125742 S1 M5 CRF c4591001 1247 12471121

Document text

Page 1 of 436
***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: 12471121 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 COHORTS
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892795
Page 2 of 436
***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: 12471121 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/30/2020
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892796
Page 3 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471121]
2.Birth Date: UNK/UNK/2001
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892797
Page 4 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892798
Page 5 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 12471121 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 Criterion
MetNot Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892799
Page 6 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892800
Page 7 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892801
Page 8 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 POSITIVE
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892802
Page 9 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
2.Weight: [88.0]
3.Unit: kg
4.Height: [183.0]
5.Unit: cm
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892803
Page 10 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892804
Page 11 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/30/2020
2.Randomization Number: [102046]
3.Randomization Group: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892805
Page 12 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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/30/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CM6]
5.bSample ID [BRSF21]
5.cSample ID [BRSF22]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892806
Page 13 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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/30/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CLH]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892807
Page 14 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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: Sep/30/2020 11:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892808
Page 15 of 436
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 SUBJECT
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892809
Page 16 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892810
Page 17 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION 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: 12471121 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?YES
Ongoing?
NO
Stop Date:
Oct/6/2020
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/6/2020
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/6/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/6/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892811
Page 18 of 436
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Oct/6/2020
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892812
Page 19 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892813
Page 20 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/21/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892814
Page 21 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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/21/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9D1T]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892815
Page 22 of 436
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
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: 12471121 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: Oct/21/2020 10:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892816
Page 23 of 436
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892817
Page 24 of 436
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions present
on the last day the Subject Diary was
completed?
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892818
Page 25 of 436
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892819
Page 26 of 436
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892820
Page 27 of 436
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892821
Page 28 of 436
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892822
Page 29 of 436
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892823
Page 30 of 436
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892824
Page 31 of 436
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892825
Page 32 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892826
Page 33 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/5/2020
2.Date of First Symptom Started: Oct/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892827
Page 34 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locatio
nAssay Code and Descriptio
nDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892828
Page 35 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892829
Page 36 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: 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: 12471121 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:
Oct/5/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV24081]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892830
Page 37 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Only self swab done.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892831
Page 38 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892832
Page 39 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892833
Page 40 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892834
Page 41 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892835
Page 42 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892836
Page 43 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892837
Page 44 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Iden
tifierTest:Result:
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e 
Not Done  Not Don
e Not Don
e Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892838
Page 45 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892839
Page 46 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892840
Page 47 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892841
Page 48 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892842
Page 49 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892843
Page 50 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892844
Page 51 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892845
Page 52 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892846
Page 53 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892847
Page 54 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892848
Page 55 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892849
Page 56 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892850
Page 57 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892851
Page 58 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892852
Page 59 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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
[ ]Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892853
Page 60 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Done  Not Done  Not Done  Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892854
Page 61 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892855
Page 62 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892856
Page 63 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text (e.g.,
Ingredient(s), route, use, formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892857
Page 64 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892858
Page 65 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892859
Page 66 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892860
Page 67 of 436
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892861
Page 68 of 436
***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: 12471121 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:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892862
Page 69 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892863
Page 70 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/01/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892864
Page 71 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/01/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892865
Page 72 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/01/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/1/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Patient contacted 01, 02 and 05 Oct. Patient advised to do home swab 05 Oct - patient
symptoms were improving and patient was not limited in her activities]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892866
Page 73 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892867
Page 74 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892868
Page 75 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/02/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/2/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892869
Page 76 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Oct/05/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892870
Page 77 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Oct/05/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892871
Page 78 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Oct/05/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/5/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Pt. invited for consultation, pt. doesn't feel its necessary.]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892872
Page 79 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Oct/21/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892873
Page 80 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Oct/21/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892874
Page 81 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Oct/21/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/21/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892875
Page 82 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Oct/23/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892876
Page 83 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Oct/23/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892877
Page 84 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Oct/23/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/23/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892878
Page 85 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Oct/24/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/24/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892879
Page 86 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Oct/24/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892880
Page 87 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Oct/24/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/24/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892881
Page 88 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Oct/28/2020Form: 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892882
Page 89 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Oct/28/2020Form: UNPLANNED VISIT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892883
Page 90 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Oct/28/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/28/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892884
Page 91 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  Flail Chest  Oct/30/2020 UNK:UN
K YES  Repeating
Pages
 2.ADVERSE EVEN
T 2  Motorcyle accide
nt Oct/30/2020 UNK:UN
K NO
End Date Time:
Oct/30/2020 UNK:UNK
 Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892885
Page 92 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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)[Flail Chest]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Flail chest secondary to motorcycle accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892886
Page 93 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT 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[2020428199]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892887
Page 94 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Motorcyle accident]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Motorcycle accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892888
Page 95 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892889
Page 96 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication Er
rorStart DateIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.Not Applicab
le Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892890
Page 97 of 436
***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: 12471121 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
[ ]Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892891
Page 98 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892892
Page 99 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text (e.g.,
Ingredient(s), route, use, formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892893
Page 100 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892894
Page 101 of 436
***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: 12471121 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, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text (e.g.,
Ingredient(s), route, use, formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892895
Page 102 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatment Start Date Form Instance
 1.Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892896
Page 103 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892897
Page 104 of 436
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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 Pages
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892898
Page 105 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 12471121 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
//Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892899
Page 106 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Patient withdrew after motorcycle accident (Undisclosed medical condition)]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892900
Page 107 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892901
Page 108 of 436
***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: 12471121 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:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892902
Page 109 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892903
Page 110 of 436
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
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: 12471121 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 product
administration?
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892904
Page 111 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892905
Page 112 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892906
Page 113 of 436
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892907
Page 114 of 436
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892908
Page 115 of 436
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892909
Page 116 of 436
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892910
Page 117 of 436
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Patient withdrew after motorcycle accident (Undisclosed medical condition)]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892911
Page 118 of 436
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - 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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892912
Page 119 of 436
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892913
Page 120 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892914
Page 121 of 436
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Oct/30/2020
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892915
Page 122 of 436
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 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
[ ]
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892916
Page 123 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/30/2020
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892917
Page 124 of 436
***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: 12471121 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 Enable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892918
Page 125 of 436
***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: 12471121 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 Action
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0892919
Page 126 of 436
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-30-2020 17:59:12 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892920
Page 127 of 436
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-30-2020 17:59:47 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892921
Page 128 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892922
Page 129 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892923
Page 130 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892924
Page 131 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892925
Page 132 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892926
Page 133 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892927
Page 134 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892928
Page 135 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892929
Page 136 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892930
Page 137 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-20-2020 09:02:21 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892931
Page 138 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:02:38 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892932
Page 139 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 10:48:02 (UTC+02:00) Harare, Pretoria Haylene Nell Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892933
Page 140 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
FormOct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892934
Page 141 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
1Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892935
Page 142 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
2Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892936
Page 143 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
3Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892937
Page 144 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
4Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892938
Page 145 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
5Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892939
Page 146 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-20-2020 10:55:25 (UTC+02:00) Harare, Pretoria Haylene Nell Respiratory treatment is not applicable
Not Applicable
6Oct-20-2020 09:04:37 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892940
Page 147 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:55:58 (UTC+02:00) Harare, Pretoria Haylene Nell This is not applicable
Not Applicable
FormOct-20-2020 09:05:24 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892941
Page 148 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 10:55:58 (UTC+02:00) Harare, Pretoria Haylene Nell This is not applicable
Not Applicable
1Oct-20-2020 09:05:24 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892942
Page 149 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 10:55:58 (UTC+02:00) Harare, Pretoria Haylene Nell This is not applicable
Not Applicable
2Oct-20-2020 09:05:24 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892943
Page 150 of 436
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Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 10:55:58 (UTC+02:00) Harare, Pretoria Haylene Nell This is not applicable
Not Applicable
3Oct-20-2020 09:05:24 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892944
Page 151 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 10:55:58 (UTC+02:00) Harare, Pretoria Haylene Nell This is not applicable
Not Applicable
4Oct-20-2020 09:05:24 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892945
Page 152 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:56:50 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only
FormOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892946
Page 153 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892947
Page 154 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892948
Page 155 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892949
Page 156 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892950
Page 157 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892951
Page 158 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892952
Page 159 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892953
Page 160 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892954
Page 161 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892955
Page 162 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892956
Page 163 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892957
Page 164 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892958
Page 165 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892959
Page 166 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892960
Page 167 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892961
Page 168 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892962
Page 169 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892963
Page 170 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892964
Page 171 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892965
Page 172 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892966
Page 173 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892967
Page 174 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892968
Page 175 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892969
Page 176 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892970
Page 177 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892971
Page 178 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892972
Page 179 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892973
Page 180 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892974
Page 181 of 436
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892975
Page 182 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892976
Page 183 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892977
Page 184 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:05:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892978
Page 185 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:57:11 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only
FormOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0892979
Page 186 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892980
Page 187 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892981
Page 188 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892982
Page 189 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892983
Page 190 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892984
Page 191 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892985
Page 192 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892986
Page 193 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892987
Page 194 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892988
Page 195 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892989
Page 196 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892990
Page 197 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892991
Page 198 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892992
Page 199 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892993
Page 200 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892994
Page 201 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892995
Page 202 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892996
Page 203 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892997
Page 204 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892998
Page 205 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0892999
Page 206 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893000
Page 207 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893001
Page 208 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893002
Page 209 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893003
Page 210 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893004
Page 211 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893005
Page 212 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893006
Page 213 of 436
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893007
Page 214 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893008
Page 215 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893009
Page 216 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893010
Page 217 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893011
Page 218 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893012
Page 219 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893013
Page 220 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893014
Page 221 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893015
Page 222 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893016
Page 223 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893017
Page 224 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893018
Page 225 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893019
Page 226 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893020
Page 227 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893021
Page 228 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893022
Page 229 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-20-2020 09:06:03 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893023
Page 230 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:57:30 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only
FormOct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893024
Page 231 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893025
Page 232 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893026
Page 233 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893027
Page 234 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893028
Page 235 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 09:06:39 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893029
Page 236 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:57:53 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only
FormOct-20-2020 09:06:55 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893030
Page 237 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:06:55 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893031
Page 238 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-20-2020 09:06:55 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893032
Page 239 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:58:10 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only
FormOct-20-2020 09:07:12 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893033
Page 240 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:07:12 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893034
Page 241 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:07:12 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893035
Page 242 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:07:12 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893036
Page 243 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:58:33 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only and not indicated
FormOct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893037
Page 244 of 436
***Confidential***
Header Text: c4591001
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Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893038
Page 245 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893039
Page 246 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893040
Page 247 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893041
Page 248 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893042
Page 249 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-20-2020 09:07:27 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893043
Page 250 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-20-2020 10:58:56 (UTC+02:00) Harare, Pretoria Haylene Nell Not done - telephonic contact only and not indicated
FormOct-20-2020 09:07:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893044
Page 251 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-20-2020 09:07:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893045
Page 252 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-20-2020 09:07:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893046
Page 253 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-20-2020 09:07:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893047
Page 254 of 436
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-20-2020 09:07:44 (UTC+02:00) Harare, Pretoria Not Done
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893048
Page 255 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893049
Page 256 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893050
Page 257 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893051
Page 258 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893052
Page 259 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893053
Page 260 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893054
Page 261 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893055
Page 262 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893056
Page 263 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893057
Page 264 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893058
Page 265 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-13-2020 14:28:19 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893059
Page 266 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893060
Page 267 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893061
Page 268 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893062
Page 269 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893063
Page 270 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893064
Page 271 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-13-2020 14:28:35 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893065
Page 272 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893066
Page 273 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893067
Page 274 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893068
Page 275 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893069
Page 276 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893070
Page 277 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893071
Page 278 of 436
***Confidential***
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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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893072
Page 279 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893073
Page 280 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893074
Page 281 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893075
Page 282 of 436
***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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-13-2020 14:28:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893076
Page 283 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893077
Page 284 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893078
Page 285 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893079
Page 286 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893080
Page 287 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893081
Page 288 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893082
Page 289 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-13-2020 14:29:07 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893083
Page 290 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-13-2020 14:29:25 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893084
Page 291 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-13-2020 14:29:25 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893085
Page 292 of 436
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-13-2020 14:29:25 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893086
Page 293 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-08-2020 13:37:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893087
Page 294 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-08-2020 13:37:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893088
Page 295 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-08-2020 13:37:51 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893089
Page 296 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-08-2020 13:38:08 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893090
Page 297 of 436
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-08-2020 13:38:08 (UTC+02:00) Harare, Pretoria Not Applicable
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893091
Page 298 of 436
***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: 12471121 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-22-2021 11:59:55 (UTC+02:00) Harare, Pretoria Edit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell  Approved Jan-27-2021 16:38:27 (UTC+02:00) Harare, Pretoria BOOK Signed
Affidavit:
By my dated signature below, I, HayleneNell, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-19-2020 08:33:48 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell  Approved Nov-17-2020 12:35:50 (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 the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-13-2020 14:28:19 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2fc0\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893092
Page 299 of 436
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - 
…[truncated]