125742 S1 M5 CRF c4591001 1091 10911274

Document text

Page 1 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789919
Page 2 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789920
Page 3 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [10911274]
2.Birth Date: /1949
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0789921
Page 4 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789922
Page 5 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789923
Page 6 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789924
Page 7 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789925
Page 8 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [80.6]
3.Unit: kg
4.Height: [178.4]
5.Unit: cm
6.Body Mass Index: [25.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789926
Page 9 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [256549]
3.Randomization Group: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789927
Page 10 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BPYSP8]
5.bSample ID [BPR43Z]
5.cSample ID [BPR440]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789928
Page 11 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BPYSP1]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789929
Page 12 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/10/2020 12:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789930
Page 13 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789931
Page 14 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789932
Page 15 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789933
Page 16 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BP8LVH]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789934
Page 17 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/29/2020 09:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789935
Page 18 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789936
Page 19 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BRFH05]
5.bSample ID [BLG138]
5.cSample ID [BLG139]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789937
Page 20 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789938
Page 21 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789939
Page 22 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789940
Page 23 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789941
Page 24 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789942
Page 25 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789943
Page 26 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789944
Page 27 of 157
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789945
Page 28 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789946
Page 29 of 157
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Unplanned Assessments
1.Assessments
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789947
Page 30 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789948
Page 31 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789949
Page 32 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789950
Page 33 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789951
Page 34 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  periorbital angioe
dema Sep/11/2020 UNK:
UNK NO
End Date Time:
Sep/13/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  periorbital angioe
dema Sep/27/2020 UNK:
UNK NO
End Date Time:
Sep/28/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EV
ENT 3  pain at injection s
ite Dec/17/2020 UNK:
UNK NO
End Date Time:
Dec/18/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EV
ENT 4  headache  Dec/16/2020 14:00
 NO
End Date Time:
Dec/16/2020 14:30
 Repeating
Pages
 5.ADVERSE EV
ENT 5  fatigue  Jan/4/2021 16:00  NO
End Date Time:
Jan/5/2021 UNK:UNK
 Repeating
Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789952
Page 35 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[periorbital angioedema]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/13/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[seasonal allergies]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789953
Page 36 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789954
Page 37 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[periorbital angioedema]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[seasonal allergies]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789955
Page 38 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789956
Page 39 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[pain at injection site]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789957
Page 40 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789958
Page 41 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[headache]
4.Start Date Time: Dec/16/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/16/2020 14:30
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789959
Page 42 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789960
Page 43 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[fatigue]
4.Start Date Time: Jan/4/2021 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789961
Page 44 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789962
Page 45 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789963
Page 46 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789964
Page 47 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789965
Page 48 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: //
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789966
Page 49 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789967
Page 50 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789968
Page 51 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789969
Page 52 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789970
Page 53 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789971
Page 54 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789972
Page 55 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789973
Page 56 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789974
Page 57 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789975
Page 58 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789976
Page 59 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789977
Page 60 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789978
Page 61 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789979
Page 62 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789980
Page 63 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/16/2020
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789981
Page 64 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789982
Page 65 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/16/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789983
Page 66 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [BS3FM8]
5.bSample ID [BS3FM9]
5.cSample ID [BPYSBZ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789984
Page 67 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BPYSBW]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789985
Page 68 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: Dec/16/2020 13:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789986
Page 69 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789987
Page 70 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789988
Page 71 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789989
Page 72 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789990
Page 73 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BPYSKM]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789991
Page 74 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: Jan/4/2021 09:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789992
Page 75 of 157
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789993
Page 76 of 157
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/8/2021
3.Comments: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789994
Page 77 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789995
Page 78 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789996
Page 79 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789997
Page 80 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789998
Page 81 of 157
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0789999
Page 82 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0790000
Page 83 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0790001
Page 84 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0790002
Page 85 of 157
***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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-11-2020 14:06:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790003
Page 86 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormDec-16-2020 16:04:35 (UTC-05:00) Eastern
Time (US & Canada)All criteria met
Not Applicable
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790004
Page 87 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Dec-16-2020 13:44:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Samir Arora  Approved Nov-02-2020 12:49:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SamirArora, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790005
Page 88 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020 14:04:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-11-2020 14:04:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790006
Page 89 of 157
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020 14:05:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/10/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790007
Page 90 of 157
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 14:04:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10911274Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020 14:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-11-2020 14:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-11-2020 14:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020 14:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790008
Page 91 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020 14:06:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790009
Page 92 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail 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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020 14:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020 14:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020 14:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790010
Page 93 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.a
Date Location User Value Reason
Sep-11-2020 14:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:allergic rhinit
is
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020 14:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 14:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergic rhinitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-11-2020 14:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020 14:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790011
Page 94 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
80.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
178.4Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.3Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790012
Page 95 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790013
Page 96 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-11-2020 14:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-11-2020 14:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
256549Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790014
Page 97 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 14:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 14:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-12-2020 20:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-12-2020 03:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-11-2020 14:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-11-2020 14:17:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790015
Page 98 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Sep-12-2020 20:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYSP8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-12-2020 20:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYSP8Initial Entry
5.b
Date Location User Value Reason
Sep-12-2020 20:45:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR43ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-12-2020 20:45:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR43ZInitial Entry
5.c
Date Location User Value Reason
Sep-12-2020 20:59:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR440Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-12-2020 20:59:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR440Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790016
Page 99 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 14:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 14:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-12-2020 21:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-12-2020 03:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-11-2020 14:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-11-2020 14:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790017
Page 100 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Sep-12-2020 21:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYSP1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-12-2020 21:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYSP1Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790018
Page 101 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 12:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790019
Page 102 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-11-2020 14:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790020
Page 103 of 157
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020 14:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790021
Page 104 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 14:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790022
Page 105 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.6
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790023
Page 106 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790024
Page 107 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 14:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 14:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 15:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-02-2020 04:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
confirm if sample
was collected and
consider updating
associated barcode
at sample ID as
appropriate. Thank
you.
Oct-01-2020 14:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790025
Page 108 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020 14:42:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 15:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8LVHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 15:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8LVHInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790026
Page 109 of 157
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 09:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790027
Page 110 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-01-2020 14:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790028
Page 111 of 157
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020 11:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790029
Page 112 of 157
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 07:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-28-2020 06:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790030
Page 113 of 157
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Oct-28-2020 07:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFH05Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 07:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFH05Initial Entry
5.b
Date Location User Value Reason
Oct-28-2020 07:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG138Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 07:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLG138Initial Entry
5.c
Date Location User Value Reason
Oct-28-2020 07:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLG139Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 07:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLG139Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790031
Page 114 of 157
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
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: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020 11:00:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 11:00:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 11:00:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790032
Page 115 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790033
Page 116 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790034
Page 117 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790035
Page 118 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790036
Page 119 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790037
Page 120 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
periorbital angioedemaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/13/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790038
Page 121 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
seasonal allergiesInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790039
Page 122 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-01-2020 14:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790040
Page 123 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
periorbital angioedemaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790041
Page 124 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-01-2020 14:47:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
seasonal allergiesTranscription Error
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790042
Page 125 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020 14:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 14:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDTranscription Error
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE periorbital
angioedema: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790043
Page 126 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-01-2020 14:46:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790044
Page 127 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790045
Page 128 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790046
Page 129 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-01-2021 15:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790047
Page 130 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/16/2020 14:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790048
Page 131 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790049
Page 132 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-01-2021 15:28:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790050
Page 133 of 157
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
fatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/5/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790051
Page 134 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790052
Page 135 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-01-2021 15:29:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790053
Page 136 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021 10:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-28-2020 15:02:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-28-2020 15:02:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/14/2020Transcription Error
Dec-28-2020 14:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per source
documents, initial
contact was on
14-Dec-2020.
Please review and
reconcile.
Dec-16-2020 13:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790054
Page 137 of 157
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-17-2020 08:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 04:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-16-2020 13:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-16-2020 13:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790055
Page 138 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 16:04:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790056
Page 139 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-16-2020 16:04:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/16/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790057
Page 140 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-16-2020 16:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 16:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 16:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790058
Page 141 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 16:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 16:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 09:28:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 04:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 16:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 16:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790059
Page 142 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Dec-17-2020 09:28:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3FM8Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 09:28:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS3FM8Initial Entry
5.b
Date Location User Value Reason
Dec-17-2020 09:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS3FM9Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 09:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS3FM9Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020 09:29:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYSBZInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 09:29:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYSBZInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790060
Page 143 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 09:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 04:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790061
Page 144 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Dec-17-2020 09:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYSBWInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 09:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYSBWInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790062
Page 145 of 157
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020 13:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790063
Page 146 of 157
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-16-2020 16:06:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790064
Page 147 of 157
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020 08:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020 08:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790065
Page 148 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021 11:30:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790066
Page 149 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 11:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 11:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-04-2021 15:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-04-2021 11:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 11:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
5.a
Date Location User Value Reason
Jan-04-2021 15:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYSKMInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790067
Page 150 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Jan-04-2021 15:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYSKMInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790068
Page 151 of 157
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 09:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790069
Page 152 of 157
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-04-2021 11:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790070
Page 153 of 157
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021 02:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 13:56:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-18-2021 06:46:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Feb-17-2021 10:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790071
Page 154 of 157
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-17-2021 10:31:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-17-2021 10:31:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Feb/8/2021Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
   
(b) (4)
FDA-CBER-2021-5683-0790072
Page 155 of 157
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-22-2021
23:38:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedIncorrect query
Feb-18-2021
23:22:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7314737;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-18-2021
13:52:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/8/
2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-18-2021 13:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-18-2021 13:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
   
(b) (4)
FDA-CBER-2021-5683-0790073
Page 156 of 157
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020 11:00:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-11-2020 14:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-11-2020 14:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-27-2020 11:00:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-11-2020 14:16:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-11-2020 14:06:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0790074
Page 157 of 157
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911274 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020 12:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Samir
AroraData Entry:
Click Here to EnableInitial Entry
090177e196d89029\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
   
(b) (4)
FDA-CBER-2021-5683-0790075