Document text
Page 1 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894011
Page 2 of 425
***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: 12471220 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
Oct/8/2020
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894012
Page 3 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471220]
2.Birth Date: UNK/UNK/1976
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:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894013
Page 4 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894014
Page 5 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894015
Page 6 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894016
Page 7 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Temporal lobe Epilepsy]
Start Date: UNK/UNK/2001
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral tubal ligation Sterilized]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894017
Page 8 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894018
Page 9 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
2.Weight: [109.0]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [40.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894019
Page 10 of 425
***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: 12471220 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/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894020
Page 11 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/8/2020
2.Randomization Number: [104594]
3.Randomization Group: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894021
Page 12 of 425
***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: 12471220 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:
Oct/8/2020
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 [BM9CV8]
5.bSample ID [BRSTG2]
5.cSample ID [BRSTG5]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894022
Page 13 of 425
***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: 12471220 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/8/2020
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 [BM9CV2]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894023
Page 14 of 425
***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: 12471220 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/8/2020 09:38
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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894024
Page 15 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894025
Page 16 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894026
Page 17 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894027
Page 18 of 425
***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: 12471220 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/28/2020
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:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894028
Page 19 of 425
***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: 12471220 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/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9FKT]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894029
Page 20 of 425
***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: 12471220 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/28/2020 11:09
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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894030
Page 21 of 425
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894031
Page 22 of 425
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BR7MSB]
5.bSample ID [BRY9S5]
5.cSample ID [BRY9S6]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894032
Page 23 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894033
Page 24 of 425
***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: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894034
Page 25 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894035
Page 26 of 425
***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: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894036
Page 27 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894037
Page 28 of 425
***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: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894038
Page 29 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: 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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894039
Page 30 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/24/2020
2.Date of First Symptom Started: Dec/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894040
Page 31 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894041
Page 32 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894042
Page 33 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894043
Page 34 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: 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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/24/2020
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 [CV48884]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894044
Page 35 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: 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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Self-swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894045
Page 36 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894046
Page 37 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894047
Page 38 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894048
Page 39 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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?YES
Respiratory Illness Diagnosis:
[Pharyngitis]
Date of Diagnosis:
Dec/24/2020
3.Toxicity Grade: 1
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894049
Page 40 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894050
Page 41 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894051
Page 42 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab 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 Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894052
Page 43 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894053
Page 44 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894054
Page 45 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894055
Page 46 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894056
Page 47 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894057
Page 48 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894058
Page 49 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894059
Page 50 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894060
Page 51 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894061
Page 52 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894062
Page 53 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894063
Page 54 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894064
Page 55 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894065
Page 56 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894066
Page 57 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894067
Page 58 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894068
Page 59 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894069
Page 60 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894070
Page 61 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894071
Page 62 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894072
Page 63 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894073
Page 64 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/21/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894074
Page 65 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7MTD]
5.bSample ID [BRY9VT]
5.cSample ID [BRY9VV]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894075
Page 66 of 425
***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: 12471220 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:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894076
Page 67 of 425
***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: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894077
Page 68 of 425
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/30/2020Form: 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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894078
Page 69 of 425
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/30/2020Form: 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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894079
Page 70 of 425
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/30/2020Form: 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: 12471220 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/30/2020
Contact Outcome:
VISIT NOT REQUIRED, DATA ENTRY ERROR IN E-DIARY
3.Comments: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894080
Page 71 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Diarrhea Oct/9/2020 UNK:
UNK NO
End Date Time:
Oct/10/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Headaches Oct/29/2020 UNK
:UNK NO
End Date Time:
Oct/29/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Generalized Joint pain Oct/29/2020 UNK
:UNK NO
End Date Time:
Oct/29/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Left axillary lymphade
nopathy Oct/29/2020 UNK
:UNK NO
End Date Time:
Nov/2/2020 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Generalized Joint pain Oct/30/2020 UNK
:UNK YES Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894081
Page 72 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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)[Diarrhea]
4.Start Date Time: Oct/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/10/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894082
Page 73 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894083
Page 74 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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)[Headaches]
4.Start Date Time: Oct/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894084
Page 75 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894085
Page 76 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Generalized Joint pain]
4.Start Date Time: Oct/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894086
Page 77 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894087
Page 78 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left axillary lymphadenopathy]
4.Start Date Time: Oct/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/2/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894088
Page 79 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894089
Page 80 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Generalized Joint pain] Comments
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894090
Page 81 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894091
Page 82 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894092
Page 83 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894093
Page 84 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894094
Page 85 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894095
Page 86 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applica
ble Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894096
Page 87 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894097
Page 88 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
1.Not Applicab
le Not Applicable Not Applicable Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894098
Page 89 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894099
Page 90 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894100
Page 91 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894101
Page 92 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894102
Page 93 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894103
Page 94 of 425
***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: 12471220 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:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894104
Page 95 of 425
***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: 12471220 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:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894105
Page 96 of 425
***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: 12471220 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?
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894106
Page 97 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894107
Page 98 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894108
Page 99 of 425
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894109
Page 100 of 425
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894110
Page 101 of 425
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894111
Page 102 of 425
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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 [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894112
Page 103 of 425
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894113
Page 104 of 425
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894114
Page 105 of 425
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894115
Page 106 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894116
Page 107 of 425
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894117
Page 108 of 425
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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
[ ]
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894118
Page 109 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/30/2020
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894119
Page 110 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894120
Page 111 of 425
***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: 12471220 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
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894121
Page 112 of 425
***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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-08-2020 12:51:40 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894122
Page 113 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894123
Page 114 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894124
Page 115 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894125
Page 116 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894126
Page 117 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894127
Page 118 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894128
Page 119 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894129
Page 120 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894130
Page 121 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894131
Page 122 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-24-2020 13:57:33 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894132
Page 123 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894133
Page 124 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894134
Page 125 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894135
Page 126 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894136
Page 127 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894137
Page 128 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894138
Page 129 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-24-2020 14:00:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894139
Page 130 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:00:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894140
Page 131 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:00:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894141
Page 132 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:00:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894142
Page 133 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:00:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894143
Page 134 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:00:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894144
Page 135 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894145
Page 136 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894146
Page 137 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894147
Page 138 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894148
Page 139 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894149
Page 140 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894150
Page 141 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894151
Page 142 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894152
Page 143 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894153
Page 144 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894154
Page 145 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894155
Page 146 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894156
Page 147 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894157
Page 148 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894158
Page 149 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894159
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Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894160
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894161
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894162
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894163
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894164
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894165
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894166
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894167
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894168
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894169
Page 160 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894170
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894171
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894172
Page 163 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894173
Page 164 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894174
Page 165 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894175
Page 166 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894176
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:02 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894177
Page 168 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894178
Page 169 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894179
Page 170 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894180
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894181
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894182
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894183
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894184
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894185
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894186
Page 177 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894187
Page 178 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894188
Page 179 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894189
Page 180 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894190
Page 181 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894191
Page 182 of 425
***Confidential***
Header Text: c4591001
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on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894192
Page 183 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894193
Page 184 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894194
Page 185 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894195
Page 186 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894196
Page 187 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894197
Page 188 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894198
Page 189 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894199
Page 190 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894200
Page 191 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894201
Page 192 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894202
Page 193 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894203
Page 194 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894204
Page 195 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894205
Page 196 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894206
Page 197 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894207
Page 198 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894208
Page 199 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894209
Page 200 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894210
Page 201 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894211
Page 202 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894212
Page 203 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894213
Page 204 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894214
Page 205 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894215
Page 206 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894216
Page 207 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894217
Page 208 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894218
Page 209 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894219
Page 210 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894220
Page 211 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894221
Page 212 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jDec-24-2020 14:01:45 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894222
Page 213 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894223
Page 214 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894224
Page 215 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894225
Page 216 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894226
Page 217 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894227
Page 218 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-24-2020 14:02:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894228
Page 219 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:02:41 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894229
Page 220 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:02:41 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894230
Page 221 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aDec-24-2020 14:02:41 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894231
Page 222 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:03:18 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894232
Page 223 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:03:18 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894233
Page 224 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:03:18 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894234
Page 225 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:03:18 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894235
Page 226 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894236
Page 227 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894237
Page 228 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894238
Page 229 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894239
Page 230 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894240
Page 231 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894241
Page 232 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-24-2020 14:03:57 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894242
Page 233 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-24-2020 14:04:20 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894243
Page 234 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-24-2020 14:04:20 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894244
Page 235 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-24-2020 14:04:20 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894245
Page 236 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-24-2020 14:04:20 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894246
Page 237 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/24/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-24-2020 14:04:20 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894247
Page 238 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-01-2020 10:19:36 (UTC+02:00) Harare,
PretoriaNot considered COVID related as it was 1 day
post vaccine
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894248
Page 239 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894249
Page 240 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894250
Page 241 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894251
Page 242 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894252
Page 243 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894253
Page 244 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894254
Page 245 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894255
Page 246 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894256
Page 247 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894257
Page 248 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
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Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Dec-01-2020 13:17:24 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-01-2020 13:17:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894265
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894270
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Dec-01-2020 13:18:26 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
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(b) (4)
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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: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-01-2020 13:18:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-01-2020 13:19:01 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-01-2020 13:19:01 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894285
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-01-2020 13:19:01 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-23-2021 13:33:42 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-23-2021 13:33:42 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0894288
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-23-2021 13:34:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0894289
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-23-2021 13:34:09 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0894290
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***Confidential***
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Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
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Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 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-23-2021 13:32:14 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Jan-27-2021 15:01:24 (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-30-2020 10:40:54 (UTC+02:00) Harare,
PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene Nell Approved Nov-12-2020 21:07:54 (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.
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894291
Page 282 of 425
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-08-2020 11:35:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-08-2020 11:35:51
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894292
Page 283 of 425
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-08-2020 11:37:12
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/8/2020Initial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894293
Page 284 of 425
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-08-2020 11:35:40
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12471220Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-08-2020 11:35:37
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1976Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-08-2020 11:37:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-08-2020 11:37:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-08-2020 11:37:21
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894294
Page 285 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 12:51:25
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894295
Page 286 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-08-2020 12:51:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020 12:51:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020 12:51:55
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0894296
Page 287 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-12-2020 10:42:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Temporal lobe
Epilepsy
Start Date: UNK/UNK/200
1
Ongoing: YESTranscription Error
Oct-08-2020 12:52:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Epilepsy
Start Date: UNK/UNK/2
001
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-08-2020 12:52:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020 12:38:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-12-2020 10:42:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-12-2020 10:42:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Temporal lobe EpilepsyTranscription Error
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894297
Page 288 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-09-2020 22:46:26
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Please
specify type of
Epilepsy, if known.
Thanks
Oct-08-2020 12:52:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
EpilepsyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-08-2020 12:52:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-08-2020 12:52:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Dec-01-2020 09:20:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Bilateral tubal liga
tion Sterilized
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/201
8Transcription Error
Oct-12-2020 10:34:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Bilateral tubal lig
ation Sterilized
Start Date: UNK/UNK/2018Transcription Error
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0894298
Page 289 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: YES
Oct-09-2020 07:52:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Steralized
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4)
FDA-CBER-2021-5683-0894299
Page 290 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-09-2020 07:52:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-03-2020 20:19:53
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-03-2020 14:03:54
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Answered Test was not done at
V1 in error
Nov-02-2020 22:43:59
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Reissued:Opened GPD CLIN: Please
clarify what
information is to be
updated. Thank you.
Nov-02-2020 14:18:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Answered To update once
information is
available
Oct-30-2020 10:03:10
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Opened CLINQUERY: Since
bilateral tubal
ligation is not
sufficient to confirm
subject was not of
childbearing
potential, please
clarify if there is any
other information
that may be added to
the MH to confirm
childbearing status
(no preg test at visit
1).
Oct-29-2020 22:35:52
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 2: Candidate CLINQUERY: Since
bilateral tubal
ligation is not
sufficient to confirm
subject was not of
childbearing
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894300
Page 291 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
potential, please
clarify if there is any
other information
that may be added to
the MH to confirm
childbearing status
(no preg test at visit
1).
Oct-12-2020 20:37:16
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-12-2020 10:34:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-12-2020 10:34:23
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
Bilateral tubal ligation SterilizedTranscription Error
Oct-09-2020 18:05:31
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please update term
to provide further
detail (eg, bilateral
tubal ligation,
hysterectomy, etc).
Thank you.
Oct-09-2020 07:52:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
SteralizedInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-09-2020 07:52:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-01-2020 18:13:47
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894301
Page 292 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-01-2020 09:20:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Dec-01-2020 09:20:17
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Transcription Error
Nov-30-2020 19:25:15
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Reissued:Opened GPD CLIN:
Procedure should
not be marked as
ongoing, please
update if
appropriate. Thank
you.
Nov-26-2020 09:39:46
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Answered Procedure is not
ongoing, however
the result after the
procedure is
ongoing. Please
clarify whether the
procedure should be
marked as ongoing
or not.
Nov-26-2020 01:57:45
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Query 1: Opened GPD CLIN: Subject
is noted to have had
a surgical procedure
of 'bilateral tubal
ligation' which is
noted as ongoing
since 2018. Please
confirm if event
should be noted as
ongoing. If not,
please add stop date.
Oct-09-2020 07:52:27
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fc2\Final\Final On: 01-Apr-2021 03:51 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0894302
Page 293 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital
Subject No: 12471220 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-08-2020 12:53:03
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVETranscription Error
Oct-08-2020 12:52:44
(UTC+02:00) Harare,
PretoriaACV0PFEINFP6000 Data Entry:
The subject is known to be HIV P
OSITIVEInitial Entry
090177e196ae2fc2\Final\Fin
…[truncated]