125742 S1 M5 CRF c4591001 1247 12471137

Document text

Page 1 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893559
Page 2 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/30/2020
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893560
Page 3 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12471137]
2.Birth Date: UNK/UNK/1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
WHITE
6.Racial Designation:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893561
Page 4 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893562
Page 5 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893563
Page 6 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893564
Page 7 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post menopausal]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic obstructive pulmonary disease]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Slip disc LS with chronic pain]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893565
Page 8 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic back pain]
Start Date: UNK/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jun/UNK/2019
Ongoing: YES
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893566
Page 9 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893567
Page 10 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
2.Weight: [92.0]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893568
Page 11 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS Comments
2.Lab Sub-Panel: PREGNANCY Comments
3.Collection Date: Sep/30/2020 Comments
4.Laboratory Name and
Address (Derived)[STUDY SITE] Comments
5.Specimen Type: URINE Comments
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893569
Page 12 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/30/2020
2.Randomization Number: [102142]
3.Randomization Group: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893570
Page 13 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CMP]
5.bSample ID [BRSF31]
5.cSample ID [BRSF32]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893571
Page 14 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9CN0]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893572
Page 15 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/30/2020 14:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893573
Page 16 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893574
Page 17 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893575
Page 18 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893576
Page 19 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893577
Page 20 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893578
Page 21 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [35.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893579
Page 22 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/21/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893580
Page 23 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM9D24]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893581
Page 24 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/21/2020 11:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893582
Page 25 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893583
Page 26 of 257
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893584
Page 27 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893585
Page 28 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893586
Page 29 of 257
***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: 12471137 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/18/2020
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 [BM9FSG]
5.bSample ID [BRY9H7]
5.cSample ID [BRY9H8]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893587
Page 30 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893588
Page 31 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893589
Page 32 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893590
Page 33 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893591
Page 34 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893592
Page 35 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893593
Page 36 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893594
Page 37 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893595
Page 38 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893596
Page 39 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893597
Page 40 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893598
Page 41 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893599
Page 42 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893600
Page 43 of 257
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893601
Page 44 of 257
***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: 12471137 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:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893602
Page 45 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893603
Page 46 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893604
Page 47 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893605
Page 48 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 1.ADVERS
E EVEN
T 1 Worsening back pain  Nov/9/202
0 UNK:UN
K NO
End Date Time:
Nov/15/2020 U
NK:UNK
 Repeating
Pages
 2.ADVERS
E EVEN
T 2 Worsening pain related to
L5/S1 and L4/L5 disc prot
rusion Nov/9/202
0 UNK:UN
K YES  Repeating
Pages
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893606
Page 49 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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)[Worsening back pain]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/15/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893607
Page 50 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Back pain (Etiology unknown)]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893608
Page 51 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893609
Page 52 of 257
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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)[Worsening pain related to L5/S1 and L4/L5 disc protrusion]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893610
Page 53 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Back pain]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893611
Page 54 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020458322]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893612
Page 55 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedicatio
n ErrorStart Da
teIs the medication err
or Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.Not Appl
icable Not Applic
able Not Appl
icable Not Applicable  Not Applicable  Repeating
Pages
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893613
Page 56 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893614
Page 57 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart D
ateForm Instan
ce
 1.Not Applicable
 Not Applicabl
e Not Applicable  Not Applic
able Not App
licable Repeating
Pages
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893615
Page 58 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893616
Page 59 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.Not Applicable
 Not Applicabl
e Not Applicable  Not Applic
able Not Appl
icable Repeating
Pages
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893617
Page 60 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893618
Page 61 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893619
Page 62 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Id
entifierCon Non-Drug Treatmen
ts Pre-specifiedTreatmen
tStart Dat
eForm Instanc
e
 1.Not Appli
cable Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893620
Page 63 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893621
Page 64 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893622
Page 65 of 257
***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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893623
Page 66 of 257
***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: 12471137 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/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893624
Page 67 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893625
Page 68 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12471137 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:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893626
Page 69 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12471137 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:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893627
Page 70 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12471137 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?
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893628
Page 71 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893629
Page 72 of 257
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893630
Page 73 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893631
Page 74 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893632
Page 75 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893633
Page 76 of 257
***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: 12471137 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 [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893634
Page 77 of 257
***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: 12471137 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: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893635
Page 78 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893636
Page 79 of 257
***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: 12471137 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 NOT willing to return for Vaccination 3 OR
otherwise not eligible
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893637
Page 80 of 257
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893638
Page 81 of 257
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893639
Page 82 of 257
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893640
Page 83 of 257
***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: 12471137 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/18/2020
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893641
Page 84 of 257
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893642
Page 85 of 257
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12471137 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
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893643
Page 86 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-01-2020 07:04:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893644
Page 87 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-01-2020 07:11:07 (UTC+02:00)
Harare, Pretoria
FormOct-01-2020 07:05:01 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893645
Page 88 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
FormOct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893646
Page 89 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
1Oct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893647
Page 90 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
2Oct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893648
Page 91 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
3Oct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893649
Page 92 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
4Oct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893650
Page 93 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
5Oct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893651
Page 94 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
6.aOct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893652
Page 95 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
6.aOct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893653
Page 96 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-22-2020 09:19:27 (UTC+02:00)
Harare, Pretoria
6.aOct-01-2020 07:06:48 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893654
Page 97 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893655
Page 98 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893656
Page 99 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893657
Page 100 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893658
Page 101 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893659
Page 102 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893660
Page 103 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893661
Page 104 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893662
Page 105 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893663
Page 106 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893664
Page 107 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-19-2020 07:03:07 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893665
Page 108 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893666
Page 109 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893667
Page 110 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893668
Page 111 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893669
Page 112 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893670
Page 113 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-19-2020 07:03:24 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893671
Page 114 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893672
Page 115 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893673
Page 116 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893674
Page 117 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893675
Page 118 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893676
Page 119 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893677
Page 120 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893678
Page 121 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893679
Page 122 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893680
Page 123 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893681
Page 124 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
- Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-19-2020 07:03:41 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893682
Page 125 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893683
Page 126 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893684
Page 127 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893685
Page 128 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893686
Page 129 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893687
Page 130 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893688
Page 131 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-19-2020 07:04:13 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893689
Page 132 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-19-2020 07:03:57 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893690
Page 133 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-19-2020 07:03:57 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893691
Page 134 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-19-2020 07:03:57 (UTC+02:00)
Harare, PretoriaNot Applicable
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893692
Page 135 of 257
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-22-2021 11:33:56 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene
Nell Approved Jan-27-2021 15:52:12 (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-19-2020 07:01:29 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893693
Page 136 of 257
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
N/A
Haylene
Nell Approved Nov-18-2020 18:28:08 (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-18-2020 15:06:57 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene
Nell Approved Nov-18-2020 14:59:08 (UTC+02:00)
Harare, PretoriaBOOK Signed
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893694
Page 137 of 257
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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-18-2020 10:19:11 (UTC+02:00)
Harare, PretoriaEdit - All
signatures
invalidated
Affidavit:
N/A
Haylene
Nell Approved Nov-12-2020 15:35:37 (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.
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893695
Page 138 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-30-2020
14:00:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-30-2020
14:00:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893696
Page 139 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-30-2020
14:00:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/30/2020Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893697
Page 140 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-30-2020
14:00:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12471137Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-30-2020
14:00:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1968Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-30-2020
14:01:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-30-2020
14:01:34
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SPAInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893698
Page 141 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare, Pretoria NISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-30-2020
14:01:34
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BLACK OR AFRICA
N AMERICAN
WHITEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893699
Page 142 of 257
***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: 12471137 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-01-2020
07:04:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893700
Page 143 of 257
***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: 12471137 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-01-2020
07:04:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-01-2020
07:04:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-01-2020
07:04:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893701
Page 144 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-23-2020
14:24:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:post men
opausal
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-23-2020
14:24:58
(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
Nov-23-2020
19:10:44
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Nov-23-2020 ACV0PFEINFP6000  Giselle Query 1: Reissue Response satisfy
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893702
Page 145 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
17:04:56
(UTC+02:00)
Harare, PretoriaCastillo d:Opened query. Thank you.
Nov-23-2020
12:28:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answer
edUpdate
Nov-23-2020
00:30:10
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissue
d:OpenedAppreciate your
response.
Hypercholesterolemia
is a relevant
condition for certain
cases of back pain.
Per CRF CG (sect
8.7.2.)"If clinically
significant, record
detailed past and/or
concomitant medical
conditions." Kindly
reassess and update
form. Thanks
Nov-21-2020
15:00:08
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answer
edOnly clinically
significant medical
history to be updated
on medical history
page. Should
hypercholesterolemia
be added as
investigator marked
condition NCS?
Nov-21-2020
03:03:19ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Per narrative, the
subject has a Med Hx
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893703
Page 146 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoriaof
hypercholesterolemia
from 2019, chronic
obstructive
pulmonary disease
(COPD) from 2010
and chronic back pain
from 2019. Please
revise and update this
form for additional
Med Hx. Thank you.
Oct-23-2020
14:24:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
post menopausalInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-23-2020
14:24:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-23-2020
14:24:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893704
Page 147 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b
Date Location User Value Reason
Nov-21-2020
14:57:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:Chronic obstr
uctive pulmo
nary disease
Start Da
te:UNK/UNK/2
010
Ongoing
:YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893705
Page 148 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Nov-21-2020
14:57:19
(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-21-2020
14:57:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Chronic obstructive pu
lmonary diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-21-2020
14:57:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-21-2020
14:57:19
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893706
Page 149 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c
Date Location User Value Reason
Nov-21-2020
14:57:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Slip disc LS
with chronic
pain
Start Dat
e:UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893707
Page 150 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Nov-21-2020
14:57:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-21-2020
14:57:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Slip disc LS with chro
nic painInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-21-2020
14:57:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-21-2020
14:57:52
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893708
Page 151 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d
Date Location User Value Reason
Nov-21-2020
14:58:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Chronic b
ack pain
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893709
Page 152 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Nov-21-2020
14:58:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-21-2020
14:58:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Chronic back painInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-21-2020
14:58:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-21-2020
14:58:20
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893710
Page 153 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e
Date Location User Value Reason
Nov-23-2020
12:28:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical Hi
story Term
:Hyperchol
esterolemi
a
Start Date: Jun/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893711
Page 154 of 257
***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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Nov-23-2020
12:28:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020
12:28:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-23-2020
12:28:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Jun/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-23-2020
12:28:17
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893712
Page 155 of 257
***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: 12471137 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-01-2020
07:05:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893713
Page 156 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
92.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-01-2020
07:06:39ACV0PFEINFP6000  Data Entry:
175.0Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893714
Page 157 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
5. Unit:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
7.a
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:36.5
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893715
Page 158 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Record Identifier:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-01-2020
07:06:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893716
Page 159 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893717
Page 160 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
Oct-22-2020
09:19:27
(UTC+02:00)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (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-2021-5683-0893718
Page 161 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare, Pretoria
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893719
Page 162 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Test:: Not Ap
plicabl
e
Result::
Not Done:: NOT D
ONE
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:
Test:: Not Ap
plicabl
e
Result::
Not Done::Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
6.a Sponsor ID:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893720
Page 163 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-22-2020
09:20:03
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-23-2020
17:27:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-23-2020 ACV0PFEINFP6000  Query 1: Answered updated
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (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-2021-5683-0893721
Page 164 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14:25:32
(UTC+02:00)
Harare, Pretoria
Oct-22-2020
21:20:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Reissued:
OpenedCLINQUERY:
medical history
form has been
unfrozen
Oct-22-2020
09:20:38
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Please unfreeze
Medhx page.
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-21-2020
21:05:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Reissued:
OpenedCLINQUERY:
medical history
form has been
unfrozen
Oct-21-2020
14:36:58
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Please unfreeze
MedHx to
update.
Oct-20-2020
19:00:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Subject is less
than 60 years
old and it is not
clear from her
medhx why a
pregnancy test
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0893722
Page 165 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
was not
performed.
Please review
and update the
MedHx log as
appropriate else
clarify. Thank
you.
Oct-20-2020
16:57:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Subject is less
than 60 years
old and it is not
clear from her
medhx why a
pregnancy test
was not
performed.
Please review
and update the
MedHx log as
appropriate else
clarify. Thank
you.
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-22-2020
09:20:03ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893723
Page 166 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
Oct-22-2020
09:19:27
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: Initial Entry
Oct-01-2020
07:06:48
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893724
Page 167 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-01-2020
07:07:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-01-2020
07:07:09
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
102142Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893725
Page 168 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
07:09:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
07:09:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
10:55:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
07:09:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893726
Page 169 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
correct as
appropriate.
Oct-01-2020
07:09:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
10:55:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9CM
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
10:55:13
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9CMPInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
10:55:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSF31Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893727
Page 170 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Sample ID
Date Location User Value Reason
Oct-01-2020
10:55:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSF31Initial Entry
5.c
Date Location User Value Reason
Oct-01-2020
10:56:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRSF32Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020
10:56:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRSF32Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893728
Page 171 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
07:10:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
07:10:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
10:54:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
07:10:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893729
Page 172 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
correct as
appropriate.
Oct-01-2020
07:10:02
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
10:54:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9CN
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
10:54:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9CN0Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893730
Page 173 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Sep/30/2020 14:35Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893731
Page 174 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893732
Page 175 of 257
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-01-2020
07:10:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893733
Page 176 of 257
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-01-2020
07:10:33
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893734
Page 177 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 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-22-2020
09:21:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893735
Page 178 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893736
Page 179 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893737
Page 180 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.b Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893738
Page 181 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893739
Page 182 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.d Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893740
Page 183 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893741
Page 184 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.f Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893742
Page 185 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR WInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893743
Page 186 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare, Pretoria ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893744
Page 187 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was complet
ed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893745
Page 188 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893746
Page 189 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893747
Page 190 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020
09:21:42
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893748
Page 191 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2.a
Date Location User Value Reason
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:35.8
Temperatur
e Unit:C
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893749
Page 192 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Temperature:
Date Location User Value Reason
Oct-23-2020
15:51:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-22-2020
09:24:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Original value
is correct
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature
35.8 C is
outside of
Normal Range
36.1 - 37.5 C.
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
35.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893750
Page 193 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-22-2020
09:22:21
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893751
Page 194 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-22-2020
09:22:39ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893752
Page 195 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
5. Specimen Type:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893753
Page 196 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
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: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Test:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-22-2020
09:22:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893754
Page 197 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
09:22:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
09:22:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
09:24:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
09:22:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0893755
Page 198 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
correct as
appropriate.
Oct-22-2020
09:22:59
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
09:24:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9D2
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
09:24:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9D24Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893756
Page 199 of 257
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 11:39Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893757
Page 200 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Harare, Pretoria
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893758
Page 201 of 257
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-22-2020
09:23:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893759
Page 202 of 257
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020
10:19:11
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893760
Page 203 of 257
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893761
Page 204 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893762
Page 205 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.b Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893763
Page 206 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.c Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms p
resent on the last
day the Subject D
iary was complete
d?:N
OInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893764
Page 207 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.d Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893765
Page 208 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.e Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893766
Page 209 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.f Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893767
Page 210 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.g Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893768
Page 211 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NO
2.h Symptom:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-18-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893769
Page 212 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10:19:40
(UTC+02:00)
Harare, Pretoria(autocalc) DELTOID MUSCLE
4. Injection Site Body Side:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection sit
e reactions prese
nt on the last day
the Subject Diary
was completed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020
10:19:40ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893770
Page 213 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoria
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site Re
action::SW
EL
LIN
G
Were injection si
te reactions pres
ent on the last da
y the Subject Di
ary was complet
ed?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893771
Page 214 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJEC
TION
SITE
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893772
Page 215 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-18-2020
10:19:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893773
Page 216 of 257
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020
10:19:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020
10:19:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020
15:06:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-18-2020
12:05:30
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893774
Page 217 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
correct as
appropriate.
Nov-18-2020
10:19:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Nov-18-2020
10:19:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020
15:06:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID
:BM9FS
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-18-2020
15:06:57
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BM9FSGInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893775
Page 218 of 257
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Nov-18-2020
15:07:16
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRY9H7Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-18-2020
15:07:16
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRY9H7Initial Entry
5.c
Date Location User Value Reason
Nov-18-2020
15:07:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Sample ID: BRY9H8Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020
15:07:26
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
BRY9H8Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893776
Page 219 of 257
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893777
Page 220 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000 Form Created
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893778
Page 221 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-23-2020
18:27:12
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-21-2020
14:58:55
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Medical
history updated
Nov-20-2020
23:03:38ACV0PFEINFP6000  Query 1: Reissued:O
penedGPD CLIN:
The medical
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893779
Page 222 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC+02:00)
Harare, Pretoriahistory CRF
has been
unlocked,
please update
as appropriate.
Thank you.
Nov-20-2020
12:08:46
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered Please unlock
medical history
page in order
to update data
Nov-19-2020
18:13:49
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened GPD CLIN:
Does subject
have a history
of back pain?
If yes, please
update medical
history CRF.
Thank you.
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Worsening back painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893780
Page 223 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-23-2020
18:26:23
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-23-2020
12:35:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New
Information
Nov-23-2020
12:35:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/15/2020 U
NK:UNKNew
Information
Nov-20-2020
21:40:05
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Reissued:
OpenedGPD CLIN:
Please add a
stop date for the
event of Grade
2 worsening
back pain.
Thank you.
Nov-20-2020
12:10:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answered 15 Nov 2020
SAE updated to
Grade 3 as pain
was severe
enough to
justify
hospitalization
Nov-19-2020 ACV0PFEINFP6000  Query 1: Opened GPD CLIN:
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (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-2021-5683-0893781
Page 224 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
18:17:28
(UTC+02:00)
Harare, PretoriaTwo AEs of
Grade 2
worsening back
pain are
reported with
overlapping
dates. Please
confirm in NON
SAE of Grade 2
worsening back
pain that started
on 9 NOV 2020
is still ongoing.
If not, please
update and add
a stop date.
Thank you.
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0893782
Page 225 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Nov-23-2020
13:22:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-20-2020
12:04:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Worsening
back pain:
Response to
"Is the adverse
event serious?"
is 'No' but
"Serious
Adverse Event
Number" is
present.
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-19-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0893783
Page 226 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
07:01:29
(UTC+02:00)
Harare, PretoriaNO
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-27-2021
23:09:43
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response
satisfies query
Jan-27-2021
11:16:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-27-2021
11:16:50
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
Back pain (Eti
ology unknow
n)Changed
Information
Jan-25-2021
15:18:01
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please review
field for 'If
Other, specify' -
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893784
Page 227 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
field should
capture possible
etiology of
event
Jan-22-2021
19:14:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY:
Please review
field for 'If
Other, specify' -
field should
capture possible
etiology of
event
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
Back painInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893785
Page 228 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-23-2020
12:40:55
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-23-2020
12:40:55
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDNew
Information
Nov-23-2020
12:35:39
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Worsening back
pain: Response
to "What was
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893786
Page 229 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOT RECOVERED
/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020
07:01:29
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-23-2020
13:22:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry: downgraded to
non serious
Nov-20-2020
12:04:47
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
2020458322Initial Entry
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893787
Page 230 of 257
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021
23:47:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 3: Closed Thanks.
Jan-15-2021
23:20:33
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 3: Answe
redSub-I followed up
with patient. Outcome
was changed to
Recovering.
Unknown if patient
went for PCP visit
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893788
Page 231 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-06-2021
00:54:33
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 3: Opene
dPer safety report, the
participant was in
severe pain and yet
not recovered. The
subject had a pending
PCP visit. Kindly
provide further
updates if any. Thank
you.
Dec-01-2020
11:47:23
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-30-2020
06:44:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Worsening pain
related to L5/S1
and L4/L5 disc
protrusionTranscription Error
Nov-27-2020
12:41:25
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Worsening back
pain related toL
5/S1 and L4/L5
disc protrusionChanged Information
Nov-27-2020
12:39:54
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 2: Answe
redNo fup form needed.
AE term updated
Nov-26-2020
14:12:35
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 2: Opene
dSAE RECON:
AER#2020458322,the
term was updated to
'Worsening pain
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (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-2021-5683-0893789
Page 232 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
related to L5/S1 and
L4/L5 disc
protrusionin Safety
database while
recorded as
'Worsening back pain'
in AE CRF. Please
confirm.If safety
update is required,
please submit a ffup
form.
Nov-23-2020
22:11:36
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Nov-23-2020
12:39:00
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Answe
redStill awaiting hospital
notes - will update as
soon as we receive
the notes
Nov-21-2020
03:10:45
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Giselle
CastilloQuery 1: Opene
dPer narrative the
subject was
hospitalized for
longer than 24hrs,
kindly clarify if there
was an specific
diagnosis made
during hospital stay.
Please submit a FU
report (including
tests/imaging
performed) if
discharge summary is
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0893790
Page 233 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
available. Thank you.
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Worsening back
painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-02-2020
09:56:28
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-02-2020
07:55:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription Error
Dec-02-2020
07:55:31
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:
UNKTranscription Error
Dec-01-2020
11:50:24
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020458322,
onset date was
recorded as
09Nov2020 in
Safety database
however, recorded
as 15Nov2020 on
AE CRF. Please
confirm correct
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893791
Page 234 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer
Hospital
Subject No: 12471137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
Nov/15/2020 UNK
:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-20-2020
12:09:56
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
3Changed
Information
Nov-19-2020
07:02:40
(UTC+02:00)
Harare, PretoriaACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae2fbf\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0893792
Page 235 of 257
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
…[truncated]