page 43 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: NON-INVASIVE POSITIVE PRESSURE VENTILATION Comments
4.Treatment: [NON-INVASIVE POSITIVE PRESSURE VENTILATION]
5.Start Date: Nov/20/2020 Comments
6.Ongoing? NO
End Date:
Nov/21/2020Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822424
Page 44 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Respiratory Treatment
1.What is the treatment Identifier? [2]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/21/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822425
Page 45 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [3]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Nov/22/2020
6.Ongoing? NO
End Date:
Nov/28/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822426
Page 46 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Covid-19]
Date of Diagnosis:
Nov/10/2020Comments
3.Toxicity Grade: 2 Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822427
Page 47 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1. DELETED Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822428
Page 48 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822429
Page 49 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICA
L CHEMI
STRY Kocaeli Universitesi Arastirma ve Uygulama Ha
stanesi Merkez Laboratuvari, Umuttepe 41380 K
ocaeli ,TURKEY Nov/1
0/2020
 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 6.5
6 
30  Alanine Ami
notransferase
_PX30 43.
2 
28  Aspartate A
minotransfer
ase_PX28 28.
9 
35  Alkaline Pho
sphatase_PX
35 74 
21  Bilirubin_PX
21 0.4
7 
47  Blood Urea
Nitrogen_PX
47 [ ] 
48  Creatinine_P
X48 0.8
6 Repeating
Pages
 2.CLINICA
L CHEMI
STRY Lab Name:Kocaeli Universitesi Arastirma ve Uy
gulama Hastanesi Merkez Laboratuvari, Address
: Umuttepe 41380 Kocaeli ,TURKEY Nov/1
6/2020
 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 4.6
0 
30  Alanine Ami
notransferase
_PX30 101
.5 
28  Aspartate A
minotransfer
ase_PX28 49.
0 
35  Alkaline Pho
sphatase_PX
35 50 
21  Bilirubin_PX
21 0.5
4 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822430
Page 50 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
47  Blood Urea
Nitrogen_PX
47 13 
48  Creatinine_P
X48 0.7
6 
 3.CLINICA
L CHEMI
STRY Lab Name:Kocaeli Universitesi Arastirma ve Uy
gulama Hastanesi Merkez Laboratuvari, Address
: Umuttepe 41380 Kocaeli ,TURKEY Nov/2
0/2020
 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 44.
77 
30  Alanine Ami
notransferase
_PX30 160
.8 
28  Aspartate A
minotransfer
ase_PX28 66.
7 
35  Alkaline Pho
sphatase_PX
35 53 
21  Bilirubin_PX
21 0.5
9 
47  Blood Urea
Nitrogen_PX
47 13 
48  Creatinine_P
X48 0.9
3 Repeating
Pages
 4.CLINICA
L CHEMI
STRY Lab Name:Kocaeli Universitesi Arastirma ve Uy
gulama Hastanesi Merkez Laboratuvari, Address
: Umuttepe 41380 Kocaeli ,TURKEY Nov/2
3/2020
 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 9.6
2 
30  Alanine Ami
notransferase
_PX30 219
.3 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822431
Page 51 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
28  Aspartate A
minotransfer
ase_PX28 76.
4 
35  Alkaline Pho
sphatase_PX
35 55 
21  Bilirubin_PX
21 0.5
1 
47  Blood Urea
Nitrogen_PX
47 17 
48  Creatinine_P
X48 0.8
1 
 5.CLINICA
L CHEMI
STRY Kocaeli Universitesi Arastirma ve Uygulama Ha
stanesi Merkez Laboratuvari, Umuttepe 41380 K
ocaeli ,TURKEY Nov/2
9/2020
 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 1.0
2 
30  Alanine Ami
notransferase
_PX30 187
.1 
28  Aspartate A
minotransfer
ase_PX28 36.
3 
35  Alkaline Pho
sphatase_PX
35 74 
21  Bilirubin_PX
21 0.4
3 
47  Blood Urea
Nitrogen_PX
47 19 
48  Creatinine_P
X48 0.8
7 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822432
Page 52 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez Laboratuvari,
Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/10/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [6.56] Comments
Not Done: Comments
LNMT Low
[0]
High
[5]
Unit
mg/LComments
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [43.2]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822433
Page 53 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [28.9]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [74]
Not Done:
LNMT Low
[30]
High
[120]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.47]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822434
Page 54 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.86]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822435
Page 55 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/16/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [4.60]
Not Done:
LNMT Low
[0]
High
[5]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [101.5]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822436
Page 56 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [49.0]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [50]
Not Done:
LNMT Low
[30]
High
[120]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.54]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822437
Page 57 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[7]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.76]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822438
Page 58 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/20/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [44.77]
Not Done:
LNMT Low
[0]
High
[5]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [160.8]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822439
Page 59 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [66.7]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [53]
Not Done:
LNMT Low
[30]
High
[120]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.59]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822440
Page 60 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[7]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.93]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822441
Page 61 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [9.62]
Not Done:
LNMT Low
[0]
High
[5]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [219.3]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822442
Page 62 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [76.4]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [55]
Not Done:
LNMT Low
[30]
High
[120]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.51]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822443
Page 63 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [17]
Not Done:
LNMT Low
[7]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.81]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822444
Page 64 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez Laboratuvari,
Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/29/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.02]
Not Done:
LNMT Low
[0]
High
[5]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [187.1]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822445
Page 65 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [36.3]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [74]
Not Done:
LNMT Low
[30]
High
[120]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.43]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822446
Page 66 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[7]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.87]
Not Done:
LNMT Low
[0.67]
High
[1.17]
Unit
mg/dL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822447
Page 67 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
 1.HEMAT
OLOGY Kocaeli Universitesi Arastirma ve Uygulama Hasta
nesi Merkez Laboratuvari, Umuttepe 41380 Kocaeli
,TURKEY Nov/10
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 15.
11 
2  Hematoc
rit_PX2 43.
32 
3  Erythroc
ytes_PX
3 5.1
01 
5  Platelets
_PX5 240
.9 
7  Leukocyt
es_PX7 8.6
58 
608  Neutroph
ils_PX60
8 6.8
36 
609  Eosinoph
ils_PX60
9 0.0
95 
612  Monocyt
es_PX61
2 0.8
71 
610  Basophil
s_PX610
 0.0
27 
611  Lymphoc
ytes_PX
611 0.8
30 Repeating
Pages
 2.HEMAT
OLOGY Lab Name:Kocaeli Universitesi Arastirma ve Uygul
ama Hastanesi Merkez Laboratuvari, Address: Umu
ttepe 41380 Kocaeli ,TURKEY Nov/16
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 16.
17 
2  Hematoc
rit_PX2 45.
27 
3  Erythroc
ytes_PX5.3
55 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822448
Page 68 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-D
efined Ide
ntifierTest:Res
ult:
3 
5  Platelets
_PX5 200
.6 
7  Leukocyt
es_PX7 7.1
15 
608  Neutroph
ils_PX60
8 5.5
96 
609  Eosinoph
ils_PX60
9 0.0
00 
612  Monocyt
es_PX61
2 0.3
86 
610  Basophil
s_PX610
 0.0
15 
611  Lymphoc
ytes_PX
611 1.1
18 
 3.HEMAT
OLOGY Lab Name:Kocaeli Universitesi Arastirma ve Uygul
ama Hastanesi Merkez Laboratuvari, Address: Umu
ttepe 41380 Kocaeli ,TURKEY Nov/20
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 14.
94 
2  Hematoc
rit_PX2 42.
58 
3  Erythroc
ytes_PX
3 5.0
60 
5  Platelets
_PX5 208
.8 
7  Leukocyt
es_PX7 10.
915
 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822449
Page 69 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-D
efined Ide
ntifierTest:Res
ult:
608  Neutroph
ils_PX60
8 8.7
17 
609  Eosinoph
ils_PX60
9 0.0
01 
612  Monocyt
es_PX61
2 0.9
39 
610  Basophil
s_PX610
 0.0
31 
611  Lymphoc
ytes_PX
611 1.2
26 
 4.HEMAT
OLOGY Lab Name:Kocaeli Universitesi Arastirma ve Uygul
ama Hastanesi Merkez Laboratuvari, Address: Umu
ttepe 41380 Kocaeli ,TURKEY Nov/23
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 14.
81 
2  Hematoc
rit_PX2 42.
79 
3  Erythroc
ytes_PX
3 5.1
52 
5  Platelets
_PX5 304
.7 
7  Leukocyt
es_PX7 7.7
10 
608  Neutroph
ils_PX60
8 5.2
73 
609  Eosinoph
ils_PX60
9 0.0
53 
612  Monocyt 0.4Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822450
Page 70 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-D
efined Ide
ntifierTest:Res
ult:
es_PX61
2 78 
610  Basophil
s_PX610
 0.0
48 
611  Lymphoc
ytes_PX
611 1.8
58 
 5.HEMAT
OLOGY Kocaeli Universitesi Arastirma ve Uygulama Hasta
nesi Merkez Laboratuvari, Umuttepe 41380 Kocaeli
,TURKEY Nov/29
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1  Hemoglo
bin_PX1 14.
53 
2  Hematoc
rit_PX2 43.
33 
3  Erythroc
ytes_PX
3 5.1
11 
5  Platelets
_PX5 397
.6 
7  Leukocyt
es_PX7 18.
281
 
608  Neutroph
ils_PX60
8 13.
698
 
609  Eosinoph
ils_PX60
9 0.0
86 
612  Monocyt
es_PX61
2 1.3
27 
610  Basophil
s_PX610
 0.0
60 
611  Lymphoc 3.1Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822451
Page 71 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-D
efined Ide
ntifierTest:Res
ult:
ytes_PX
611 10 
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822452
Page 72 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez Laboratuvari,
Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/10/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.11]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43.32]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822453
Page 73 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.101]
Not Done:
LNMT Low
[4.06]
High
[5.63]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [240.9]
Not Done:
LNMT Low
[152]
High
[348]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [8.658]
Not Done:
LNMT Low
[3.6]
High
[10.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822454
Page 74 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [6.836]
Not Done:
LNMT Low
[1.7]
High
[7.6]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.095]
Not Done:
LNMT Low
[0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.871]
Not Done:
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822455
Page 75 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.027]
Not Done:
LNMT Low
[0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [0.830] Comments
Not Done: Comments
LNMT Low
[1]
High
[3.2]
Unit
10^3/uLComments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822456
Page 76 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/16/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [16.17]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [45.27]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822457
Page 77 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.355]
Not Done:
LNMT Low
[4.06]
High
[5.63]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [200.6]
Not Done:
LNMT Low
[152]
High
[348]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [7.115]
Not Done:
LNMT Low
[3.6]
High
[10.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822458
Page 78 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.596]
Not Done:
LNMT Low
[1.7]
High
[7.6]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.000]
Not Done:
LNMT Low
[0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.386]
Not Done:
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822459
Page 79 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.015]
Not Done:
LNMT Low
[0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.118]
Not Done:
LNMT Low
[1]
High
[3.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822460
Page 80 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/20/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.94]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [42.58]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822461
Page 81 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.060]
Not Done:
LNMT Low
[4.06]
High
[5.63]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [208.8]
Not Done:
LNMT Low
[152]
High
[348]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [10.915]
Not Done:
LNMT Low
[3.6]
High
[10.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822462
Page 82 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [8.717]
Not Done:
LNMT Low
[1.7]
High
[7.6]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.001]
Not Done:
LNMT Low
[0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.939]
Not Done:
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822463
Page 83 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.031]
Not Done:
LNMT Low
[0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.226]
Not Done:
LNMT Low
[1]
High
[3.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822464
Page 84 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Lab Name:Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez
Laboratuvari, Address: Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.81]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [42.79]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822465
Page 85 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.152]
Not Done:
LNMT Low
[4.06]
High
[5.63]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [304.7]
Not Done:
LNMT Low
[152]
High
[348]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [7.710]
Not Done:
LNMT Low
[3.6]
High
[10.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822466
Page 86 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.273]
Not Done:
LNMT Low
[1.7]
High
[7.6]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.053]
Not Done:
LNMT Low
[0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.478]
Not Done:
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822467
Page 87 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.048]
Not Done:
LNMT Low
[0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.858]
Not Done:
LNMT Low
[1]
High
[3.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822468
Page 88 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Kocaeli Universitesi Arastirma ve Uygulama Hastanesi Merkez Laboratuvari,
Umuttepe 41380 Kocaeli ,TURKEY]
3.Collection Date: Nov/29/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.53]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43.33]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822469
Page 89 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.111]
Not Done:
LNMT Low
[4.06]
High
[5.63]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [397.6]
Not Done:
LNMT Low
[152]
High
[348]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [18.281]
Not Done:
LNMT Low
[3.6]
High
[10.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822470
Page 90 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [13.698]
Not Done:
LNMT Low
[1.7]
High
[7.6]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.086]
Not Done:
LNMT Low
[0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.327]
Not Done:
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822471
Page 91 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.060]
Not Done:
LNMT Low
[0]
High
[0.1]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [3.110]
Not Done:
LNMT Low
[1]
High
[3.2]
Unit
10^3/uL
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822472
Page 92 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Nov/12/2020 Record Identifier: Systolic: Diastolic:
1  130  80 Repeating Pages
 2.Nov/20/2020 Record Identifier: Systolic: Diastolic:
1  110  70 Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822473
Page 93 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [130]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [95]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822474
Page 94 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [110]
Diastolic: [70]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [80]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822475
Page 95 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Nov/11/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 2.Nov/20/2020 Record Identifier: Oxygen Saturation
1  94.0 Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822476
Page 96 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822477
Page 97 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/20/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822478
Page 98 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Nov/20/2020 18:00  65  0.69  Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822479
Page 99 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Nov/20/2020 18:00 Comments
2.Arterial Blood Gases PaO2 (mmHg): [65] Comments
3.FiO2 (Fraction of Inhaled Oxygen): [0.69] Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822480
Page 100 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Def
ined Identifi
erCategory for Medica
tionConcomitant Med
ications Pre-specif
iedName of MedicationStart
DateForm Insta
nce
 1. DELETED 1  GENERAL CONCO
MITANT MEDICATI
ONS NO  Favipiravir(loading dose:2x160
0 mg,oral) Nov/1
1/2020
 Repeating
Pages
 2. DELETED 2  GENERAL CONCO
MITANT MEDICATI
ONS NO  Azithromycin(loading dose;1x5
00 mg,oral) Nov/1
4/2020
 Repeating
Pages
 3. DELETED 3  GENERAL CONCO
MITANT MEDICATI
ONS NO  PRECORT-LIYO (METHYLP
REDNISOLONE,1x 40 mg, IV
) Nov/1
5/2020
 Repeating
Pages
 4. DELETED 4  GENERAL CONCO
MITANT MEDICATI
ONS NO  LANSAZOL (Lansoprazole, 30
mg, 1x1 oral) Nov/1
1/2020
 Repeating
Pages
 5. DELETED 5  GENERAL CONCO
MITANT MEDICATI
ONS NO  MUSCORIL (THIOCOLCHIC
OSIDE Injection, 4 mg/2 mg, I
V, 1x1) Nov/1
1/2020
 Repeating
Pages
 6. DELETED 6  GENERAL CONCO
MITANT MEDICATI
ONS NO  OKSAPAR (ENOXAPARIN S
ODIUM, 1x0.6ml,subcutaneou
s) Nov/1
1/2020
 Repeating
Pages
 7. DELETED 7  GENERAL CONCO
MITANT MEDICATI
ONS NO  OKSAPAR (ENOXAPARIN S
ODIUM, 1x0.6 ml,subcutaneou
s) Nov/1
7/2020
 Repeating
Pages
 8. DELETED 8  GENERAL CONCO
MITANT MEDICATI
ONS NO  DEXAMETHASONE (6 mg, 1
x1, oral) Nov/1
7/2020
 Repeating
Pages
 9. DELETED 9  GENERAL CONCO
MITANT MEDICATI
ONS NO  Azithromycin (1x250 mg,oral)  Nov/1
7/2020
 Repeating
Pages
 10. DELETED 10  GENERAL CONCO
MITANT MEDICATI
ONS NO  CLEXANE(ENOXAPARIN S
ODIUM 1x0.8 mg,subcutaneou
s) Nov/2
0/2020
 Repeating
Pages
 11. DELETED 11  GENERAL CONCO
MITANT MEDICATI
ONS NO  Teicoplanin (1x400 mg IV)  Nov/2
0/2020
 Repeating
Pages
 12. DELETED 12  GENERAL CONCO
MITANT MEDICATI
ONS NO  Piperacillin - tazobactam (3x4.
5 g/day IV) Nov/2
0/2020
 Repeating
Pages
 13. DELETED 13  GENERAL CONCO
MITANT MEDICATI
ONS NO  Tocilizumab (1x400 mg IV)  Nov/2
0/2020
 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822481
Page 101 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Def
ined Identifi
erCategory for Medica
tionConcomitant Med
ications Pre-specif
iedName of MedicationStart
DateForm Insta
nce
 14. DELETED 14  GENERAL CONCO
MITANT MEDICATI
ONS NO  Oxygen mask (12 L/MIN)  Nov/2
0/2020
 Repeating
Pages
 15. DELETED 15  GENERAL CONCO
MITANT MEDICATI
ONS NO  Favipiravir(2x600 mg,oral)  Nov/1
2/2020
 Repeating
Pages
 16. DELETED 16  GENERAL CONCO
MITANT MEDICATI
ONS NO  Azithromycin(1x250 mg,oral)  Nov/1
5/2020
 Repeating
Pages
 17. DELETED 17  GENERAL CONCO
MITANT MEDICATI
ONS NO  Nasal Cannula oxygen (6 L/MI
N) Nov/2
2/2020
 Repeating
Pages
 18. DELETED 18  GENERAL CONCO
MITANT MEDICATI
ONS NO  Teicoplanin (loading dose,2x40
0 mg IV) Nov/2
0/2020
 Repeating
Pages
 19. DELETED 19  GENERAL CONCO
MITANT MEDICATI
ONS NO  Lansazol (lansoprazole, 30 mg,
1x1 oral) Nov/2
0/2020
 Repeating
Pages
 20. DELETED 20  GENERAL CONCO
MITANT MEDICATI
ONS NO  Seralin (sertralin, 50 mg, 1x1 o
ral) Nov/2
0/2020
 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822482
Page 102 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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? [1] Comments
2.Category: GENERAL CONCOMITANT MEDICATIONS Comments
3.Concomitant Medications
Pre-specified:NO 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).[Favipiravir(loading dose:2x1600 mg,oral) ] Comments
5.Start Date: Nov/11/2020 Comments
6.Ongoing? NO
End Date:
Nov/11/2020Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822483
Page 103 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Azithromycin(loading dose;1x500 mg,oral) ]
5.Start Date: Nov/14/2020
6.Ongoing? NO
End Date:
Nov/14/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822484
Page 104 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[PRECORT-LIYO (METHYLPREDNISOLONE,1x 40 mg, IV) ]
5.Start Date: Nov/15/2020
6.Ongoing? NO
End Date:
Nov/16/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822485
Page 105 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [4]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[LANSAZOL (Lansoprazole, 30 mg, 1x1 oral) ]
5.Start Date: Nov/11/2020
6.Ongoing? NO
End Date:
Nov/16/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822486
Page 106 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [5]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[MUSCORIL (THIOCOLCHICOSIDE Injection, 4 mg/2 mg, IV, 1x1) ]
5.Start Date: Nov/11/2020
6.Ongoing? NO
End Date:
Nov/16/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822487
Page 107 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [6]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[OKSAPAR (ENOXAPARIN SODIUM, 1x0.6ml,subcutaneous) ]
5.Start Date: Nov/11/2020
6.Ongoing? NO
End Date:
Nov/19/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822488
Page 108 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [7]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[OKSAPAR (ENOXAPARIN SODIUM, 1x0.6 ml,subcutaneous) ]
5.Start Date: Nov/17/2020
6.Ongoing? NO
End Date:
Nov/19/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822489
Page 109 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [8]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[DEXAMETHASONE (6 mg, 1x1, oral) ]
5.Start Date: Nov/17/2020
6.Ongoing? YES
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822490
Page 110 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [9]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Azithromycin (1x250 mg,oral) ]
5.Start Date: Nov/17/2020
6.Ongoing? NO
End Date:
Nov/19/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822491
Page 111 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [10]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[CLEXANE(ENOXAPARIN SODIUM 1x0.8 mg,subcutaneous) ]
5.Start Date: Nov/20/2020
6.Ongoing? YES
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822492
Page 112 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [11]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Teicoplanin (1x400 mg IV) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/29/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822493
Page 113 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [12]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Piperacillin - tazobactam (3x4.5 g/day IV) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/29/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822494
Page 114 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [13]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Tocilizumab (1x400 mg IV) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/22/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822495
Page 115 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [14]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Oxygen mask (12 L/MIN) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/21/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822496
Page 116 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [15]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Favipiravir(2x600 mg,oral) ]
5.Start Date: Nov/12/2020
6.Ongoing? NO
End Date:
Nov/15/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822497
Page 117 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [16]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Azithromycin(1x250 mg,oral) ]
5.Start Date: Nov/15/2020
6.Ongoing? NO
End Date:
Nov/16/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822498
Page 118 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [17]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Nasal Cannula oxygen (6 L/MIN) ]
5.Start Date: Nov/22/2020
6.Ongoing? NO
End Date:
Nov/28/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822499
Page 119 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [18]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Teicoplanin (loading dose,2x400 mg IV) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/20/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822500
Page 120 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [19]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Lansazol (lansoprazole, 30 mg, 1x1 oral) ]
5.Start Date: Nov/20/2020
6.Ongoing? YES
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822501
Page 121 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Concomitant Medications
1.What is the medication identifier? [20]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Seralin (sertralin, 50 mg, 1x1 oral) ]
5.Start Date: Nov/20/2020
6.Ongoing? NO
End Date:
Nov/29/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822502
Page 122 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Asse
ssmentLocation of As
sessmentImaging M
ethodOverall AssessmentForm Instanc
e
 1.Nov/14/2020
 CHEST  CT SCAN  ABNORMAL
If abnormal, specify findings:
Report result: COVID-19 category 2; prevalent peripheral grou
nd glass density of the bilateral lung.
 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822503
Page 123 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/14/2020 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: CT SCAN Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Report result: COVID-19 category 2; prevalent peripheral ground glass
density of the bilateral lung.]Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822504
Page 124 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/10/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822505
Page 125 of 622
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/10/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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/10/2020
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 [BR511S]
5.bSample ID [BR511T]
5.cSample ID [BS2S4T]
5.dSample ID [BS2S4V]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822506
Page 126 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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:
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822507
Page 127 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822508
Page 128 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identifie
rAdverse Eve
ntStart DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  Anxiety  Nov/21/2020 UNK:UN
K NO
End Date Time:
Mar/10/2021 UNK:UNK
 Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822509
Page 129 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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)[Anxiety]
4.Start Date Time: Nov/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/10/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[related to the covid-19 disease]
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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822510
Page 130 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822511
Page 131 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ongo
ingStudy Medication Errors Act
ionForm Instance
 1.          Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822512
Page 132 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822513
Page 133 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medicat
ionStart Dat
eForm Instanc
e
 1.1  VACCINATIONS  NO  Influenza vaccine  Dec/15/20
20 Repeating
Pages
 2.2  VACCINATIONS  NO  pneumococcal vac
cine Dec/15/20
20 Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822514
Page 134 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Influenza vaccine]
5.Date: Dec/15/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822515
Page 135 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[pneumococcal vaccine]
5.Date: Dec/15/2020
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822516
Page 136 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822517
Page 137 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
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).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822518
Page 138 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822519
Page 139 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822520
Page 140 of 622
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822521
Page 141 of 622
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822522
Page 142 of 622
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/03/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822523
Page 143 of 622
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/03/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822524
Page 144 of 622
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/03/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Dec/3/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822525
Page 145 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822526
Page 146 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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:
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822527
Page 147 of 622
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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?
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822528
Page 148 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822529
Page 149 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822530
Page 150 of 622
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822531
Page 151 of 622
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822532
Page 152 of 622
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822533
Page 153 of 622
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 [ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822534
Page 154 of 622
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/10/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Exclusion criterion 5]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822535
Page 155 of 622
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822536
Page 156 of 622
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822537
Page 157 of 622
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Mar/4/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [He withdrew from the study because he give up vaccinated.]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822538
Page 158 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822539
Page 159 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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 : Mar/4/2021 Comments
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822540
Page 160 of 622
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
[ ]
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822541
Page 161 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Mar/4/2021
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822542
Page 162 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822543
Page 163 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Sila Akhan  Approved Mar-12-2021 13:18:44 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0822544
Page 164 of 622
***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, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-04-2020 14:02:54 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822545
Page 165 of 622
***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, Locked, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-04-2020 14:03:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822546
Page 166 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822547
Page 167 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822548
Page 168 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822549
Page 169 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822550
Page 170 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822551
Page 171 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822552
Page 172 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822553
Page 173 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822554
Page 174 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822555
Page 175 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822556
Page 176 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822557
Page 177 of 622
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
11Dec-10-2020 19:08:34 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822558
Page 178 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-15-2021 15:14:56 (UTC+03:00) Istanbul The second vaccination could not administer to the
subject due to Covid-19 disease. So the second
vaccination diary did not completed.
FormJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
FormJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822559
Page 179 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
1Jan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822560
Page 180 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.aJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822561
Page 181 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.bJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.bJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822562
Page 182 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.cJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.cJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822563
Page 183 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.dJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.dJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822564
Page 184 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.eJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.eJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822565
Page 185 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 fJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2 fJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822566
Page 186 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.gJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2.gJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822567
Page 187 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2 hJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
2 hJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822568
Page 188 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
3Jan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822569
Page 189 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
4Jan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822570
Page 190 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
5.aJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822571
Page 191 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
5.bJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822572
Page 192 of 622
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-15-2021 13:30:29 (UTC+03:00) Istanbul Not Done
5.cJan-08-2021 12:59:33 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822573
Page 193 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-06-2021 15:33:13 (UTC+03:00) Istanbul “shortness of breath” is still ongoing, but “fever, new
or increased muscle pain, new loss of taste or smell
and sweating” were ended on 10 dec 2020.
3Jan-06-2021 15:19:46 (UTC+03:00) Istanbul subject symptoms ongoing
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822574
Page 194 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-19-2020 18:21:31 (UTC+03:00) Istanbul Binnur Yildirim Test was performed at the site.Lab name is Kocaeli
Universitesi Arastirma ve Uygulama Hsstanesi, Tibbi
Mikrobiyoloji Laboratuvari. The lab has Turkey's
Ministry of Health License. License no:438/03
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822575
Page 195 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Nov-24-2020 15:41:09 (UTC+03:00) Istanbul Test was performed at the site.Lab name is Kocaeli
Universitesi Arastirma ve Uygulama Hsstanesi, Tibbi
Mikrobiyoloji Laboratuvari. The lab has Turkey's
Ministry of Health License. License no:438/03
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822576
Page 196 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-18-2020 20:56:31 (UTC+03:00) Istanbul
FormNov-17-2020 15:08:35 (UTC+03:00) Istanbul Not Done
FormNov-16-2020 11:58:01 (UTC+03:00) Istanbul Not Applicable
FormNov-12-2020 17:09:03 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822577
Page 197 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-18-2020 20:56:31 (UTC+03:00) Istanbul
1Nov-17-2020 15:08:35 (UTC+03:00) Istanbul Not Done
1Nov-16-2020 11:58:01 (UTC+03:00) Istanbul Not Applicable
1Nov-12-2020 17:09:03 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822578
Page 198 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-18-2020 20:56:31 (UTC+03:00) Istanbul
2Nov-17-2020 15:08:35 (UTC+03:00) Istanbul Not Done
2Nov-16-2020 11:58:01 (UTC+03:00) Istanbul Not Applicable
2Nov-12-2020 17:09:03 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822579
Page 199 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-18-2020 20:56:31 (UTC+03:00) Istanbul
3Nov-17-2020 15:08:35 (UTC+03:00) Istanbul Not Done
3Nov-16-2020 11:58:01 (UTC+03:00) Istanbul Not Applicable
3Nov-12-2020 17:09:03 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822580
Page 200 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-18-2020 20:56:31 (UTC+03:00) Istanbul
4Nov-17-2020 15:08:35 (UTC+03:00) Istanbul Not Done
4Nov-16-2020 11:58:01 (UTC+03:00) Istanbul Not Applicable
4Nov-12-2020 17:09:03 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822581
Page 201 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-23-2020 15:43:28 (UTC+03:00) Istanbul Binnur Yildirim
3Nov-16-2020 16:35:12 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822582
Page 202 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-23-2020 15:43:46 (UTC+03:00) Istanbul Binnur Yildirim
5Nov-16-2020 16:35:27 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822583
Page 203 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-23-2020 15:44:18 (UTC+03:00) Istanbul Binnur Yildirim
6Nov-16-2020 16:35:38 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822584
Page 204 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-16-2020 12:02:26 (UTC+03:00) Istanbul
FormNov-13-2020 11:32:50 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822585
Page 205 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-16-2020 12:02:26 (UTC+03:00) Istanbul
1Nov-13-2020 11:32:50 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822586
Page 206 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-16-2020 12:02:26 (UTC+03:00) Istanbul
2Nov-13-2020 11:32:50 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822587
Page 207 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-16-2020 12:02:26 (UTC+03:00) Istanbul
3Nov-13-2020 11:32:50 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822588
Page 208 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormNov-26-2020 15:40:47 (UTC+03:00) Istanbul Not Applicable
FormNov-23-2020 15:53:57 (UTC+03:00) Istanbul Binnur Yildirim
FormNov-16-2020 16:47:25 (UTC+03:00) Istanbul Not Applicable
FormNov-16-2020 16:45:12 (UTC+03:00) Istanbul
FormNov-16-2020 16:31:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822589
Page 209 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Nov-26-2020 15:40:47 (UTC+03:00) Istanbul Not Applicable
1Nov-23-2020 15:53:57 (UTC+03:00) Istanbul Binnur Yildirim
1Nov-16-2020 16:47:25 (UTC+03:00) Istanbul Not Applicable
1Nov-16-2020 16:45:12 (UTC+03:00) Istanbul
1Nov-16-2020 16:31:11 (UTC+03:00) Istanbul Not Applicable
1Nov-16-2020 16:29:33 (UTC+03:00) Istanbul Not Applicable
1Nov-16-2020 12:05:49 (UTC+03:00) Istanbul
1Nov-13-2020 11:33:29 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (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)
(b) (4)
FDA-CBER-2021-5683-0822590
Page 210 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Nov-26-2020 15:40:47 (UTC+03:00) Istanbul Not Applicable
2Nov-23-2020 15:53:57 (UTC+03:00) Istanbul Binnur Yildirim
2Nov-16-2020 16:47:25 (UTC+03:00) Istanbul Not Applicable
2Nov-16-2020 16:45:12 (UTC+03:00) Istanbul
2Nov-16-2020 16:31:11 (UTC+03:00) Istanbul Not Applicable
2Nov-16-2020 16:30:55 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0822591
Page 211 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Nov-26-2020 15:40:47 (UTC+03:00) Istanbul Not Applicable
3Nov-23-2020 15:53:57 (UTC+03:00) Istanbul Binnur Yildirim
3Nov-16-2020 16:47:25 (UTC+03:00) Istanbul Not Applicable
3Nov-16-2020 16:45:12 (UTC+03:00) Istanbul
3Nov-16-2020 16:31:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822592
Page 212 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Nov-26-2020 15:40:47 (UTC+03:00) Istanbul Not Applicable
4Nov-23-2020 15:53:57 (UTC+03:00) Istanbul Binnur Yildirim
4Nov-16-2020 16:47:25 (UTC+03:00) Istanbul Not Applicable
4Nov-16-2020 16:45:12 (UTC+03:00) Istanbul
4Nov-16-2020 16:31:11 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822593
Page 213 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:28:02 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822594
Page 214 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:28:02 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822595
Page 215 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:28:02 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822596
Page 216 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aNov-17-2020 15:28:02 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822597
Page 217 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:26:47 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822598
Page 218 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:26:47 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822599
Page 219 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:26:47 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822600
Page 220 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jNov-17-2020 15:26:47 (UTC+03:00) Istanbul grade-1, related to covid-19
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822601
Page 221 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-23-2020 16:06:48 (UTC+03:00) Istanbul Binnur Yildirim
FormNov-17-2020 18:19:58 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822602
Page 222 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-23-2020 16:06:48 (UTC+03:00) Istanbul Binnur Yildirim
1Nov-17-2020 18:19:58 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822603
Page 223 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-23-2020 16:06:48 (UTC+03:00) Istanbul Binnur Yildirim
2Nov-17-2020 18:19:58 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822604
Page 224 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-23-2020 16:06:48 (UTC+03:00) Istanbul Binnur Yildirim
3Nov-17-2020 18:19:58 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0822605
Page 225 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormNov-16-2020 17:34:37 (UTC+03:00) Istanbul
FormNov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822606
Page 226 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
1Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822607
Page 227 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
2Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822608
Page 228 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
3Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822609
Page 229 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
4Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822610
Page 230 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
5Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822611
Page 231 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Nov-16-2020 17:34:37 (UTC+03:00) Istanbul
6Nov-13-2020 11:47:54 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822612
Page 232 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-16-2020 17:28:26 (UTC+03:00) Istanbul
FormNov-13-2020 11:47:27 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822613
Page 233 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-16-2020 17:28:26 (UTC+03:00) Istanbul
1Nov-13-2020 11:47:27 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822614
Page 234 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-16-2020 17:28:26 (UTC+03:00) Istanbul
2Nov-13-2020 11:47:27 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822615
Page 235 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-16-2020 17:28:26 (UTC+03:00) Istanbul
3Nov-13-2020 11:47:27 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822616
Page 236 of 622
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/12/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-16-2020 17:28:26 (UTC+03:00) Istanbul
4Nov-13-2020 11:47:27 (UTC+03:00) Istanbul Not Done
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822617
Page 237 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-06-2021 20:29:09 (UTC+03:00) Istanbul
FormJan-04-2021 14:20:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822618
Page 238 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-06-2021 20:29:09 (UTC+03:00) Istanbul
1Jan-04-2021 14:20:05 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822619
Page 239 of 622
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-04-2021 14:20:22 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822620
Page 240 of 622
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-04-2021 14:20:22 (UTC+03:00) Istanbul Not Applicable
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822621
Page 241 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 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
Sila Akhan  Approved Mar-12-2021 13:18:44 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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 Mar-12-2021 13:16:04 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Mar-12-2021 13:01:49 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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 Mar-12-2021 12:16:43 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Mar-06-2021 20:42:08 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822622
Page 242 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SilaAkhan, 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 Mar-06-2021 20:29:09 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Mar-05-2021 11:12:01 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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 Mar-05-2021 11:04:07 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Feb-16-2021 12:39:01 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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-16-2021 10:42:05 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822623
Page 243 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
N/A
Sila Akhan  Approved Jan-18-2021 14:41:56 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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-15-2021 13:30:29 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-13-2021 08:08:02 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
Binnur Yildirim  N/A Jan-11-2021 15:10:18 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-08-2021 13:08:17 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822624
Page 244 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 N/A Jan-08-2021 12:58:20 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-07-2021 15:55:32 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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-06-2021 15:19:12 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-05-2021 15:11:01 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, , 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-05-2021 13:56:02 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Jan-04-2021 14:55:02 (UTC+03:00) Istanbul BOOK Signed
090177e196ae2f28\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0822625
Page 245 of 622
***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: 1217 Site Name: (1217) Kocaeli University Faculty of Medicine
Subject No: 12171044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SilaAkhan, 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.
Binnur Yildirim  N/A Dec-29-2020 13:57:36 (UTC+03:00) Istanbul Edit - All
signatures
invalidated
Affidavit:
N/A
Sila Akhan  Approved Dec-16-2020 14:46:36 (UTC+03:00) Istanbul BOOK Signed
Affidavit:
By my dated signature below, I, SilaAkhan, 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 R
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