Document text
Page 1 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963386
Page 2 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963387
Page 3 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10871121]
2.Birth Date: /1953
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963388
Page 4 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963389
Page 5 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963390
Page 6 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963391
Page 7 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INSOMNIA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Esophageal Ulcers]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Esophageal varices]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alcoholic Cirrhosis]
Start Date: UNK/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963392
Page 8 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [73.75]
3.Unit: kg
4.Height: [177.8]
5.Unit: cm
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963393
Page 9 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [233107]
3.Randomization Group: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963394
Page 10 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1JPS]
5.bSample ID [BP1JPT]
5.cSample ID [BP1JPV]
5.dSample ID [BPHBX3]
5.eSample ID [BPHBF8]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963395
Page 11 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1JN9]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963396
Page 12 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 14:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963397
Page 13 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963398
Page 14 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963399
Page 15 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963400
Page 16 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963401
Page 17 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963402
Page 18 of 169
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963403
Page 19 of 169
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963404
Page 20 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963405
Page 21 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963406
Page 22 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963407
Page 23 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963408
Page 24 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963409
Page 25 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963410
Page 26 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963411
Page 27 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963412
Page 28 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963413
Page 29 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963414
Page 30 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963415
Page 31 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963416
Page 32 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963417
Page 33 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963418
Page 34 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963419
Page 35 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963420
Page 36 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/9/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963421
Page 37 of 169
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/9/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963422
Page 38 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963423
Page 39 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963424
Page 40 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 GI Bleed Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Worsening of esophageal
ulcers Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Worsening of esophageal
varices Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 Hypernatremia Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 Thrombocytopenia Sep/7/2020 UNK:
UNK YES Repeating
Pages
6.ADVERSE EV
ENT 6 Worsening of alcoholic ci
rrhosis Sep/7/2020 UNK:
UNK YES Repeating
Pages
7.ADVERSE EV
ENT 7 Hematochezia Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
8.ADVERSE EV
ENT 8 Acute blood loss anemia Sep/7/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
Repeating
Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963425
Page 41 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[GI Bleed]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Due to Ulcers]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963426
Page 42 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020359856]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963427
Page 43 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of esophageal ulcers]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Worsening of previous condition]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963428
Page 44 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963429
Page 45 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[Worsening of esophageal varices]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Worsening of previous condition]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963430
Page 46 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963431
Page 47 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[Hypernatremia]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Spontaneous event]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963432
Page 48 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963433
Page 49 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Thrombocytopenia]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Due to cirrhosis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963434
Page 50 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963435
Page 51 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of alcoholic cirrhosis]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Worsening of previous condition]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963436
Page 52 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963437
Page 53 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hematochezia]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Due to ulcers]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963438
Page 54 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963439
Page 55 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute blood loss anemia]
4.Start Date Time: Sep/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[due to varices]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963440
Page 56 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963441
Page 57 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963442
Page 58 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963443
Page 59 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963444
Page 60 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963445
Page 61 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963446
Page 62 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963447
Page 63 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963448
Page 64 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963449
Page 65 of 169
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963450
Page 66 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963451
Page 67 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963452
Page 68 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963453
Page 69 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963454
Page 70 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963455
Page 71 of 169
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963456
Page 72 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963457
Page 73 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963458
Page 74 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963459
Page 75 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963460
Page 76 of 169
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963461
Page 77 of 169
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963462
Page 78 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963463
Page 79 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963464
Page 80 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963465
Page 81 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/9/2020
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963466
Page 82 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963467
Page 83 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin Cannon Approved Nov-16-2020 18:45:49 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963468
Page 84 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-20-2020 16:52:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963469
Page 85 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 10:49:00 (UTC-05:00) Eastern Time
(US & Canada)Subject discontinued on 15/Sep/2020
Not Done
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963470
Page 86 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-20-2020 10:49:00 (UTC-05:00) Eastern Time
(US & Canada)Subject discontinued on 15/Sep/2020
Not Done
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963471
Page 87 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 10:49:00 (UTC-05:00) Eastern Time
(US & Canada)Subject discontinued on 15/Sep/2020
Not Done
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963472
Page 88 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-16-2020 15:13:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963473
Page 89 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-16-2020 15:13:48 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963474
Page 90 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin Cannon Approved Nov-16-2020 18:45:49 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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-16-2020 15:13:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon Approved Nov-13-2020 14:03:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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-11-2020 14:58:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon Approved Oct-27-2020 17:48:06 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963475
Page 91 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, 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 Oct-26-2020 16:11:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon Approved Oct-21-2020 17:25:18 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963476
Page 92 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 16:51:11
(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
Aug-20-2020 16:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963477
Page 93 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 16:51:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963478
Page 94 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-29-2020 07:44:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Sep-25-2020 11:09:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject failed to report the
following conditions at V1.
Upon review of hospital
records, please unfreeze
Med Hx eCRF so terms
may be added:
ESOPHAGEAL ULCERS,
ESOPHAGEAL
VARICES, ALCHOLIC
CIRRHOSIS,
GASTROESOPHAGEAL
REFLUX DISEASE.
Sep-24-2020 05:17:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed EVENT ADDED IN AE
CRF
Sep-22-2020 13:58:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery Based on
history (newly learned) of
cirrhosis and varices,
consider subject's
eligibility with respect to
Inclusion #3/Exclusion #1,
and update if applicable
Sep-22-2020 11:10:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate ClinQuery Based on
history (newly learned) of
cirrhosis and varices,
consider subject's
eligibility with respect to
Inclusion #3/Exclusion #1,
and update if applicable
Sep-18-2020 06:28:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020359856
GI Bleeding(onset
date:07Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963479
Page 95 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-20-2020 16:50:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc (autocalc) Data Entry:
10871121Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 16:50:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 16:52:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 16:52:25
(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
Aug-20-2020 16:52:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963480
Page 96 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 16:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963481
Page 97 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 16:52:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 16:52:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 16:52:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963482
Page 98 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 16:56:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:INSOMNIA
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020 16:56:19
(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-23-2020 14:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-23-2020 11:39:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered DATA UPDATED
PER QUERY.
Sep-17-2020 11:28:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery Please
update medical
history with
additional conditions
reported in the SAE
hospitalization report
which had been
previously
unreported by
subject
Aug-20-2020 16:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
INSOMNIAInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963483
Page 99 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.a Start Date:
Date Location User Value Reason
Aug-20-2020 16:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020 16:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-23-2020 11:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Esophageal Ulc
ers
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963484
Page 100 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020 11:37:50
(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-23-2020 11:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Esophageal UlcersInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020 11:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020 11:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-23-2020 11:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Esophageal vari
ces
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963485
Page 101 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 11:39:12
(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-23-2020 11:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Esophageal varicesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 11:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 11:39:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-23-2020 11:40:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Alcoholic Cirrh
osis
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0963486
Page 102 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Line/MH Number:
Date Location User Value Reason
Sep-23-2020 11:40:07
(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-23-2020 11:40:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Alcoholic CirrhosisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-23-2020 11:40:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-23-2020 11:40:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-23-2020 11:40:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:GERD
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963487
Page 103 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e Line/MH Number:
Date Location User Value Reason
Sep-23-2020 11:40:25
(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-23-2020 11:40:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-23-2020 11:40:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-23-2020 11:40:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963488
Page 104 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
73.75Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
177.8Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3Initial Entry
7.a
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963489
Page 105 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 37.2
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 16:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963490
Page 106 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 16:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 16:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
233107Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963491
Page 107 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 16:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 16:54:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 08:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 03:12:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-20-2020 16:54:28
(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.
Aug-20-2020 16:54:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963492
Page 108 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-21-2020 08:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1JPSInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 08:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1JPSInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 08:51:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1JPTInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 08:51:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1JPTInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 08:51:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1JPVInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 08:51:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1JPVInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020 08:51:44
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BPHBX3Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963493
Page 109 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 08:51:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHBX3Initial Entry
5.e
Date Location User Value Reason
Aug-21-2020 08:51:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHBF8Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 08:51:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHBF8Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963494
Page 110 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 16:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 16:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 08:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 03:12:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-20-2020 16:54:33
(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.
Aug-20-2020 16:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963495
Page 111 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-21-2020 08:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1JN9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 08:52:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1JN9Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963496
Page 112 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/19/2020 14:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963497
Page 113 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 16:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963498
Page 114 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 16:54:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963499
Page 115 of 169
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 05:35:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed as Subject
discontinued on
15/SEP/2020.
Oct-21-2020 16:53:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Confirming Visit 2
was not completed
for this subject.
Subject discontinued
from study on
15-Sep-2020. Kindly
refer to FUP eCRF
folder/form.
Oct-21-2020 07:33:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Kindly review
and complete, 'Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
Oct-20-2020 10:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject discontinued
on 15/SEP/2020
Oct-20-2020 10:49:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Oct-19-2020 06:57:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
Oct-08-2020 16:20:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0963500
Page 116 of 169
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-08-2020 16:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Re-issued query
under candidate
status.
Sep-25-2020 04:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
2. Erroneous Visit
Date Location User Value Reason
Oct-20-2020 10:49:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963501
Page 117 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 12:06:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Changed Information
Nov-12-2020 02:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Nov-11-2020 14:58:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-11-2020 14:58:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020Changed Information
Nov-10-2020 21:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The discontinuation
date of 15SEP2020
should be relative to
the AE causing the
the withdrawal of the
study vaccine, AE
start 07SEP2020 and
end 09SEP2020 (date
should not be after
the AE ended).
Please adjust
Discontinuation date.
Oct-09-2020 09:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 09:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0963502
Page 118 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-09-2020 09:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963503
Page 119 of 169
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 12:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Changed Information
Nov-12-2020 02:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Nov-11-2020 14:59:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-11-2020 14:59:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020Changed Information
Nov-10-2020 21:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The discontinuation
date of 15SEP2020
should be relative to
the AE causing the
the withdrawal of the
study vaccine, AE
start 07SEP2020 and
end 09SEP2020 (date
should not be after
the AE ended).
Please adjust
Discontinuation date.
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0963504
Page 120 of 169
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-09-2020 09:26:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
ADVERSE EVENT
but "Specify Status"
is Provided.
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-09-2020 09:26:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subject discontinued due to SA
EInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963505
Page 121 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963506
Page 122 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963507
Page 123 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963508
Page 124 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963509
Page 125 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963510
Page 126 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963511
Page 127 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963512
Page 128 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963513
Page 129 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 12:43:35
(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-09-2020 16:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-09-2020 09:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Kindly refer to
AE#8 "Acute Blood
Loss Anemia"
Sep-29-2020 08:30:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY
Consider an
additional AE of
Anemia, caused by
GI bleed, with SAE
report reporting
discharge HCT of
21.4.
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GI BleedInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963514
Page 130 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:42:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359672;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
12:43:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 12:43:35
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963515
Page 131 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-30-2020 19:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-29-2020 14:26:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE FUP report
faxed on
28-Oct-2020 at 14:23
from Site with latest
action taken with IP
updated accordingly
in latest report.
Oct-27-2020 22:20:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Thank you. SAE
report currently
reports action with
respect to study drug
is 'not applicable';
please update with
current action of
withdrawn due to AE
Oct-26-2020 16:49:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered A follow up safety
report was
submitted. Last
action taken with
study vaccine is
withdrawn, there is
not an option for
temporarily
withdrawn or
permanently
withdrawn per study
team email. Please
advise if further
clarification is
needed.
Oct-23-2020 20:37:59
(UTC-05:00) EasternACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963516
Page 132 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020359856] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Sep-24-2020 05:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE GI Bleed:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963517
Page 133 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
NO
Other medically important seri
ous 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.
Date Location User Value Reason
Sep-23-2020 12:43:35
(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
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Due to UlcersInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 14:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNChanged Information
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963518
Page 134 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 12:43:35
(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
Sep-23-2020 12:43:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 15:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Oct-13-2020 14:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered updated to drug
withdrawn
Oct-09-2020 09:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Opened CLINQUERY:
Thanks, please also
review the entry for
'Last Action Taken
with Study
Treatment' for this
event of GI Bleed,
since you indicate
treatment was also
discontinued.
Oct-09-2020 09:28:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Discontinued status
updated in EOT and
Follow Up eCRF
Oct-09-2020 09:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 09:34:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY: Data
indicates this AE led
to discontinuation
from study i.e. no
follow up to
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963519
Page 135 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
continue. However, it
is not indicated that
treatment was
discontinued. Please
review entry and
clarify subject's
status in trial.
Sep-24-2020 00:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Did the adverse
event cause the
subject to be
discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as
''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued from
the study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as
''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-23-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-24-2020 05:17:36
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
2020359856Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0963520
Page 136 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0963521
Page 137 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:00:12
(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
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Worsening of esophageal ulcersInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:44:58
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963522
Page 138 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada)
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359669;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
13:00:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963523
Page 139 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:00:12
(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
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Worsening of previous conditi
onInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0963524
Page 140 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:00:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963525
Page 141 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:15:36
(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
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Worsening of esophageal varicesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:45:13
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963526
Page 142 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada)
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359670;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
13:15:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963527
Page 143 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:15:36
(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
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Worsening of previous conditi
onInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963528
Page 144 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:15:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963529
Page 145 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:18:08
(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
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypernatremiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:45:32
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963530
Page 146 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada)
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359667;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
13:18:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963531
Page 147 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:18:08
(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
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Spontaneous eventInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:18:08
(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
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963532
Page 148 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:18:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963533
Page 149 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ThrombocytopeniaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 00:24:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-12-2020 15:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered correct, ongoing at
time of
discontinuation.
Nov-12-2020 12:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963534
Page 150 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ongoing. Please
review and update as
appropriate.
Nov-12-2020 00:24:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 15:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Still ongoing at time
of subject
discontinuation.
Nov-11-2020 14:59:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-10-2020 06:22:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-09-2020 09:29:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Confirmed ongoing
as of last date of
contact
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Sep-23-2020 13:20:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963535
Page 151 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:20:12
(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
Sep-23-2020 13:20:12
(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
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Due to cirrhosisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963536
Page 152 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:20:12
(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
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:20:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963537
Page 153 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Worsening of alcoholic cirrhosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 00:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-12-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered correct, ongoing at
time of
discontinuation.
Nov-12-2020 12:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963538
Page 154 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ongoing. Please
review and update as
appropriate.
Nov-12-2020 07:42:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 15:03:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Still ongoing at time
of subject
discontinuation.
Nov-11-2020 14:59:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-10-2020 06:22:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-09-2020 09:29:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Confirmed ongoing
as of last date of
contact
Oct-09-2020 09:25:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Sep-23-2020 13:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963539
Page 155 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:27:54
(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
Sep-23-2020 13:27:54
(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
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Worsening of previous conditi
onInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963540
Page 156 of 169
***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
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:27:54
(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
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:27:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963541
Page 157 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HematocheziaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:46:07
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963542
Page 158 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada)
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359671;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
13:32:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963543
Page 159 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:32:13
(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
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
Due to ulcersInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:32:13
(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
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963544
Page 160 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:32:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963545
Page 161 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Acute blood loss anemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Nov-12-2020
15:46:24
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Ans
wereddate updated.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963546
Page 162 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada)
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359668;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-23-2020
13:33:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
Se
p/9
/20
20
U
N
K:
U
N
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963547
Page 163 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
Sep-23-2020 13:33:41
(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
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
due to varicesInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 13:33:41
(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
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963548
Page 164 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 13:33:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963549
Page 165 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Withdrawal of Consent Date :
Date Location User ValueReason
Nov-16-2020
18:03:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Steven Finegan Prod Query
2: Clo
sedResponse satisfies query
Nov-16-2020
15:13:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
Nov-16-2020
15:13:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredSubject discontinued as of
09-Sep-2020 due to
Adverse Event. Withdrawal
of Consent is Not
Applicable.
Nov-14-2020
01:04:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedDM: Please mark this form
as Not applicable or else
clarify. Thank you.
Nov-12-2020
21:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_20
Nov-12-2020
16:12:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredSubject dropped per PI
discretion, not a withdrawal
of consent.
Nov-12-2020
16:12:46
(UTC-05:00)ACV0PFEINFP6000 Data
Entry
:Subject dropped per PI
discretion, not a withdrawal
of consent.
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0963550
Page 166 of 169
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time
(US &
Canada)
Nov-12-2020
16:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dThe form is unfrozen.
Please review and update as
necessary.
Nov-12-2020
12:06:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredPlease unfreeze
Nov-11-2020
18:36:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW5359675;‘Withdrawal
of Consent Date' is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Oct-26-2020
16:11:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Sep/1
5/202
0Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963551
Page 167 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 09:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-09-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-20-2020 16:54:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-20-2020 16:52:57
(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-12-2020 12:06:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/9/2020Changed Information
Nov-12-2020 12:05:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/9/2020Changed Information
Nov-11-2020 14:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/7/2020Changed Information
Nov-11-2020 14:58:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Changed Information
Oct-09-2020 09:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Oct-09-2020 09:25:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Aug-20-2020 16:54:51
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963552
Page 168 of 169
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Aug-20-2020 16:52:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963553
Page 169 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 17:24:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Kevin
CannonData Entry:
Click Here to EnableInitial Entry
090177e196ae4037\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963554