125742 S1 M5 CRF c4591001 1229 12291083

Document text

Page 1 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828534
Page 2 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/1/2020
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828535
Page 3 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12291083]
2.Birth Date: UNK/UNK/1965
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
6.Racial Designation:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828536
Page 4 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828537
Page 5 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828538
Page 6 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828539
Page 7 of 768
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1997
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Human Immunoviral Infection]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2010
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menopause]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828540
Page 8 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is known to be HIV POSITIVE
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828541
Page 9 of 768
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Lancet Laboratories Netcare Garden City Mayfair]
3.Collection Date: Aug/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [2124]
Test: HIV RNA (Ultrasensitive)
Result: [<50]
LNMT Low
[28]
High
[58]
Unit
/mL
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828542
Page 10 of 768
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Lancet Laboratories]
3.Collection Date: Aug/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [4722]
Test: CD4_PX4722
Result: [0.500]
LNMT Low
[0.500]
High
[2.010]
Unit
10^3/mm3
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828543
Page 11 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
2.Weight: [122.6]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [51.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828544
Page 12 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828545
Page 13 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/1/2020
2.Randomization Number: [102631]
3.Randomization Group: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828546
Page 14 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BM9D7Z]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828547
Page 15 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BM9D7N]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828548
Page 16 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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/1/2020 14:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828549
Page 17 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828550
Page 18 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828551
Page 19 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828552
Page 20 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828553
Page 21 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828554
Page 22 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828555
Page 23 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BM9DMR]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828556
Page 24 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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/22/2020 11:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828557
Page 25 of 768
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828558
Page 26 of 768
***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, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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
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
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828559
Page 27 of 768
***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, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828560
Page 28 of 768
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
HIV RNA (Ultrasensitive)
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828561
Page 29 of 768
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
CD4_PX4722
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828562
Page 30 of 768
***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, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
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 [BM9J5D]
5.bSample ID [BRSF81]
5.cSample ID [BRSF82]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828563
Page 31 of 768
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828564
Page 32 of 768
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
HIV RNA (Ultrasensitive)
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828565
Page 33 of 768
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
CD4_PX4722
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828566
Page 34 of 768
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828567
Page 35 of 768
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828568
Page 36 of 768
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828569
Page 37 of 768
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
HIV RNA (Ultrasensitive)
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828570
Page 38 of 768
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
CD4_PX4722
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828571
Page 39 of 768
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828572
Page 40 of 768
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828573
Page 41 of 768
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
HIV RNA (Ultrasensitive)
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828574
Page 42 of 768
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
CD4_PX4722
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828575
Page 43 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828576
Page 44 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/17/2020
2.Date of First Symptom Started: Dec/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/23/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828577
Page 45 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.aSymptoms - Other Text: [New or Increased Nasal Congestion]
5.bSymptoms - Other Text: [Nasal Discharge]
5.cSymptoms - Other Text: [New or Increased Sputum Production]
5.dSymptoms - Other Text: [New or Increased Wheezing]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828578
Page 46 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/17/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828579
Page 47 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/17/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA - certified Mullah Medical Laboratory]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828580
Page 48 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Site collected the swab at site.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828581
Page 49 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BM9J9F]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828582
Page 50 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828583
Page 51 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
 1. DELETED HOSPITALIZATION STATUS
 HOSPITAL   Dec/28/2020  NO
Discharge Date
:
Jan/5/2021
 Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828584
Page 52 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/28/2020
4.Ongoing? NO
Discharge Date:
Jan/5/2021
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828585
Page 53 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828586
Page 54 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828587
Page 55 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO Comments
3.Toxicity Grade: 1 Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828588
Page 56 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828589
Page 57 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828590
Page 58 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828591
Page 59 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828592
Page 60 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828593
Page 61 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828594
Page 62 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828595
Page 63 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828596
Page 64 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828597
Page 65 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828598
Page 66 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828599
Page 67 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828600
Page 68 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828601
Page 69 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828602
Page 70 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/17/2020 Record Identifier: Systolic: Diastolic:
1  135  90 Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828603
Page 71 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 2.Not Applicable Record Identifier: Systolic: Diastolic:
1  Not Applicable  Not Applicable Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828604
Page 72 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [135]
Diastolic: [90]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [83]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828605
Page 73 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828606
Page 74 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/17/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828607
Page 75 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/17/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828608
Page 76 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828609
Page 77 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828610
Page 78 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828611
Page 79 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828612
Page 80 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828613
Page 81 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828614
Page 82 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828615
Page 83 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/2/2021
2.Date of First Symptom Started: Dec/31/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/5/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828616
Page 84 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.Symptoms - Other Text: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828617
Page 85 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/2/2021
 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828618
Page 86 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/2/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA - certified Chris Hani Baragwanath Laboratory]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828619
Page 87 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Test done at the hospital]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828620
Page 88 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Test done at the hospital]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828621
Page 89 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828622
Page 90 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/1/2021  NO
Discharge Date:
Jan/5/2021
 Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828623
Page 91 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/1/2021
4.Ongoing? NO
Discharge Date:
Jan/5/2021
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828624
Page 92 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828625
Page 93 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828626
Page 94 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Covid19 Pneumonia]
Date of Diagnosis:
Jan/2/2021
3.Toxicity Grade: 5
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828627
Page 95 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828628
Page 96 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828629
Page 97 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.Unknown  Unknown  Unknown  Unknown Sponsor-Defined Id
entifierTest:Result:
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828630
Page 98 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Unknown Comments
2.Laboratory Name and Address Unknown
[ ]Comments
3.Collection Date: Unknown
//Comments
4.Specimen Type: Unknown Comments
Lab Result
5.aSponsor ID: Unknown
[ ]Comments
Test: C Reactive Protein_PX329
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828631
Page 99 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Unknown
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Unknown
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828632
Page 100 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Unknown
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Unknown
[ ]Comments
Test: Bilirubin_PX21
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828633
Page 101 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Unknown
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Unknown
[ ]Comments
Test: Creatinine_PX48
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828634
Page 102 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Unknown  Unknown  Unknown  Unknown Sponsor-Defined I
dentifierTest:Result
:
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn 
Unknown  Unkno
wn Unkno
wn Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828635
Page 103 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Unknown Comments
2.Laboratory Name and Address Unknown
[ ]Comments
3.Collection Date: Unknown
//Comments
4.Specimen Type: Unknown Comments
Lab Result
5.aSponsor ID: Unknown
[ ]Comments
Test: Hemoglobin_PX1
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828636
Page 104 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Unknown
[ ]Comments
Test: Hematocrit_PX2
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Unknown
[ ]Comments
Test: Erythrocytes_PX3
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828637
Page 105 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Unknown
[ ]Comments
Test: Platelets_PX5
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Unknown
[ ]Comments
Test: Leukocytes_PX7
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828638
Page 106 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Unknown
[ ]Comments
Test: Neutrophils_PX608
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Unknown
[ ]Comments
Test: Eosinophils_PX609
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828639
Page 107 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.hSponsor ID: Unknown
[ ]Comments
Test: Monocytes_PX612
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Unknown
[ ]Comments
Test: Basophils_PX610
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828640
Page 108 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.jSponsor ID: Unknown
[ ]Comments
Test: Lymphocytes_PX611
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828641
Page 109 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Unknown Record Identifier: Systolic: Diastolic:
Unknown  Unknown  Unknown Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828642
Page 110 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: Unknown
1
Systolic: Unknown
[ ]Comments
Diastolic: Unknown
[ ]Comments
Respiratory Rate in
respirations/minute:Unknown
[ ]Comments
Heart Rate in beats/minute: Unknown
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828643
Page 111 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Unknown Record Identifier: Oxygen Saturation
Unknown  Unknown Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828644
Page 112 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: Unknown
1
SPO2 Pulse Oximetry % Unknown
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828645
Page 113 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Unknown  Unknown  Unknown  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828646
Page 114 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Unknown
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Unknown
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Unknown
[ ]Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828647
Page 115 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Unknown  Unknown  Unknown  Unknown  Unknow
n Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828648
Page 116 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Unknown
[ ]Comments
2.Category: Unknown Comments
3.Concomitant Medications
Pre-specified:Unknown 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).Unknown
[ ]Comments
5.Start Date: Unknown
//Comments
6.Ongoing? Unknown Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828649
Page 117 of 768
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Unknown  Unknown  Unknown  Unknown  Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828650
Page 118 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Jan/02/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Unknown
//Comments
2.Location of Assessment: Unknown Comments
3.Type of Imaging Exam: Unknown Comments
4.Assessment: Unknown Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828651
Page 119 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828652
Page 120 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828653
Page 121 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828654
Page 122 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828655
Page 123 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828656
Page 124 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828657
Page 125 of 768
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828658
Page 126 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828659
Page 127 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828660
Page 128 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828661
Page 129 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828662
Page 130 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828663
Page 131 of 768
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828664
Page 132 of 768
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828665
Page 133 of 768
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828666
Page 134 of 768
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828667
Page 135 of 768
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828668
Page 136 of 768
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/5/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828669
Page 137 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828670
Page 138 of 768
***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, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Done Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828671
Page 139 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Covid 19 Pneumo
nia Jan/1/2021 UNK:UN
K NO
End Date Time:
Jan/5/2021 03:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Diabetes Mellitus
 Dec/28/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828672
Page 140 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Covid 19 Pneumonia]
4.Start Date Time: Jan/1/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 03:00
6.Toxicity Grade: 4
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?
YES
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?
YES
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:
[Unknown]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828673
Page 141 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021007281]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828674
Page 142 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Diabetes Mellitus]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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?
YES
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:
[unknown]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828675
Page 143 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[2021007281] Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828676
Page 144 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828677
Page 145 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828678
Page 146 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828679
Page 147 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828680
Page 148 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828681
Page 149 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828682
Page 150 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828683
Page 151 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828684
Page 152 of 768
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828685
Page 153 of 768
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828686
Page 154 of 768
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828687
Page 155 of 768
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828688
Page 156 of 768
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828689
Page 157 of 768
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828690
Page 158 of 768
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Jan/5/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Covid 19 Pneumonia]
2.bCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Diabetes Mellitus type 2 ]
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828691
Page 159 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/5/2021
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828692
Page 160 of 768
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828693
Page 161 of 768
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Essack Mitha  Approved Mar-19-2021 12:54:16 (UTC+02:00) Harare,
PretoriaBOOK Signed
Affidavit:
By my dated signature below, I, EssackMitha, 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.
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828694
Page 162 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-02-2020 14:54:59 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828695
Page 163 of 768
***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: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-02-2020 14:55:59 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828696
Page 164 of 768
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Feb-25-2021 15:02:16 (UTC+02:00) Harare,
Pretoria
4Oct-30-2020 15:22:39 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0828697
Page 165 of 768
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-23-2020 12:52:33 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828698
Page 166 of 768
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6.aOct-23-2020 12:51:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828699
Page 167 of 768
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6.aOct-23-2020 12:51:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828700
Page 168 of 768
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6.aOct-23-2020 12:51:28 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828701
Page 169 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Feb-21-2021 16:58:53 (UTC+02:00) Harare,
Pretoria
4Nov-20-2020 11:43:12 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828702
Page 170 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828703
Page 171 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828704
Page 172 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828705
Page 173 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828706
Page 174 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828707
Page 175 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828708
Page 176 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828709
Page 177 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:00:05 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828710
Page 178 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormNov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828711
Page 179 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Nov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828712
Page 180 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Nov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828713
Page 181 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Nov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828714
Page 182 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Nov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828715
Page 183 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828716
Page 184 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828717
Page 185 of 768
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aNov-24-2020 11:02:50 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828718
Page 186 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:21:13 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828719
Page 187 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:21:13 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828720
Page 188 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:21:13 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828721
Page 189 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828722
Page 190 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828723
Page 191 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828724
Page 192 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828725
Page 193 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828726
Page 194 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828727
Page 195 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828728
Page 196 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:34 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828729
Page 197 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828730
Page 198 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828731
Page 199 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828732
Page 200 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828733
Page 201 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828734
Page 202 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828735
Page 203 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828736
Page 204 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:21:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828737
Page 205 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:22:09 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828738
Page 206 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:22:09 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828739
Page 207 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:22:09 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828740
Page 208 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:22:09 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828741
Page 209 of 768
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:22:09 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828742
Page 210 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:22:36 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828743
Page 211 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:22:36 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828744
Page 212 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:22:36 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828745
Page 213 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:22:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828746
Page 214 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:22:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828747
Page 215 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:22:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828748
Page 216 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:22:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828749
Page 217 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:22:52 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828750
Page 218 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828751
Page 219 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828752
Page 220 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828753
Page 221 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828754
Page 222 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828755
Page 223 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828756
Page 224 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828757
Page 225 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:10 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828758
Page 226 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828759
Page 227 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828760
Page 228 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828761
Page 229 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828762
Page 230 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828763
Page 231 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828764
Page 232 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828765
Page 233 of 768
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:23:28 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828766
Page 234 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:25:59 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828767
Page 235 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:25:59 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828768
Page 236 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:25:59 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828769
Page 237 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:26:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828770
Page 238 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:26:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828771
Page 239 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:26:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828772
Page 240 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:26:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828773
Page 241 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:26:19 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828774
Page 242 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828775
Page 243 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828776
Page 244 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828777
Page 245 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828778
Page 246 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828779
Page 247 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828780
Page 248 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828781
Page 249 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:26:42 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828782
Page 250 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormJan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828783
Page 251 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Jan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828784
Page 252 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Jan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828785
Page 253 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Jan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828786
Page 254 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Jan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828787
Page 255 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828788
Page 256 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828789
Page 257 of 768
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aJan-12-2021 16:27:06 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828790
Page 258 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aDec-18-2020 14:42:38 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828791
Page 259 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828792
Page 260 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828793
Page 261 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828794
Page 262 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
3Dec-18-2020 14:46:40 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828795
Page 263 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828796
Page 264 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
5Dec-18-2020 14:46:59 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828797
Page 265 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Dec-18-2020 14:47:37 (UTC+02:00) Harare,
PretoriaNot Done
6Dec-18-2020 14:47:17 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828798
Page 266 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-21-2020 13:16:11 (UTC+02:00) Harare,
Pretoria
FormDec-18-2020 14:49:38 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828799
Page 267 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-21-2020 13:16:11 (UTC+02:00) Harare,
Pretoria
1Dec-18-2020 14:49:38 (UTC+02:00) Harare,
PretoriaNot Applicable
1Dec-18-2020 14:48:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828800
Page 268 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-21-2020 13:16:11 (UTC+02:00) Harare,
Pretoria
2Dec-18-2020 14:49:38 (UTC+02:00) Harare,
PretoriaNot Applicable
2Dec-18-2020 14:49:01 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828801
Page 269 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-21-2020 13:16:11 (UTC+02:00) Harare,
Pretoria
3Dec-18-2020 14:49:38 (UTC+02:00) Harare,
PretoriaNot Applicable
3Dec-18-2020 14:49:22 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828802
Page 270 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-18-2020 14:50:36 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828803
Page 271 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-18-2020 14:50:55 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828804
Page 272 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-18-2020 14:51:19 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828805
Page 273 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-18-2020 14:51:44 (UTC+02:00) Harare,
PretoriaNot Applicable
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828806
Page 274 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828807
Page 275 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828808
Page 276 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828809
Page 277 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828810
Page 278 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828811
Page 279 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828812
Page 280 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828813
Page 281 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828814
Page 282 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828815
Page 283 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828816
Page 284 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828817
Page 285 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828818
Page 286 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828819
Page 287 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828820
Page 288 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828821
Page 289 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828822
Page 290 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828823
Page 291 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828824
Page 292 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828825
Page 293 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828826
Page 294 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828827
Page 295 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828828
Page 296 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828829
Page 297 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828830
Page 298 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828831
Page 299 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828832
Page 300 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828833
Page 301 of 768
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1229 Site Name: (1229) Newton Clinical Resarch
Subject No: 12291083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fDec-18-2020 14:52:55 (UTC+02:00) Harare,
PretoriaNot Done
090177e196ae306b\Final\Final On: 01-Apr-2021 04:06 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-
…[truncated]