Document text
Page 1 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790701
Page 2 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790702
Page 3 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10911300]
2.Birth Date: /1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790703
Page 4 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790704
Page 5 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790705
Page 6 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790706
Page 7 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[endometrial ablation]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[menorrhagia]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
Dec/UNK/2019
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790707
Page 8 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Reduction Mammoplasty (breast reduction)]
Start Date: Dec/UNK/2018
Ongoing: NO
End Date:
Dec/UNK/2018
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bilateral carpal tunnel release]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bilateral carpal tunnel syndrome]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790708
Page 9 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Broken jaw]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[broken jaw repair surgery]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[occasional migraines]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790709
Page 10 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [87.5]
3.Unit: kg
4.Height: [162.3]
5.Unit: cm
6.Body Mass Index: [33.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790710
Page 11 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790711
Page 12 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [89865]
3.Randomization Group: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790712
Page 13 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BPYSSN]
5.bSample ID [BPR45T]
5.cSample ID [BPR45V]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790713
Page 14 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BPYSSH]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790714
Page 15 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 10:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790715
Page 16 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790716
Page 17 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790717
Page 18 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790718
Page 19 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790719
Page 20 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8LYN]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790720
Page 21 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/6/2020 09:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790721
Page 22 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790722
Page 23 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFH44]
5.bSample ID [BSGXV8]
5.cSample ID [BSGXV9]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790723
Page 24 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790724
Page 25 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790725
Page 26 of 191
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790726
Page 27 of 191
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790727
Page 28 of 191
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790728
Page 29 of 191
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790729
Page 30 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790730
Page 31 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790731
Page 32 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790732
Page 33 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790733
Page 34 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790734
Page 35 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790735
Page 36 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790736
Page 37 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790737
Page 38 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790738
Page 39 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790739
Page 40 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790740
Page 41 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790741
Page 42 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790742
Page 43 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790743
Page 44 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 soreness at inj
ection site Sep/16/2020
UNK:UNK NO
End Date Time:
Sep/17/2020 UNK
:UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Chills Oct/6/2020 21
:30 NO
End Date Time:
Oct/7/2020 08:00
Repeating
Pages
3.ADVERSE
EVENT 3 Injection Site
Pain Oct/6/2020 13
:00 NO
End Date Time:
Oct/7/2020 UNK:
UNK
Repeating
Pages
4.ADVERSE
EVENT 4 Appendicitis Oct/21/2020
UNK:UNK NO
End Date Time:
Oct/22/2020 05:55
Repeating
Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790744
Page 45 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[soreness at injection site]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/17/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790745
Page 46 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790746
Page 47 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790747
Page 48 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chills]
4.Start Date Time: Oct/6/2020 21:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 08:00
6.Toxicity Grade: 1
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790748
Page 49 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790749
Page 50 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790750
Page 51 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Injection Site Pain]
4.Start Date Time: Oct/6/2020 13:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790751
Page 52 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790752
Page 53 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790753
Page 54 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Appendicitis]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/22/2020 05:55
6.Toxicity Grade: 4
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790754
Page 55 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Inflammation of Appendix, Unknown Cause]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790755
Page 56 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant
Medication given?NO
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[2020437759]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790756
Page 57 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790757
Page 58 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790758
Page 59 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO influenza v
accine Oct/27/
2020 Repeating
Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790759
Page 60 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[influenza vaccine]
5.Date: Oct/27/2020
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790760
Page 61 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790761
Page 62 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790762
Page 63 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790763
Page 64 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790764
Page 65 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790765
Page 66 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790766
Page 67 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790767
Page 68 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790768
Page 69 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790769
Page 70 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790770
Page 71 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790771
Page 72 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790772
Page 73 of 191
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790773
Page 74 of 191
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790774
Page 75 of 191
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790775
Page 76 of 191
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790776
Page 77 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790777
Page 78 of 191
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790778
Page 79 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790779
Page 80 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790780
Page 81 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790781
Page 82 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790782
Page 83 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790783
Page 84 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790784
Page 85 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-15-2020 15:51:06 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790785
Page 86 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-18-2021 10:27:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Samir
Arora Approved Nov-17-2020 10:15:40 (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.
N/A Nov-12-2020 11:15:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790786
Page 87 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
N/A
Samir
Arora Approved Nov-12-2020 08:55:15 (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.
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790787
Page 88 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-15-2020
15:49:16
(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-15-2020
15:49:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790788
Page 89 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-15-2020
15:49:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/15/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790789
Page 90 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-15-2020
15:48:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10911300Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-15-2020
15:48:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-15-2020
15:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790790
Page 91 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-15-2020
15:49:57
(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-15-2020
15:49:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790791
Page 92 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020
15:50:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790792
Page 93 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-15-2020
15:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020
15:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020
15:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790793
Page 94 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-15-2020
15:53:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:allergic r
hinitis
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-15-2020
15:53:26
(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-15-2020
15:53:26
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
allergic rhinitisInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790794
Page 95 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-15-2020
15:53:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-15-2020
15:53:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-15-2020
15:56:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:endometria
l ablation
Start Date
:Dec/UNK/
2019Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790795
Page 96 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date
:
Dec/U
NK/201
9
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790796
Page 97 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Sep-15-2020
15:56:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
15:56:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
endometrial ablationInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-15-2020
15:56:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-15-2020
15:56:25ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790797
Page 98 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Dec/UNK/2019
1.c
Date Location User Value Reason
Sep-15-2020
15:57:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:menorrhag
ia
Start Date
:UNK/UN
K/2015
Ongoing: NO
End Dat
e:
Dec/U
NK/20
19Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790798
Page 99 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Sep-15-2020
15:57:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
15:57:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
menorrhagiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-15-2020
15:57:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-15-2020
15:57:19ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790799
Page 100 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Dec/UNK/2019
1.d
Date Location User Value Reason
Sep-15-2020
15:58:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:4
Medica
l Histo
ry Ter
m:Reduction Ma
mmoplasty (br
east reduction
)
Start D
ate:Dec/UNK/201
8
Ongoin
g:NO
End Date:
Dec/UNK/
2018Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790800
Page 101 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Sep-15-2020
15:58:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
15:58:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Reduction Mammopl
asty (breast reduction
)Initial Entry
1.d Start Date:
Date Location User Value Reason
Sep-15-2020
15:58:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-15-2020
15:58:47ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790801
Page 102 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Dec/UNK/2018
1.e
Date Location User Value Reason
Sep-15-2020
15:59:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:Bilateral car
pal tunnel re
lease
Start Da
te:UNK/UNK/
2011
Ongoing
:NO
End Date:
UNK/UN
K/2011Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790802
Page 103 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e Line/MH Number:
Date Location User Value Reason
Sep-15-2020
15:59:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
15:59:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bilateral carpal tunne
l releaseInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-15-2020
15:59:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-15-2020
15:59:54ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790803
Page 104 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2011
1.f
Date Location User Value Reason
Sep-15-2020
16:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:6
Medical
History
Term:Bilateral car
pal tunnel sy
ndrome
Start Da
te:UNK/UNK/2
005
Ongoing
:NO
End Date:
UNK/UN
K/2011Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790804
Page 105 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Sep-15-2020
16:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
16:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Bilateral carpal tunne
l syndromeInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-15-2020
16:21:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-15-2020
16:21:04ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790805
Page 106 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2011
1.g
Date Location User Value Reason
Sep-15-2020
16:22:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:Broken ja
w
Start Date
:UNK/UN
K/1992
Ongoing: NO
End Date
:
UNK/U
NK/199
2Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790806
Page 107 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.g Line/MH Number:
Date Location User Value Reason
Sep-15-2020
16:22:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
16:22:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Broken jawInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-15-2020
16:22:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-15-2020
16:22:34ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790807
Page 108 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1992
1.h
Date Location User Value Reason
Sep-15-2020
16:29:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:broken jaw
repair surge
ry
Start Dat
e:UNK/UNK/
1992
Ongoing: NO
End Date:
UNK/U
NK/199
2Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790808
Page 109 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.h Line/MH Number:
Date Location User Value Reason
Sep-15-2020
16:29:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
16:29:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
broken jaw repair sur
geryInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-15-2020
16:29:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-15-2020
16:29:55ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790809
Page 110 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1992
1.i
Date Location User Value Reason
Sep-15-2020
16:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical Hi
story Term
:occasiona
l migraine
s
Start Date: UNK/UN
K/1995
Ongoing: YESInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790810
Page 111 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.i Line/MH Number:
Date Location User Value Reason
Sep-15-2020
16:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020
16:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
occasional migrainesInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-15-2020
16:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-15-2020
16:31:22ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790811
Page 112 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790812
Page 113 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
87.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790813
Page 114 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
162.3Initial Entry
5. Unit:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.2Initial Entry
7.a
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.6Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790814
Page 115 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790815
Page 116 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
16:32:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790816
Page 117 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790817
Page 118 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790818
Page 119 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020
16:34:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790819
Page 120 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-15-2020
16:34:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-15-2020
16:34:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
89865Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790820
Page 121 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020
16:34:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020
16:34:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020
13:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
05:41:05
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790821
Page 122 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-15-2020
16:34:48
(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-15-2020
16:34:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020
13:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPYSS
NInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790822
Page 123 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-21-2020
13:10:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYSSNInitial Entry
5.b
Date Location User Value Reason
Sep-21-2020
13:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPR45
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-21-2020
13:11:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPR45TInitial Entry
5.c
Date Location User Value Reason
Sep-21-2020
13:11:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPR45
VInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790823
Page 124 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Sep-21-2020
13:11:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPR45VInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790824
Page 125 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020
16:35:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020
16:35:14
(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-21-2020
13:11:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-16-2020
05:41:05
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790825
Page 126 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-15-2020
16:35:14
(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-15-2020
16:35:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020
13:11:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPYSS
HInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790826
Page 127 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-21-2020
13:11:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYSSHInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790827
Page 128 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790828
Page 129 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 10:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020
16:36:16
(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-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790829
Page 130 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-15-2020
16:36:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790830
Page 131 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-15-2020
16:36:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790831
Page 132 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
08:22:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790832
Page 133 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790833
Page 134 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020
08:23:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790834
Page 135 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790835
Page 136 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790836
Page 137 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020
08:23:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790837
Page 138 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
08:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
08:24:00
(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-07-2020
09:54:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-07-2020
09:24:16
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790838
Page 139 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
08:24:00
(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-07-2020
08:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
09:54:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP8LY
NInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790839
Page 140 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020
09:54:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP8LYNInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790840
Page 141 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790841
Page 142 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 09:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790842
Page 143 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-07-2020
08:25:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790843
Page 144 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020
13:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies
query
Nov-12-2020
11:15:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Nov-11-2020
22:46:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Please
consider
adding
influenza
vaccine
reported
during V3 to
conmed log in
inform
Nov-06-2020
10:49:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790844
Page 145 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020
10:49:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020
10:49:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
11:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-06-2020
10:49:09
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790845
Page 146 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-06-2020
10:49:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020
11:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRFH4
4Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020
11:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRFH44Initial Entry
5.b
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790846
Page 147 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-06-2020
11:50:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSGXV
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020
11:50:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGXV8Initial Entry
5.c
Date Location User Value Reason
Nov-06-2020
11:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BSGXV
9Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020
11:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGXV9Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790847
Page 148 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-06-2020
10:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-06-2020
10:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-06-2020
10:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790848
Page 149 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790849
Page 150 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790850
Page 151 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790851
Page 152 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790852
Page 153 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020
08:28:08
(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-07-2020
08:28:08
(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-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
soreness at injection s
iteInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790853
Page 154 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/17/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
08:28:08
(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).
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790854
Page 155 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020
08:28:08
(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-07-2020
08:28:08
(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-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020
08:28:20
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790855
Page 156 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020
08:28:08
(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-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790856
Page 157 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-07-2020
08:28:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790857
Page 158 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020
11:36:57
(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
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ChillsInitial Entry
4. Start Date Time:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790858
Page 159 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 21:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/7/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020
11:36:57
(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
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790859
Page 160 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
prevent above outcomes).
Date Location User Value Reason
Nov-06-2020
11:36:57
(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
Nov-06-2020
11:36:57
(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
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790860
Page 161 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
11:36:57
(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
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790861
Page 162 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
11:36:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790862
Page 163 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020
11:38:28
(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
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site PainInitial Entry
4. Start Date Time:
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790863
Page 164 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020 13:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/7/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020
11:38:28
(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
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790864
Page 165 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-06-2020
11:38:28
(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
Nov-06-2020
11:38:28
(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
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790865
Page 166 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
11:38:28
(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
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790866
Page 167 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
11:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790867
Page 168 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020
11:43:01
(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
Mar-10-2021
22:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-10-2021
13:09:22ACV0PFEINFP6000 Query 1: Answere
dPer
coordinator,
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790868
Page 169 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)SAE report has
been updated.
Mar-05-2021
21:30:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedClinical -
Thank you;
please update
the WBC count
in the SAE
report
Mar-04-2021
12:57:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dWBC was
elevated at 15,
not low at 1.5.
Leukocytosis
and elevated
neutrophil
counts
consistent with
appendicitis.
Mar-04-2021
12:13:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - SAE
report states
WBC count
was 1.5 x10(3)
(nl 4-10.5), and
neutrophil
count was
higher at 10.3
x10(3) (nl
2-7.3). Please
review WBC
count result
(does the
subject have
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790869
Page 170 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
leucopenia) or
update SAE as
appropriate
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021
22:38:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-11-2021
15:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Mar-11-2021
15:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 UNK:
UNKChanged
Information
Mar-11-2021
12:11:00
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 1: Opened Clinical - Start
date is
22Oct2020;
however
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790870
Page 171 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) 09Mar21 SAE
update reports
start date of
21Oct2020.
Please review,
harmonize
reporting, and
update where
applicable
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021
22:55:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-09-2021
16:45:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Mar-09-2021
16:45:00
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NO
End Date Time:New
Information
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790871
Page 172 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) Oct/22/2020 05:
55
Mar-04-2021
12:11:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical End
date is
23Oct2020;
however, SAE
report has an
end date of
22Oct2020.
Please review,
harmonize
reporting, and
update where
applicable
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/23/2020 05:
00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790872
Page 173 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
Nov-10-2020
02:12:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
DeletedClose Auto Query
Nov-10-2020
02:12:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse satisfies query
Nov-09-2020
13:24:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
ClosedClose Auto Query
Nov-09-2020
13:24:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Is this s
erious e
vent assChanged Information
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790873
Page 174 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
ociated
with co
ngenital
anomaly
or birth
defect?
NO
Did this
serious
event re
sult in d
eath?
NO
Did this
serious
event re
quire or
prolong
hospitali
zation?
NO
Did this
serious
event re
sult in p
ersistent
or signif
icant dis
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790874
Page 175 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
ability/i
ncapacit
y?
NO
Is this s
erious e
vent life
threaten
ing?
YES
Other m
edically
importa
nt serio
us event
NO
Nov-09-2020
12:53:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse satisfies query
Nov-09-2020
11:43:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4:
OpenedIs this adverse event
serious?' is reported 'Yes',
but at least one seriousness
criteria is missing. Please
review and update as
appropriate.
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790875
Page 176 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-09-2020
11:43:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
CandidateFor AE Appendicitis:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Nov-09-2020
11:43:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredChanged Information
Nov-09-2020
11:43:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredChanged Information
Nov-09-2020
11:43:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
YES
Is this s
erious e
vent ass
ociated
with co
ngenital
anomaly
or birth
defect?
NOChanged Information
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790876
Page 177 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Did this
serious
event re
sult in d
eath?
NO
Did this
serious
event re
sult in p
ersistent
or signif
icant dis
ability/i
ncapacit
y?
NO
Is this s
erious e
vent life
threaten
ing?
NO
Nov-08-2020
18:32:01
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query 2:
OpenedClinical - Event of
appendicitis is recorded as
life-threatening on the SAE
form; this is a criterion
which makes an outpatient
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790877
Page 178 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Canada) event reportable as serious.
Please clarify the level of
severity and whether this
event is serious; & update
as appropriate.
Nov-07-2020
11:55:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
OpenedSAE
RECON:AER#2020437759
APPENDICITIS(onset
date:22Oct2020)was
reported as serious in
Safety database but non
serious in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790878
Page 179 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
Inflammation of
Appendix, Unkn
own CauseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790879
Page 180 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
11:43:01
(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
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
11:43:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790880
Page 181 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-10-2020
02:12:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020437759Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0790881
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790882
Page 183 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790883
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
influenza vaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-12-2020
11:15:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0790884
Page 185 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
10:27:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790885
Page 186 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021
10:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
10:27:58
(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.
Feb-18-2021
10:27:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at VInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790886
Page 187 of 191
***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
Site No: 1091 Site Name: (1091) Aventiv Research Inc.
Subject No: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
accination 1/2
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790887
Page 188 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021
10:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-18-2021
10:28:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0790888
Page 189 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-06-2020
10:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-15-2020
16:34:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-15-2020
15:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020
10:49:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
Sep-15-2020
16:34:32ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790889
Page 190 of 191
***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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-15-2020
15:51:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0790890
Page 191 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10911300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-12-2020
08:55:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Samir
AroraData Entry:
Click Here to EnableInitial Entry
090177e196ae3d11\Final\Final On: 01-Apr-2021 04:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0790891