125742 S1 M5 CRF c4591001 1088 10881139

Document text

Page 1 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966486
Page 2 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep/2/2020
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966487
Page 3 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10881139]
2.Birth Date: /1938
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:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966488
Page 4 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966489
Page 5 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966490
Page 6 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966491
Page 7 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:[Chronic obstructive pulmonary disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[constipation]
Start Date: Jun/UNK/2020
Ongoing: YES
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966492
Page 8 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vitamin D deficiency]
Start Date: UNK/UNK/2017
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign prostatic hyperplasia (BPH)]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease (CAD)]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966493
Page 9 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [104.6]
3.Unit: kg
4.Height: [189.0]
5.Unit: cm
6.Body Mass Index: [29.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966494
Page 10 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249688]
3.Randomization Group: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966495
Page 11 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
Sep/2/2020
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 [BP9715]
5.bSample ID [BP9716]
5.cSample ID [BP9717]
5.dSample ID [BL9SW4]
5.eSample ID [BL9SW5]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966496
Page 12 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
Sep/2/2020
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 [BP97CN]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966497
Page 13 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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: Sep/2/2020 16:10
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
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966498
Page 14 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966499
Page 15 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966500
Page 16 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966501
Page 17 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[received pneumonia vaccine, delayed 28 days]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2S5J]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966502
Page 18 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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?YES
Date of First Delay:
Sep/21/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 14:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966503
Page 19 of 352
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966504
Page 20 of 352
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
Nov/11/2020
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 [BRFFWL]
5.bSample ID [BRFFWM]
5.cSample ID [BRFFWN]
5.dSample ID [BRZFBL]
5.eSample ID [BRZFBM]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966505
Page 21 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966506
Page 22 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966507
Page 23 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966508
Page 24 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966509
Page 25 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966510
Page 26 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966511
Page 27 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966512
Page 28 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/4/2021
2.Date of First Symptom Started: Jan/20/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966513
Page 29 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.aSymptoms - Other Text: [CHEST CONGESTION]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966514
Page 30 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Feb/3/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966515
Page 31 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/3/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966516
Page 32 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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_SELF
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV22406]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966517
Page 33 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966518
Page 34 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966519
Page 35 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966520
Page 36 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966521
Page 37 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[chest congestion]
Date of Diagnosis:
Feb/3/2021
3.Toxicity Grade: 2
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966522
Page 38 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966523
Page 39 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966524
Page 40 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966525
Page 41 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966526
Page 42 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966527
Page 43 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966528
Page 44 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966529
Page 45 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966530
Page 46 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966531
Page 47 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966532
Page 48 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966533
Page 49 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966534
Page 50 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966535
Page 51 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966536
Page 52 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966537
Page 53 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966538
Page 54 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966539
Page 55 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966540
Page 56 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966541
Page 57 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966542
Page 58 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966543
Page 59 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966544
Page 60 of 352
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966545
Page 61 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966546
Page 62 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966547
Page 63 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966548
Page 64 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966549
Page 65 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966550
Page 66 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966551
Page 67 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 :Mar/6/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966552
Page 68 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966553
Page 69 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966554
Page 70 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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  Metastases to the lun
gs Feb/24/2021 UNK
:UNK NO
End Date Time:
Mar/6/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Metastatic pancreatic
cancer Feb/24/2021 UNK
:UNK NO
End Date Time:
Mar/6/2021 UNK:UNK
 Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966555
Page 71 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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)[Metastases to the lungs]
4.Start Date Time: Feb/24/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/6/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966556
Page 72 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:
[Metastatic pancreatic cancer in the lungs]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2021253634]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966557
Page 73 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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)[Metastatic pancreatic cancer]
4.Start Date Time: Feb/24/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/6/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966558
Page 74 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:
[Metastatic pancreatic cancer in the lungs]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021253634]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966559
Page 75 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966560
Page 76 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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[ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966561
Page 77 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicati
onStart Da
teForm Instanc
e
 1.1  VACCINATIONS
 NO  PNEUMONIA VA
CCINE Sep/16/2
020 Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966562
Page 78 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[PNEUMONIA VACCINE]
5.Date: Sep/16/2020
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966563
Page 79 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966564
Page 80 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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?
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966565
Page 81 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966566
Page 82 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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?
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966567
Page 83 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966568
Page 84 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966569
Page 85 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966570
Page 86 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966571
Page 87 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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?
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966572
Page 88 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966573
Page 89 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966574
Page 90 of 352
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966575
Page 91 of 352
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966576
Page 92 of 352
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966577
Page 93 of 352
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966578
Page 94 of 352
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966579
Page 95 of 352
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966580
Page 96 of 352
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/7/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966581
Page 97 of 352
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966582
Page 98 of 352
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Mar/6/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Lung Cancer]
2.bCause of Death Status:
Cause of Death: [ ]
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966583
Page 99 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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 Mar/6/2021
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966584
Page 100 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0966585
Page 101 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
  Approved Mar-12-2021 10:13:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966586
Page 102 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-02-2020 20:53:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966587
Page 103 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966588
Page 104 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966589
Page 105 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966590
Page 106 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966591
Page 107 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966592
Page 108 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966593
Page 109 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-13-2021 15:16:34 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0966594
Page 110 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-13-2021 15:17:24 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966595
Page 111 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-13-2021 15:17:24 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966596
Page 112 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-13-2021 15:17:24 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966597
Page 113 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-13-2021 15:17:24 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966598
Page 114 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-13-2021 15:17:24 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966599
Page 115 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966600
Page 116 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966601
Page 117 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966602
Page 118 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
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ItemDate User Comment
4Feb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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(b) (4), (b) (6)
(b) (4)
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.aFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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(b) (4), (b) (6)
(b) (4)
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.aFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966614
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966615
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966616
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966617
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966618
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966619
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966620
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966621
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966622
Page 138 of 352
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966623
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966624
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966625
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966626
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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FDA-CBER-2021-5683-0966628
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Page 146 of 352
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gFeb-13-2021 15:17:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0966632
Page 148 of 352
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
2Feb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
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Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
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Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
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Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.aFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.bFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.bFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.bFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.bFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.cFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.cFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.cFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.cFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.dFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.dFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.dFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.dFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.eFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.eFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
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ItemDate User Comment
5.eFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.eFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5 fFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5 fFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5 fFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5 fFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.gFeb-13-2021 15:17:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.gFeb-13-2021 15:17:59 (UTC-05:00) Eastern
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Subject No: 10881139 Subject Initials: ---
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Subject No: 10881139 Subject Initials: ---
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Subject No: 10881139 Subject Initials: ---
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-13-2021 15:19:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966694
Page 210 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-13-2021 15:19:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966695
Page 211 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Feb-13-2021 15:19:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966696
Page 212 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-13-2021 15:19:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966697
Page 213 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-13-2021 15:19:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966698
Page 214 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-13-2021 15:19:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966699
Page 215 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-13-2021 15:19:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966700
Page 216 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-13-2021 15:19:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966701
Page 217 of 352
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/04/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-13-2021 15:19:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0966702
Page 218 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
  Approved Mar-12-2021 10:13:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Mar-10-2021 18:15:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Mar-10-2021 13:11:23 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Mar-09-2021 15:37:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966703
Page 219 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
  Approved Mar-09-2021 09:05:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Mar-08-2021 18:40:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Feb-23-2021 17:01:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Feb-22-2021 17:30:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Feb-22-2021 14:58:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966704
Page 220 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I,  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 Feb-19-2021 10:52:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Feb-15-2021 11:21:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Feb-13-2021 15:12:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Jan-12-2021 14:43:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966705
Page 221 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
 N/A Jan-08-2021 13:45:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Dec-14-2020 11:53:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 Dec-11-2020 14:17:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
  Approved Nov-12-2020 09:48:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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 13:58:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966706
Page 222 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
  Approved Nov-06-2020 16:20:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0966707
Page 223 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep-02-2020 20:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-02-2020 20:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966708
Page 224 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020 20:52:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/2/2020Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966709
Page 225 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020 20:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10881139Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020 20:52:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1938Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020 20:52:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020 20:52:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020 20:52:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966710
Page 226 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 20:53:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966711
Page 227 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep-02-2020 20:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020 20:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020 20:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966712
Page 228 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020 20:59:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Chronic obstructive
pulmonary disease
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020 20:59:25
(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-02-2020 20:59:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic obstructive pulmonary dis
easeInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020 20:59:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020 20:59:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966713
Page 229 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-02-2020 20:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:sleep apnea
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020 20:59:53
(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-02-2020 20:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
sleep apneaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020 20:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020 20:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-02-2020 21:00:22
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe 3Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966714
Page 230 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) r:
Medical History
Term:hypercholestero
lemia
Start Date: UNK/UNK/201
2
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 21:00:22
(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-02-2020 21:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 21:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 21:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-02-2020 21:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:constipationInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966715
Page 231 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Start Date: Jun/UNK/20
20
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020 21:00:57
(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-02-2020 21:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
constipationInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020 21:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020 21:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-02-2020 21:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:vitamin D defic
iency
Start Date: UNK/UNK/201
7Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966716
Page 232 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-02-2020 21:01:31
(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-02-2020 21:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
vitamin D deficiencyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-02-2020 21:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-02-2020 21:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-02-2020 21:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Benign prostatic hy
perplasia (BPH)
Start Date: UNK/UNK/2012
Ongoing: YESInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966717
Page 233 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Line/MH Number:
Date Location User Value Reason
Sep-02-2020 21:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 21:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Benign prostatic hyperplasia (BPH
)Initial Entry
1.f Start Date:
Date Location User Value Reason
Sep-02-2020 21:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-02-2020 21:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-02-2020 21:03:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Coronary Artery D
isease (CAD)
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966718
Page 234 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.g Line/MH Number:
Date Location User Value Reason
Sep-02-2020 21:03:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 21:03:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery Disease (CAD)Initial Entry
1.g Start Date:
Date Location User Value Reason
Sep-02-2020 21:03:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-02-2020 21:03:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966719
Page 235 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
104.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
189.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.3Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966720
Page 236 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 20:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966721
Page 237 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020 20:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020 20:55:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
249688Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966722
Page 238 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 20:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 20:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 20:56:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 20:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 20:55:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 20:56:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9715Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966723
Page 239 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 20:56:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9715Initial Entry
5.b
Date Location User Value Reason
Sep-02-2020 20:56:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9716Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 20:56:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9716Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020 20:56:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9717Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 20:56:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9717Initial Entry
5.d
Date Location User Value Reason
Sep-02-2020 20:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9SW4Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966724
Page 240 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 20:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9SW4Initial Entry
5.e
Date Location User Value Reason
Sep-02-2020 20:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9SW5Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 20:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9SW5Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966725
Page 241 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 20:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 20:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 20:57:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 20:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 20:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 07:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP97CNChanged
Information
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966726
Page 242 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020 20:57:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP97CMInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 07:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP97CNChanged
Information
Sep-02-2020 20:57:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP97CMInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966727
Page 243 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 16:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966728
Page 244 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-02-2020 20:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966729
Page 245 of 352
***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: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep-02-2020 20:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966730
Page 246 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 22:20:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966731
Page 247 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 12:09:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 12:09:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Changed
Information
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit.
Please review and
update as
appropriate or
clarify.
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966732
Page 248 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 22:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966733
Page 249 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 22:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 22:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-17-2020 02:41:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-16-2020 12:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered DELAY OF
VACCINATION
Oct-16-2020 12:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Deleted Close Auto Query
Oct-16-2020 12:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-16-2020 12:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Date of Collection
15/Oct/2020 is
greater than Date of
Visit 21/Sep/2020.
Please review and
update as
appropriate, else
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966734
Page 250 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
clarify.
Oct-16-2020 12:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020New Information
Sep-21-2020 22:22:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-21-2020 22:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update as
appropriate.
Sep-21-2020 22:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 22:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOUpdated
Sep-21-2020 22:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-21-2020 22:21:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (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-2021-5683-0966735
Page 251 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-21-2020 22:22:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
received pneumonia vaccine, delay
ed 28 daysInitial Entry
5.a
Date Location User Value Reason
Oct-16-2020 12:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2S5JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 12:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR2S5JInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966736
Page 252 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 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
Sep-22-2020 07:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 07:40:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/21/2020
Reason(s) for Temporary Delay
of Vaccination
RECENT NON-STUDY VAC
CINATIONNew Information
Sep-21-2020 22:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Was there a
temporary delay of
vaccination?' is
marked as Yes and
'Date of First Delay'
is not entered. Please
review and update as
appropriate.
Sep-21-2020 22:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Reason(s) for Temporary Delay
of Vaccination
RECENT NON-STUDY VAC
CINATIONInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0966737
Page 253 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 07:22:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-17-2020 13:13:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered delay dose date is
correct. unsure of
what the query is
asking.
Oct-17-2020 11:21:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rupali Dalavi Query 1: Reissued:Opened DM1:Per CRF
Completion
requirement section
8.25, for patients
with a temporary
delay of vaccination
at Visit 2, all the
forms should be
entered at the end of
the temporary delay
period, when the
vaccination is given.
Kindly verify date of
visit.
Oct-16-2020 12:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered delay of vaccination
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is not
equal to Date of
Visit 21/Sep/2020 of
the corresponding
Visit. Please review
and update as
appropriate.
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020 14:05Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (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) (4), 
(b) (6)
FDA-CBER-2021-5683-0966738
Page 254 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 12:08:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966739
Page 255 of 352
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 13:58:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966740
Page 256 of 352
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 13:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 13:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 13:59:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 13:59:03
(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.
Nov-11-2020 13:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 13:59:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFFWLInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966741
Page 257 of 352
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No: 10881139 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Nov-11-2020 13:59:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFFWLInitial Entry
5.b
Date Location User Value Reason
Nov-11-2020 13:59:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFFWMInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-11-2020 13:59:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFFWMInitial Entry
5.c
Date Location User Value Reason
Nov-11-2020 13:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFFWNInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-11-2020 13:59:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRFFWNInitial Entry
5.d
Date Location User Value Reason
Nov-11-2020 13:59:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRZFBLInitial Entry
090177e196ae3fa0\Final\Final On: 01-Apr-2021 05:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0966742
Page 258 of 352
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1088 Site Name: (1088) PMG Research of Hickory LLC
Subject No:
…[truncated]