Document text
Page 1 of 471
***Confidential***Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 COHORTS090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892324
Page 2 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1. Consent Was: OBTAINED
Date Written Consent Obtained
Sep/29/2020090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892325
Page 3 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1. Subject ID [12471092]
2. Birth Date: UNK/UNK/1983
3. Sex: MALE
4. Ethnicity: NOT HISP ANIC OR LA
TINO(A) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
WHITE
6. Racial Designation:090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892326
Page 4 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Sep/29/2020
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892327
Page 5 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion CriterionMetNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892328
Page 6 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1. Date of Completion/Discontinuation
/DeathSep/29/2020
2. Phase of Disposition: SCREENING
3. Status: COMPLETED
4. Specify Status: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892329
Page 7 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/DrugAllergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892330
Page 8 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
HIV Status
1. Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892331
Page 9 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1. Date: Sep/29/2020
2. Weight: [99.0]
3. Unit: kg
4.Height: [167.0]
5.
Unit: cm
6. Body Mass Index: [35.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CA VITY090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892332
Page 10 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1. Randomization Date : Sep/29/2020
2. Randomization Number: [101646]
3. Randomization Group: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892333
Page 11 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or samplewas not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CK2]
5.bSample ID [BRSF03]
5.cSample ID [BRSF04]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892334
Page 12 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.
If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CJV]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892335
Page 13 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: S
ep/29/2020 09:49
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 OBSERV ATION PERIOD
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892336
Page 14 of 471
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1. Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892337
Page 15 of 471
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Oct/20/2020
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892338
Page 16 of 471
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 symptomspresent on the last day the SubjectDiary was completed?NO
2.bSymptom: FA
TIGUE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2fSymptom: DIARRHEA
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892339
Page 17 of 471
***Confidential***Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the SubjectDiary was completed?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892340
Page 18 of 471
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1. Date: Oct/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CA VITY090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892341
Page 19 of 471
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.
If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9FLN]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892342
Page 20 of 471
***Confidential***
Header Text: c4591001
Visit: V2_V AX2_L Form: V ACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1. Was there a temporary delay of
vaccination?YES
Date of First Delay:
Oct/20/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.
Formulation: INJECTION
4. Dose Date Time: Oct/29/2020 12:07
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 OBSERV ATION PERIOD
11. Was the subject observed for at least
the protocol specified observationperiod after investigational productadministration?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892343
Page 21 of 471
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Nov/26/2020
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892344
Page 22 of 471
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 symptomspresent on the last day the SubjectDiary was completed?NO
2.bSymptom: FA
TIGUE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2fSymptom: DIARRHEA
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptomspresent on the last day the SubjectDiary was completed?NO090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892345
Page 23 of 471
***Confidential***Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: V ACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the SubjectDiary was completed?NO
3. Injection Site Location: DELTOID MUSCLE
4. Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactionspresent on the last day the SubjectDiary was completed?NO090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892346
Page 24 of 471
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTV AX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Nov/26/2020
4.If no sample was collected or samplewas not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9FWL]
5.bSample ID [BR
Y9PC]
5.cSample ID [BRY9PD]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892347
Page 25 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Dec/23/2020
2. Erroneous V isit
COVID-19 Illness Visit
3.
COVID-19 Illness Visit: COVID_A090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892348
Page 26 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1. Date of Assessment: Dec/23/2020
2. Date of First Symptom Started: Dec/16/2020
3. Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/6/2021
Symptoms
4.aSymptoms: FEVER
Wa
s symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892349
Page 27 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.Symptoms - Other Text: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892350
Page 28 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/28/20
20 SWABBED MATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDROME CORONA VIRUS 2 SARS-COV-2 DIAGNOSTIC TEST
Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892351
Page 29 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1. Actual Date of Collection: Dec/28/2020 Comments
2. Specimen Type: SWABBED MATERIAL Comments
3. Specimen Collection Location: NASOPHARYNX Comments
4. Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONA VIRUS 2 Comments
5. Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6. Trade Name: OTHER Comments
7. Test Result: POSITIVE Comments
8. Comments/Findings/Details: [ ] Comments
9. Trade Name Other, Specify: [NALT Unknown] Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892352
Page 30 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
4.
If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV23909]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892353
Page 31 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB
3.Sample Collected? NO
4.
If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892354
Page 32 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or HealthcareProfessional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or HealthcareProfessional:PRIMAR Y CARE PHYSICIAN
Occurrence of V
isits or Contacts: YES
Number of Visits or Contacts:[1]
1.dPhysician or HealthcareProfessional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or HealthcareProfessional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1fPhysician or HealthcareProfessional: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?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892355
Page 33 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1. HOSPITALIZATION STATUS HOSPITAL Jan/2/2021 YES
Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892356
Page 34 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1. Hospitalization Category: HOSPITALIZATION STA T
US Comments
2. Hospitalization Term: HOSPITAL Comments
3. Admission Date: Jan/2/2021 Comments
4. Ongoing? YES Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892357
Page 35 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Jan/1/2021
Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892358
Page 36 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1. What is the treatment Identifier? [1] Comments
2. Concomitant Non-drug Treatment
Pre-specified:YES Comments
3. Treatment: HIGH FLOW OXYGEN THERAPY Comments
4. Treatment: [HIGH FLOW OXYGEN THERAPY] Comments
5. Start Date: Jan/1/2021 Comments
6. Ongoing? NO
End Date:
Jan/3/2021Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892359
Page 37 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1. Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2. Wa s a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Covid-19]
Date of Diagnosis:
Dec/28/2020
3.
Toxicity Grade: 1090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892360
Page 38 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892361
Page 39 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1. Category of Clinical Event: Not Applicable Comments
2. Subcategory of Clinical Event: Not Applicable Comments
3. Was a diagnosis obtained? Not Applicable Comments
4. Toxicity Grade: Not Applicable Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892362
Page 40 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.CLINICAL CHE
MISTRY National Health Laboratory Service Jan/1/2021 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
329 Not D
one 205
30 Not D
one 478
28 Not D
one 157
35 Not D
one 190
21 Not D
one 1.11
47 Not D
one
48 Not D
one 0.95 Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892363
Page 41 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1. Lab Panel: CLINICAL CHEMISTRY Comments
2. Laboratory Name and Address [National Health Laboratory Service] Comments
3. Collection Date: Jan/1/2021 Comments
4. Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [205] Comments
Not Done: Comments
LNMT Low
[0]High[10]Unitmg/LComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [478] Comments
Not Done: Comments
LNMT Low[10]High[40]UnitU/LComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892364
Page 42 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [157] Comments
Not Done: Comments
LNMT Low
[15]High[40]UnitU/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [190] Comments
Not Done: Comments
LNMT Low[40]High[120]UnitU/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Resul t
: [1.11] Comments
Not Done: Comments
LNMT Low[0.29]High[1.23]Unitmg/dLComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892365
Page 43 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]High[ ]UnitComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [0.95] Comments
Not Done: Comments
LNMT Low[0.72]High[1.18]Unitmg/dLComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892366
Page 44 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERI
VED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.HEMATOLOG
Y National Health Laboratory Service Jan/1/2021 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
1 Not D
one 13.8
2 Not D
one 0.418
3 Not D
one
5 Not D
one 405
7 Not D
one
608 Not D
one 9.36
609 Not D
one 0.07
612 Not D
one 0.38
610 Not D
one 0.03
611 Not D
one 1.27 Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892367
Page 45 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1. Lab Panel: HEMATOLOGY Comments
2. Laboratory Name and Address [National Health Laboratory Service] Comments
3. Collection Date: Jan/1/2021 Comments
4. Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [13.8] Comments
Not Done: Comments
LNMT Low
[13.0]High[17.0]Unitg/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [0.418] Comments
Not Done: Comments
LNMT Low[0.400]High[0.500]UnitL/LComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892368
Page 46 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]High[ ]UnitComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [405] Comments
Not Done: Comments
LNMT Low[171]High[388]Unit10^9/LComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low[ ]High[ ]UnitComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892369
Page 47 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [9.36] Comments
Not Done: Comments
LNMT Low
[1.60]High[6.98]Unit10^9/LComments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [0.07] Comments
Not Done: Comments
LNMT Low[0.00]High[0.95]Unit10^9/LComments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [0.38] Comments
Not Done: Comments
LNMT Low[0.30]High[0.80]Unit10^9/LComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892370
Page 48 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [0.03] Comments
Not Done: Comments
LNMT Low
[0.00]High[0.10]Unit10^9/LComments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [1.27] Comments
Not Done: Comments
LNMT Low[1.40]High[4.20]Unit10^9/LComments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892371
Page 49 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1. Jan/1/2021 Record Identifier: Systolic: Diastolic:
Not Done 158 100 Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892372
Page 50 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1. Date: Jan/1/2021 Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [158] Comments
Diastolic: [100] Comments
Respiratory Rate in
respirations/minute:[32] Comments
Heart Rate in beats/minute: [97] Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892373
Page 51 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1. Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892374
Page 52 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1. Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892375
Page 53 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Not Applicable Not Applicable Not Applicable
Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892376
Page 54 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1. Date Time of Assessment: Not Applicable
//Comments
2. Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3. FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892377
Page 55 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892378
Page 56 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1. What is the medication identifier? Not Applicable
[ ]Comments
2. Category: Not Applicable Comments
3. Concomitant Medications
Pre-specified:Not Applicable Comments
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name isunknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,formulation).Not Applicable
[ ]
Comments
5. Start Date: Not Applicable
//Comments
6. Ongoing? Not Applicable Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892379
Page 57 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessme
ntLocation of Assessme
ntImaging Metho
dOverall Assessment Form Instance
1.Jan/1/2021 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
Bilateral patchy ground glass infiltra
tes
Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892380
Page 58 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1. Date of Assessment: Jan/1/2021 Comments
2. Location of Assessment: CHEST Comments
3. Type of Imaging Exam: X-RAY Comments
4. Assessment: ABNORMAL
If abnormal, specify findings:
[Bilateral patchy ground glass infiltrates]Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892381
Page 59 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONV A 1 - Unscheduled
Visit on Jan/20/2021Form: DATE OF VISIT - ILLNESS CONV ALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Jan/20/2021
2. Erroneous V isit
COVID-19 Illness Visit
3.
COVID-19 Illness Visit: COVID_A1090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892382
Page 60 of 471
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONV A 1 - Unscheduled
Visit on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Jan/20/2021
4.If no sample was collected or samplewas not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7MTT]
5.bSample ID [BR
Y9VR]
5.cSample ID [BRY9VS]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892383
Page 61 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit
COVID-19 Repeat Swab
3. COVID-19 Repeat Swab:090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892384
Page 62 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1. Data Origin
2. Sample Type3. 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 [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892385
Page 63 of 471
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892386
Page 64 of 471
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1. Assessments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892387
Page 65 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Identifi
erAdverse Even
tStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Acute E.coli U
TI Oct/18/2020 UNK:UNK NO
End Date Time:
Oct/25/2020 UNK:UNK
Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892388
Page 66 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Acute E.coli UTI]
4. Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing?
NO
End Date Time:Oct/25/2020 UNK:UNK
6. Toxicity Grade: 2
7. Is the adverse event serious?
If Yes, NOTIFY PFIZERIMMEDIATELY .
Fatal; Life-threatening; Inpatient
hospitalization or prolongation ofexisting hospitalization; Persistent orsignificant disability/incapacity;Congenital anomaly/birth defect;Important medical event (i.e. mayjeopardize subject and may requiremedical/surgical intervention toprevent above outcomes).NO
8. Is this adverse event the result of a
study Medication Error?If Yes, record the type of medicationerror 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:[E.coli]
10. Latest Action Taken with Study
Treatment:NOT APPLICABLE
11. Was a Concomitant Medication
given?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892389
Page 67 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12. Was a Non-Drug Treatment given? NO
13. What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14. Did the adverse event cause the
subject to be discontinued from the
study?NO
15. Serious Adverse Event Number: For
Pfizer Use Only[ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892390
Page 68 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1.Not Applica
ble Not Applicable Not Applicable Not Applicable Not Applicable
Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892391
Page 69 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1. Category: Not Applicable Comments
2. Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3. Start Date: Not Applicable
//Comments
4. Is the medication error still ongoing? Not Applicable Comments
5. Latest Action Taken with Study
Treatment:Not Applicable Comments
6. Was a Concomitant Medication
given?Not Applicable Comments
7. Was a Non-Drug Treatment given? Not Applicable Comments
8. Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9. Was this medication error associated
with any adverse events?Not Applicable Comments
10. Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892392
Page 70 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892393
Page 71 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1. What is the medication identifier? Not Applicable
[ ]Comments
2. Category: Not Applicable Comments
3. Concomitant Medications
Pre-specified:Not Applicable Comments
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name isunknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,formulation).Not Applicable
[ ]
Comments
5. Date: Not Applicable
//Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892394
Page 72 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applica
ble Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892395
Page 73 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1. What is the medication identifier? Not Applicable
[ ]Comments
2. Category: Not Applicable Comments
3. Concomitant Medications
Pre-specified:Not Applicable Comments
4. Medication:
Provide the complete generic drug
name (including salt form, whereapplicable). Where generic name isunknown, enter the full trade orproprietary name. Include clarifyinginformation in the Medication text(e.g., Ingredient(s), route, use,formulation).Not Applicable
[ ]
Comments
5. Dose: Not Applicable[ ] Comments
6. Dose Unit: Not Applicable Comments
7. Dose Frequency: Not Applicable Comments
8. Route: Not Applicable Comments
9. Start Date: Not Applicable
//Comments
10. Ongoing? Not Applicable Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892396
Page 74 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryTreatment Identif
ierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicable
Repeating
Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892397
Page 75 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1. Category: Not Applicable Comments
2. What is the treatment Identifier? Not Applicable
[ ]Comments
3. Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4. Treatment: Not Applicable
[ ]Comments
5. Start Date: Not Applicable
//Comments
6. Ongoing? Not Applicable Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892398
Page 76 of 471
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Not Applicable Not Applicable
Repeating Pages090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892399
Page 77 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1. Transfusion Type: Not Applicable Comments
2. Date of Transfusion: Not Applicable
//Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892400
Page 78 of 471
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1. Date of Completion/Discontinuation
/Death :Nov/26/2020
2. Phase of Disposition: V ACCINAT ION
3.
Status: COMPLETED
4. Specify Status: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892401
Page 79 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892402
Page 80 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1. Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:Temperature Location:090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892403
Page 81 of 471
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 productadministration?090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892404
Page 82 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892405
Page 83 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892406
Page 84 of 471
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1. Date of Completion/Discontinuation
/Death ://
2. Phase of Disposition:
3. Status:4. Specify Status: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892407
Page 85 of 471
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Jan/31/2021
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892408
Page 86 of 471
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER V ACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1. Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:eligible per other protocol allowance(s) and confirmed to have received onlyplacebo at Vaccination 1/2090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892409
Page 87 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1. Date Treatment Unblinded : Feb/2/2021
2. Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL V
ACCINATION090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892410
Page 88 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1. Withdrawal of Consent Date : Not Applicable
//Comments090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892411
Page 89 of 471
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
[ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892412
Page 90 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Feb/4/2021
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892413
Page 91 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: INFORMED CONSENT - FURTHER V ACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1. Consent Was: OBTAINED
Date Written Consent Obtained
Feb/4/2021090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892414
Page 92 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
V ACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion CriterionMetNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892415
Page 93 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: DISPOSITION - SCREENING FOR FURTHER V ACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1. Date of Completion/Discontinuation
/Death :Feb/4/2021
2. Phase of Disposition: REPEAT SCREENING 1
3. Status: COMPLETED
4.Specify Status: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892416
Page 94 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type SERUM
3. Sample Collected? YES
Date of Collection:
Feb/4/2021
4.If no sample was collected or samplewas not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKR19]
5.bSample ID [BR
Y9YD]
5.cSample ID [BRY9YF]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892417
Page 95 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
4.
If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKR1X]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892418
Page 96 of 471
***Confidential***
Header Text: c4591001
Visit: V101_V AX3 Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1. Was there a temporary delay of
vaccination?NO
2. Treatment Name [BNT162b2]
3. Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 11:19
5.
Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [30.0]
9. Unit: ug
10. Timeframe Subject Was Observed 30 MINUTES
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892419
Page 97 of 471
***Confidential***
Header Text: c4591001
Visit: V102_V AX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1. Date of Visit Feb/25/2021
2. Erroneous V isit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892420
Page 98 of 471
***Confidential***
Header Text: c4591001
Visit: V102_V AX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1. Data Origin SITE
2. Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.
If no sample was collected or sample
was not collected according toprotocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKR8B]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892421
Page 99 of 471
***Confidential***
Header Text: c4591001
Visit: V102_V AX4 Form: V ACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1. Was there a temporary delay of
vaccination?NO
2. Treatment Name [BNT162b2]
3. Formulation: INJECTION
4.Dose Date Time: F
eb/25/2021 14:54
5. Anatomical Location: DELTOID MUSCLE
6. Body Side: LEFT
7. Route: INTRAMUSCULAR
8. Actual Dose: [30.0]
9. Unit: ug
10. Timeframe Subject Was Observed 30 MINUTES
11. Was the subject observed for at least
the protocol specified observation
period after investigational productadministration?YES090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892422
Page 100 of 471
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892423
Page 101 of 471
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892424
Page 102 of 471
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892425
Page 103 of 471
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892426
Page 104 of 471
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1. Date of Visit //
2. Erroneous Visit090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892427
Page 105 of 471
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1. Contact Type:
2. Was contact made?3. Comments: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892428
Page 106 of 471
***Confidential***
Header Text: c4591001
Visit: FURTHER_V ACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1. Date of Completion/Discontinuation
/Death ://
2. Phase of Disposition:
3. Status:4. Specify Status: [ ]090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892429
Page 107 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1. Subject Status FOLLOW-UP
2. Subject Status Date Nov/26/2020090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892430
Page 108 of 471
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1. Casebook Signature Click Here to Enable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892431
Page 109 of 471
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4)
FDA-CBER-2021-5683-0892432
Page 110 of 471
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Sep-29-2020 13:37:49 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892433
Page 111 of 471
***Confidential***Header Text: c4591001
Visit: V1_DAY1_V AX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Sep-29-2020 13:38:30 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892434
Page 112 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
Form Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
Form Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892435
Page 113 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
1 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
1 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892436
Page 114 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
2 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
2 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892437
Page 115 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
3 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
3 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892438
Page 116 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
4 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
4 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892439
Page 117 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
5 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
5 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892440
Page 118 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
6 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
6 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892441
Page 119 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
7 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
7 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
7 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892442
Page 120 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
8 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
8 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
8 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892443
Page 121 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
9 Dec-29-2020 15:26:41 (UTC+02:00) Harare,
Pretoria
9 Dec-29-2020 11:09:30 (UTC+02:00) Harare,
PretoriaPt planned to go on 26 Dec 2020, but clinic was
too full. Pt planned to go again on 28 Dec 2020;unknown at this stage if pt did go
Not Done
9 Dec-23-2020 12:40:36 (UTC+02:00) Harare,
PretoriaUnknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892444
Page 122 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-05-2021 07:55:47 (UTC+02:00) Harare,
Pretoria
Form Jan-02-2021 14:16:51 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes
Unknown
Form Jan-02-2021 14:16:34 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892445
Page 123 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-05-2021 07:55:47 (UTC+02:00) Harare,
Pretoria
1 Jan-02-2021 14:16:51 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes
Unknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892446
Page 124 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Jan-05-2021 07:55:47 (UTC+02:00) Harare,
Pretoria
2 Jan-02-2021 14:16:51 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes
Unknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892447
Page 125 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Jan-05-2021 07:55:47 (UTC+02:00) Harare,
Pretoria
3 Jan-02-2021 14:16:51 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes
Unknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892448
Page 126 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Jan-05-2021 07:55:47 (UTC+02:00) Harare,
Pretoria
4 Jan-02-2021 14:16:51 (UTC+02:00) Harare,
PretoriaPage to be updated when site receives hospital
notes
Unknown090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892449
Page 127 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
Form Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892450
Page 128 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
1 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892451
Page 129 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
2 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892452
Page 130 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
3 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892453
Page 131 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
4 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892454
Page 132 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
5 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892455
Page 133 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Jan-22-2021 11:57:02 (UTC+02:00) Harare,
Pretoria
6 Dec-23-2020 12:41:38 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892456
Page 134 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Dec-23-2020 12:42:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892457
Page 135 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Dec-23-2020 12:42:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892458
Page 136 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Dec-23-2020 12:42:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892459
Page 137 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Dec-23-2020 12:42:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892460
Page 138 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Dec-23-2020 12:42:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892461
Page 139 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
Form Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892462
Page 140 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
1 Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892463
Page 141 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
2 Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892464
Page 142 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
3 Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892465
Page 143 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
4 Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892466
Page 144 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892467
Page 145 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892468
Page 146 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892469
Page 147 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892470
Page 148 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892471
Page 149 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892472
Page 150 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892473
Page 151 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892474
Page 152 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892475
Page 153 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892476
Page 154 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892477
Page 155 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892478
Page 156 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892479
Page 157 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892480
Page 158 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892481
Page 159 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892482
Page 160 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892483
Page 161 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892484
Page 162 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892485
Page 163 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892486
Page 164 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892487
Page 165 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892488
Page 166 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892489
Page 167 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892490
Page 168 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892491
Page 169 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892492
Page 170 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892493
Page 171 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:19:55 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:15 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892494
Page 172 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
Form Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892495
Page 173 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
1 Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892496
Page 174 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
2 Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892497
Page 175 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
3 Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892498
Page 176 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
4 Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892499
Page 177 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892500
Page 178 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892501
Page 179 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892502
Page 180 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.a Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.a Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892503
Page 181 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892504
Page 182 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892505
Page 183 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892506
Page 184 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.b Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.b Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892507
Page 185 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892508
Page 186 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892509
Page 187 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892510
Page 188 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.c Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.c Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892511
Page 189 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892512
Page 190 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892513
Page 191 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892514
Page 192 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.d Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.d Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892515
Page 193 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892516
Page 194 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892517
Page 195 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892518
Page 196 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.e Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.e Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892519
Page 197 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892520
Page 198 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892521
Page 199 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892522
Page 200 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 f Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 f Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892523
Page 201 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892524
Page 202 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892525
Page 203 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892526
Page 204 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.g Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.g Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892527
Page 205 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 h Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 h Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892528
Page 206 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 h Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 h Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892529
Page 207 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 h Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 h Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892530
Page 208 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 h Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5 h Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892531
Page 209 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.i Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.i Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892532
Page 210 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.i Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.i Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892533
Page 211 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.i Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.i Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892534
Page 212 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.i Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.i Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892535
Page 213 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.j Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.j Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892536
Page 214 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.j Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.j Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892537
Page 215 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.j Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.j Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892538
Page 216 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5.j Jan-22-2021 11:52:09 (UTC+02:00) Harare,
Pretoria
5.j Dec-23-2020 12:43:36 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892539
Page 217 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
Form Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892540
Page 218 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
1 Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892541
Page 219 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2.a Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
2.a Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892542
Page 220 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2.a Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
2.a Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892543
Page 221 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2.a Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
2.a Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892544
Page 222 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2.a Jan-22-2021 11:18:46 (UTC+02:00) Harare,
Pretoria
2.a Dec-23-2020 12:44:01 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892545
Page 223 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Dec-23-2020 12:44:32 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892546
Page 224 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Dec-23-2020 12:44:32 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892547
Page 225 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2.a Dec-23-2020 12:44:32 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892548
Page 226 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Dec-23-2020 12:44:51 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892549
Page 227 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Dec-23-2020 12:44:51 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892550
Page 228 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Dec-23-2020 12:44:51 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892551
Page 229 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Dec-23-2020 12:44:51 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892552
Page 230 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892553
Page 231 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892554
Page 232 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892555
Page 233 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892556
Page 234 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892557
Page 235 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892558
Page 236 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: CONCOMITANT MEDICATIONS - V ASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Dec-23-2020 12:45:10 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892559
Page 237 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Jan-22-2021 12:15:42 (UTC+02:00) Harare,
Pretoria
Form Dec-23-2020 12:45:35 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892560
Page 238 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Jan-22-2021 12:15:42 (UTC+02:00) Harare,
Pretoria
1 Dec-23-2020 12:45:35 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892561
Page 239 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Jan-22-2021 12:15:42 (UTC+02:00) Harare,
Pretoria
2 Dec-23-2020 12:45:35 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892562
Page 240 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Jan-22-2021 12:15:42 (UTC+02:00) Harare,
Pretoria
3 Dec-23-2020 12:45:35 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892563
Page 241 of 471
***Confidential***Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/23/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Jan-22-2021 12:15:42 (UTC+02:00) Harare,
Pretoria
4 Dec-23-2020 12:45:35 (UTC+02:00) Harare,
PretoriaNot Done090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892564
Page 242 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892565
Page 243 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892566
Page 244 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892567
Page 245 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892568
Page 246 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892569
Page 247 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892570
Page 248 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892571
Page 249 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
7 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892572
Page 250 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
8 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892573
Page 251 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
9 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892574
Page 252 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
10 Oct-20-2020 11:25:11 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892575
Page 253 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892576
Page 254 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892577
Page 255 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892578
Page 256 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892579
Page 257 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892580
Page 258 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
V ACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Oct-20-2020 11:25:56 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892581
Page 259 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892582
Page 260 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892583
Page 261 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892584
Page 262 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892585
Page 263 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892586
Page 264 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892587
Page 265 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892588
Page 266 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
7 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892589
Page 267 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
8 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892590
Page 268 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
9 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892591
Page 269 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
10 Oct-20-2020 11:26:17 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892592
Page 270 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892593
Page 271 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892594
Page 272 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892595
Page 273 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
3 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892596
Page 274 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
4 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892597
Page 275 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
5 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892598
Page 276 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
6 Oct-20-2020 11:26:33 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892599
Page 277 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Oct-20-2020 11:26:52 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892600
Page 278 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Oct-20-2020 11:26:52 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892601
Page 279 of 471
***Confidential***Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
2 Oct-20-2020 11:26:52 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892602
Page 280 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Feb-25-2021 22:30:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892603
Page 281 of 471
***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Feb-25-2021 22:30:54 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892604
Page 282 of 471
***Confidential***Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Feb-25-2021 22:31:18 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892605
Page 283 of 471
***Confidential***Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
1 Feb-25-2021 22:31:18 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892606
Page 284 of 471
***Confidential***Header Text: c4591001
Visit: V101_V AX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
V ACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Item Date User Comment
Form Feb-04-2021 13:53:13 (UTC+02:00) Harare,
PretoriaNot Applicable090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892607
Page 285 of 471
***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, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-01-2021 10:26:25 (UTC+02:00) Harare,
PretoriaEdit - All
signaturesinvalidated
Affidavit:N/A
Haylene Nell Approved Jan-27-2021 15:22:43 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:By my dated signature below, I, HayleneNell, verify that all case report form pages accurately display the results of theexaminations, 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 electroni c
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 Nov-26-2020 10:22:14 (UTC+02:00) Harare,
PretoriaEdit - All
signaturesinvalidated
Affidavit:N/A
Haylene Nell Approved Nov-12-2020 14:38:51 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:By my dated signature below, I, HayleneNell, verify that all case report form pages accurately display the results of theexaminations, 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 electroni c
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.090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0892608
Page 286 of 471
***Confidential***Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-29-2020 13:34:52
(UTC+02:00) Harare,PretoriaACV0PFEINFP6000
Data Entry:08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-29-2020 13:34:52
(UTC+02:00) Harare,PretoriaACV0PFEINFP6000
Data Entry:STAGE 3 COHORTSInitial Entry090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0892609
Page 287 of 471
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-29-2020 13:35:07
(UTC+02:00) Harare,PretoriaACV0PFEINFP6000
Data Entry:OBTAINED
Date Written Consent Obtained
Sep/29/2020Initial Entry090177e196ae2fc3\Final\Final On: 01-A pr-2021 03:51 (GMT )
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0892610
Page 288 of 471
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471092 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-29-2020 13:33:18
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000
…[truncated]