125742 S1 M5 CRF c4591001 1091 10911197

Document text

Page 1 of 625
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788990
Page 2 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788991
Page 3 of 625
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10911197]
2.Birth Date: /1966
3.Sex: MALE
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:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788992
Page 4 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788993
Page 5 of 625
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788994
Page 6 of 625
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788995
Page 7 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[restless leg syndrome]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: Oct/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/1976
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chest pain]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788996
Page 8 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cyst in esophagus]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[removal of esophageal cyst]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DVT]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788997
Page 9 of 625
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [84.6]
3.Unit: kg
4.Height: [181.0]
5.Unit: cm
6.Body Mass Index: [25.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788998
Page 10 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [71958]
3.Randomization Group: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788999
Page 11 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8M9S]
5.bSample ID [BP8M9T]
5.cSample ID [BP8M9V]
5.dSample ID [BPR4K8]
5.eSample ID [BPR4K9]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789000
Page 12 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8M9R]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789001
Page 13 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: Aug/28/2020 11:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789002
Page 14 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789003
Page 15 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789004
Page 16 of 625
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789005
Page 17 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPYSVL]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789006
Page 18 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/17/2020 10:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789007
Page 19 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789008
Page 20 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BRFGXF]
5.bSample ID [BSGXSZ]
5.cSample ID [BSGXSY]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789009
Page 21 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789010
Page 22 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/8/2020
2.Date of First Symptom Started: Sep/3/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES Comments
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [ ] Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789011
Page 23 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789012
Page 24 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789013
Page 25 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Sep/8/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV14147]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789014
Page 26 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab completed] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789015
Page 27 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789016
Page 28 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789017
Page 29 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789018
Page 30 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789019
Page 31 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789020
Page 32 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789021
Page 33 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Ide
ntifierTest: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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789022
Page 34 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789023
Page 35 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789024
Page 36 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789025
Page 37 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789026
Page 38 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for La
b 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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789027
Page 39 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789028
Page 40 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789029
Page 41 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789030
Page 42 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789031
Page 43 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789032
Page 44 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789033
Page 45 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789034
Page 46 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
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
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789035
Page 47 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789036
Page 48 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789037
Page 49 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789038
Page 50 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789039
Page 51 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789040
Page 52 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789041
Page 53 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789042
Page 54 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789043
Page 55 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789044
Page 56 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/19/2020
2.Date of First Symptom Started: Sep/26/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/30/2020
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? YES
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? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789045
Page 57 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789046
Page 58 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789047
Page 59 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [CV43569]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789048
Page 60 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:[subject completed self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789049
Page 61 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?NO
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789050
Page 62 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Id
entifierCon Non-Drug Treatments
Pre-specifiedTreatment TreatmentStart Da
teForm Instanc
e
 1.1  YES  HIGH FLOW OXYGEN
THERAPY HIGH FLOW OXYGEN
THERAPY Sep/27/2
020 Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789051
Page 63 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Sep/27/2020
6.Ongoing? NO
End Date:
Sep/28/2020
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789052
Page 64 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789053
Page 65 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789054
Page 66 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789055
Page 67 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789056
Page 68 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789057
Page 69 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789058
Page 70 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789059
Page 71 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789060
Page 72 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789061
Page 73 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789062
Page 74 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789063
Page 75 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789064
Page 76 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789065
Page 77 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789066
Page 78 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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.Start Date: //
6.Ongoing?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789067
Page 79 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789068
Page 80 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/19/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789069
Page 81 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789070
Page 82 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/29/2020
2.Date of First Symptom Started: Oct/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/12/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789071
Page 83 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789072
Page 84 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789073
Page 85 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Nov/3/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV43651]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789074
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:[subject to complete self-swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789075
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789076
Page 88 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789077
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789078
Page 90 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789079
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789080
Page 92 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789081
Page 93 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789082
Page 94 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789083
Page 95 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789084
Page 96 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789085
Page 97 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789086
Page 98 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789087
Page 99 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789088
Page 100 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789089
Page 101 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789090
Page 102 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789091
Page 103 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789092
Page 104 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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.Start Date: //
6.Ongoing?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789093
Page 105 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789094
Page 106 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Oct/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789095
Page 107 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789096
Page 108 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/18/2020
2.Date of First Symptom Started: Nov/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/2/2020
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? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789097
Page 109 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789098
Page 110 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789099
Page 111 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/23/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab kit sent to subject- pending receipt]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV60073]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789100
Page 112 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:[subject advised to self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789101
Page 113 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789102
Page 114 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789103
Page 115 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789104
Page 116 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789105
Page 117 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789106
Page 118 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789107
Page 119 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789108
Page 120 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789109
Page 121 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789110
Page 122 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789111
Page 123 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789112
Page 124 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789113
Page 125 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789114
Page 126 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789115
Page 127 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789116
Page 128 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789117
Page 129 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789118
Page 130 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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.Start Date: //
6.Ongoing?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789119
Page 131 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789120
Page 132 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Nov/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789121
Page 133 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/06/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789122
Page 134 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/06/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BP8LY3]
5.bSample ID [BNWW4Z]
5.cSample ID [BNWW50]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789123
Page 135 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Nov/16/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789124
Page 136 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Nov/16/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
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 [BRFH51]
5.bSample ID [BSGXWW]
5.cSample ID [BSGXWX]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789125
Page 137 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled Visit
on Dec/01/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789126
Page 138 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 3 - Unscheduled Visit
on Dec/01/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BRFH65]
5.bSample ID [BSGXYM]
5.cSample ID [BSGXYN]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789127
Page 139 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 4 - Unscheduled Visit
on Dec/16/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D1
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789128
Page 140 of 625
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 4 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
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 [BS3FLS]
5.bSample ID [BGH6XX]
5.cSample ID [BS3FLW]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789129
Page 141 of 625
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/08/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789130
Page 142 of 625
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/08/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789131
Page 143 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789132
Page 144 of 625
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789133
Page 145 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789134
Page 146 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789135
Page 147 of 625
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1. DELETED ADVERSE EV
ENT 1  Pneumonia  Sep/26/2020 UNK
:UNK YES  Repeating
Pages
 2. ADVERSE EV
ENT 2  Diarrhea  Sep/17/2020 UNK
:UNK NO
End Date Time:
Oct/3/2020 UNK:UNK
 Repeating
Pages
 3. ADVERSE EV
ENT 3  nasal congestion  Oct/10/2020 UNK
:UNK NO
End Date Time:
Oct/17/2020 10:00
 Repeating
Pages
 4. ADVERSE EV
ENT 4  poisoning by coc
aine Sep/26/2020 UNK
:UNK NO
End Date Time:
Sep/27/2020 UNK:UNK
 Repeating
Pages
 5. ADVERSE EV
ENT 5  hypoxia  Sep/26/2020 UNK
:UNK NO
End Date Time:
Sep/27/2020 UNK:UNK
 Repeating
Pages
 6. ADVERSE EV
ENT 6  Aspiration Pneu
monia Sep/26/2020 UNK
:UNK NO
End Date Time:
Oct/6/2020 UNK:UNK
 Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789136
Page 148 of 625
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Pneumonia ]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[community acquired infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789137
Page 149 of 625
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020382050 ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789138
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Diarrhea]
4.Start Date Time: Sep/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789139
Page 151 of 625
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789140
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***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[nasal congestion]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 10:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[environmental irritant]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789141
Page 153 of 625
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789142
Page 154 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[poisoning by cocaine]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/27/2020 UNK:UNK
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:
[substance abuse]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789143
Page 155 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020382050]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789144
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***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[hypoxia]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/27/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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:
[opioid overdose]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789145
Page 157 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020382050]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789146
Page 158 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Aspiration Pneumonia]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/6/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[poisoning by cocaine]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789147
Page 159 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020382050]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789148
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789150
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789151
Page 163 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789153
Page 165 of 625
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789154
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789155
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789156
Page 168 of 625
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789157
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789158
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***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789159
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789160
Page 172 of 625
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789161
Page 173 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789162
Page 174 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789163
Page 175 of 625
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789164
Page 176 of 625
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789165
Page 177 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/24/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789166
Page 178 of 625
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789167
Page 179 of 625
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789168
Page 180 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789169
Page 181 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/1/2021
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789170
Page 182 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789171
Page 183 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789172
Page 184 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1S4Z]
5.bSample ID [BSGY91]
5.cSample ID [BSGY90]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789173
Page 185 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1S4Y]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789174
Page 186 of 625
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/1/2021 08:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789175
Page 187 of 625
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789176
Page 188 of 625
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789177
Page 189 of 625
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789178
Page 190 of 625
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789179
Page 191 of 625
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789180
Page 192 of 625
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789181
Page 193 of 625
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789182
Page 194 of 625
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789183
Page 195 of 625
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789184
Page 196 of 625
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789185
Page 197 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789186
Page 198 of 625
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789187
Page 199 of 625
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0789188
Page 200 of 625
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-29-2020 11:37:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789189
Page 201 of 625
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-03-2020 16:08:00 (UTC-05:00) Eastern Time
(US & Canada)
FormAug-29-2020 11:39:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789190
Page 202 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4.cSep-11-2020 09:15:16 (UTC-05:00) Eastern Time
(US & Canada)intermittent, ongoing
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789191
Page 203 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 09:04:39 (UTC-05:00) Eastern Time
(US & Canada)intermittent, ongoing
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789192
Page 204 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789193
Page 205 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789194
Page 206 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789195
Page 207 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789196
Page 208 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789197
Page 209 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789198
Page 210 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789199
Page 211 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789200
Page 212 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789201
Page 213 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Sep-11-2020 11:14:01 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789202
Page 214 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-13-2020 12:53:47 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-11-2020 11:14:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789203
Page 215 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-13-2020 12:53:47 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-11-2020 11:14:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789204
Page 216 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-13-2020 12:53:47 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-11-2020 11:14:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789205
Page 217 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-13-2020 12:53:47 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-11-2020 11:14:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789206
Page 218 of 625
***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: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-13-2020 12:53:47 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-11-2020 11:14:12 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789207
Page 219 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-02-2020 10:47:44 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-11-2020 11:14:34 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789208
Page 220 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Oct-02-2020 10:47:44 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-11-2020 11:14:34 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789209
Page 221 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Oct-02-2020 10:47:44 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-11-2020 11:14:34 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789210
Page 222 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Oct-02-2020 10:47:44 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-11-2020 11:14:34 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789211
Page 223 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Oct-02-2020 10:47:44 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-11-2020 11:14:34 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789212
Page 224 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789213
Page 225 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.aOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.aSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789214
Page 226 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.bOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.bSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789215
Page 227 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.cOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.cSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789216
Page 228 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.dOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.dSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789217
Page 229 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.eOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.eSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789218
Page 230 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1.fOct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
1.fSep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789219
Page 231 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Oct-29-2020 17:14:34 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-02-2020 10:46:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
2Oct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789220
Page 232 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Oct-02-2020 10:46:11 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-11-2020 11:14:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789221
Page 233 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789222
Page 234 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789223
Page 235 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789224
Page 236 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789225
Page 237 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789226
Page 238 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789227
Page 239 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Sep-11-2020 11:14:59 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789228
Page 240 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 11:16:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789229
Page 241 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-11-2020 11:16:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789230
Page 242 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-11-2020 11:16:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789231
Page 243 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-11-2020 11:16:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789232
Page 244 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-11-2020 11:16:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789233
Page 245 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789234
Page 246 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789235
Page 247 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789236
Page 248 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789237
Page 249 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789238
Page 250 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789239
Page 251 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789240
Page 252 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789241
Page 253 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789242
Page 254 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789243
Page 255 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789244
Page 256 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789245
Page 257 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789246
Page 258 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789247
Page 259 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789248
Page 260 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789249
Page 261 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789250
Page 262 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.dSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789251
Page 263 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.dSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789252
Page 264 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.dSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789253
Page 265 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.dSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789254
Page 266 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.eSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789255
Page 267 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.eSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789256
Page 268 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.eSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789257
Page 269 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.eSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789258
Page 270 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.fSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789259
Page 271 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.fSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789260
Page 272 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.fSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789261
Page 273 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.fSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789262
Page 274 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.gSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789263
Page 275 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.gSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789264
Page 276 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.gSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789265
Page 277 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.gSep-11-2020 11:16:26 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789266
Page 278 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789267
Page 279 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Sep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789268
Page 280 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Sep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789269
Page 281 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Sep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789270
Page 282 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Sep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789271
Page 283 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789272
Page 284 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789273
Page 285 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789274
Page 286 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.aSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789275
Page 287 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789276
Page 288 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789277
Page 289 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789278
Page 290 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.bSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789279
Page 291 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789280
Page 292 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5.cSep-11-2020 11:16:50 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d14\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0789281
Page 293 of 625
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911197 Subjec
…[truncated]