125742 S1 M5 CRF c4591001 1027 10271191

Document text

Page 1 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901064
Page 2 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/11/2020
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901065
Page 3 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10271191]
2.Birth Date: /1952
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901066
Page 4 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901067
Page 5 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901068
Page 6 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901069
Page 7 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[emphysema]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2013
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901070
Page 8 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dysmenorrhea]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lung cancer]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Jan/UNK/2018
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thyroid cancer]
Start Date: UNK/UNK/1982
Ongoing: NO
End Date:
UNK/UNK/1982
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[thyroidectomy]
Start Date: UNK/UNK/1982
Ongoing: NO
End Date:
UNK/UNK/1982
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901071
Page 9 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[irritable bowel syndrome (IBS) - constipation]
Start Date: UNK/UNK/2014
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to cipro]
Start Date: UNK/UNK/1975
Ongoing: YES
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901072
Page 10 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
2.Weight: [137.4]
3.Unit: LB
4.Height: [66.5]
5.Unit: in
6.Body Mass Index: [21.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901073
Page 11 of 637
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901074
Page 12 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/11/2020
2.Randomization Number: [258126]
3.Randomization Group: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901075
Page 13 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP29M6]
5.bSample ID [BLBB4P]
5.cSample ID [BLC1JZ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901076
Page 14 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BN6145]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901077
Page 15 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/11/2020 12:59
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
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901078
Page 16 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901079
Page 17 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901080
Page 18 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901081
Page 19 of 637
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901082
Page 20 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BP297L]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901083
Page 21 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/2/2020 09:20
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
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901084
Page 22 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901085
Page 23 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BP29VX]
5.bSample ID [BLB9MP]
5.cSample ID [BLC1SM]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901086
Page 24 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901087
Page 25 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901088
Page 26 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901089
Page 27 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901090
Page 28 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901091
Page 29 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901092
Page 30 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901093
Page 31 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/17/2020
2.Date of First Symptom Started: Dec/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/23/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901094
Page 32 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [Head Congestion]
5.bSymptoms - Other Text: [Dizziness]
5.cSymptoms - Other Text: [Headache]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901095
Page 33 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901096
Page 34 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901097
Page 35 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Site staff collected Nasal Swab.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2993]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901098
Page 36 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2993]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901099
Page 37 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901100
Page 38 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901101
Page 39 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901102
Page 40 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment
IdentifierCon Non-Drug Treat
ments Pre-specifiedTreatment TreatmentStart
DateForm Instan
ce
 1. DELETED 1    HIGH FLOW OXY
GEN THERAPY HIGH FLOW OXY
GEN THERAPY   Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901103
Page 41 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY ]
5.Start Date: //
6.Ongoing? YES
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901104
Page 42 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901105
Page 43 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901106
Page 44 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901107
Page 45 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicab
le Not Appl
icable Not Appli
cable Not Appl
icable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  C Reactive Protein_
PX329 Not Appl
icable 
Not Applicable  Alanine Aminotrans
ferase_PX30 Not Appl
icable 
Not Applicable  Aspartate Aminotra
nsferase_PX28 Not Appl
icable 
Not Applicable  Alkaline Phosphatas
e_PX35 Not Appl
icable 
Not Applicable  Bilirubin_PX21  Not Appl
icable 
Not Applicable  Blood Urea Nitroge
n_PX47 Not Appl
icable 
Not Applicable  Creatinine_PX48  Not Appl
icable Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901108
Page 46 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 2.CLINICAL C
HEMISTRY Wesley Long Com
munity Hospital
2400 W. Friendly
Avenue
Greensboro, NC 2
7403 Jan/19/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 2.7 
30  Alanine Aminotra
nsferase_PX30 13 
28  Aspartate Aminotr
ansferase_PX28 29 
35  Alkaline Phosphat
ase_PX35 85 
21  Bilirubin_PX21  0.5 
47  Blood Urea Nitrog
en_PX47 19 
48  Creatinine_PX48  0.77
 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901109
Page 47 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901110
Page 48 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901111
Page 49 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901112
Page 50 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901113
Page 51 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Wesley Long Community Hospital
2400 W. Friendly Avenue
Greensboro, NC 27403]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [2.7]
Not Done:
LNMT Low
[ ]
High
[<1.0]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [13]
Not Done:
LNMT Low
[0]
High
[44]
Unit
U/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901114
Page 52 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [29]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [85]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901115
Page 53 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[8]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.77]
Not Done:
LNMT Low
[0.44]
High
[1.00]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901116
Page 54 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901117
Page 55 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category fo
r Lab TestVendor Name (D
ERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
 2. DELETED HEMATOL
OGY Wesley Long Co
mmunity Hospita
l
2400 W. Friendly
Avenue
Greensboro, NC
27403 Jan/19/2
021 BLOOD
 Sponsor-Defi
ned IdentifierTest:Res
ult:
1  Hemoglobi
n_PX1 11.5
 
2  Hematocrit
_PX2 35.9
 
3  Erythrocyte
s_PX3 [ ] 
5  Platelets_P
X5 234 
7  Leukocytes
_PX7 [ ] 
608  Neutrophils
_PX608 8.8 
609  Eosinophils
_PX609 0.0 
612  Monocytes
_PX612 0.7 
610  Basophils_
PX610 0.0 
611  Lymphocyt
es_PX611 0.5 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901118
Page 56 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901119
Page 57 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901120
Page 58 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901121
Page 59 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901122
Page 60 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901123
Page 61 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901124
Page 62 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Wesley Long Community Hospital
2400 W. Friendly Avenue
Greensboro, NC 27403 ]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.5]
Not Done:
LNMT Low
[12.0]
High
[15.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [35.9]
Not Done:
LNMT Low
[36.0]
High
[46.0]
Unit
%
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901125
Page 63 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [234]
Not Done:
LNMT Low
[150]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901126
Page 64 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [8.8]
Not Done:
LNMT Low
[1.7]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.7]
Not Done:
LNMT Low
[1.0]
High
[1.0]
Unit
/uL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901127
Page 65 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.1]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.5]
Not Done:
LNMT Low
[0.7]
High
[4.0]
Unit
/uL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901128
Page 66 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901129
Page 67 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 2. DELETED  Record Identifier: Systolic: Diastolic:
1  114  82 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901130
Page 68 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901131
Page 69 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: //
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [114]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [81]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901132
Page 70 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
1  Not Applicable Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901133
Page 71 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 2. DELETED Jan/18/2021 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901134
Page 72 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901135
Page 73 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/18/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901136
Page 74 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901137
Page 75 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901138
Page 76 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901139
Page 77 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901140
Page 78 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assess
mentLocation of Assess
mentImaging Met
hodOverall Assessment Form Instance
 1. DELETED Jan/18/2021  CHEST  CT SCAN  ABNORMAL
If abnormal, specify findings:
Multifocal Pneumonia, Emph
ysema
 Repeating
Pages
 2. DELETED   CHEST  X-RAY  NORMAL  Repeating
Pages
 3. DELETED   HEAD  CT SCAN  NORMAL  Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901141
Page 79 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/18/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Multifocal Pneumonia, Emphysema ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901142
Page 80 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: //
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901143
Page 81 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: //
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901144
Page 82 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901145
Page 83 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/13/2021
2.Date of First Symptom Started: Jan/12/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/13/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901146
Page 84 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [Syncope]
5.bSymptoms - Other Text: [Pain under Right Breast]
5.cSymptoms - Other Text: [Headache]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901147
Page 85 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/14/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901148
Page 86 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/14/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT-Unknown] Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901149
Page 87 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [CV49510]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901150
Page 88 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject collected self swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901151
Page 89 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901152
Page 90 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/18/2021  YES  Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901153
Page 91 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/18/2021
4.Ongoing? YES
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901154
Page 92 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Id
entifierCon Non-Drug Treatmen
ts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Jan/18/2
021 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901155
Page 93 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Jan/18/2021
6.Ongoing? YES
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901156
Page 94 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[COVID-19]
Date of Diagnosis:
Jan/14/2021
3.Toxicity Grade: 5
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901157
Page 95 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901158
Page 96 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901159
Page 97 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Tes
tVendor NameCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICAL
CHEMIST
RY Wesley Long Community Hospit
al,2400 W. Friendly Ave Greensb
oro, NC 27403 Jan/20/
2021 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
329  C Reactive Pro
tein_PX329 1.2 
30  Alanine Amin
otransferase_P
X30 12 
28  Aspartate Ami
notransferase_
PX28 30 
35  Alkaline Phos
phatase_PX35 82 
21  Bilirubin_PX2
1 0.6 
47  Blood Urea Ni
trogen_PX47 25 
48  Creatinine_PX
48 0.6
7 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901160
Page 98 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
 2. CLINICA
L CHEMI
STRY Wesley Long Community H
ospital,2400 W. Friendly Av
e Greensboro, NC 27403 Jan/19
/2021 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 2.7
 
30  Alanine Ami
notransferas
e_PX30 13 
28  Aspartate A
minotransfer
ase_PX28 29 
35  Alkaline Pho
sphatase_PX
35 85 
21  Bilirubin_P
X21 0.5
 
47  Blood Urea
Nitrogen_P
X47 19 
48  Creatinine_P
X48 0.7
7 Repeating
Pages
 3. DELETED CLINICA
L CHEMI
STRY Wesley Long Community H
ospital,2400 W. Friendly Av
e Greensboro, NC 27403 Jan/19
/2021 BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329  C Reactive P
rotein_PX32
9 2.7
 
30  Alanine Ami
notransferas
e_PX30 13 
28  Aspartate A
minotransfer
ase_PX28 29 
35  Alkaline Pho
sphatase_PX85 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901161
Page 99 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
35 
21  Bilirubin_P
X21 0.5
 
47  Blood Urea
Nitrogen_P
X47 19 
48  Creatinine_P
X48 0.7
7 
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901162
Page 100 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Wesley Long Community Hospital,2400 W. Friendly Ave Greensboro, NC
27403]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.2]
Not Done:
LNMT Low
[UNK]
High
[UNK]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [12]
Not Done:
LNMT Low
[0]
High
[44]
Unit
U/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901163
Page 101 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [30]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [82]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901164
Page 102 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [25]
Not Done:
LNMT Low
[8]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.67]
Not Done:
LNMT Low
[0.44]
High
[1.00]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901165
Page 103 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Wesley Long Community Hospital,2400 W. Friendly Ave Greensboro, NC
27403]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [2.7]
Not Done:
LNMT Low
[ ]
High
[<1.0]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [13]
Not Done:
LNMT Low
[0]
High
[44]
Unit
U/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901166
Page 104 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [29]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [85]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901167
Page 105 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[8]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.77]
Not Done:
LNMT Low
[0.44]
High
[1.00]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901168
Page 106 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Deleted, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Wesley Long Community Hospital,2400 W. Friendly Ave Greensboro, NC
27403]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [2.7]
Not Done:
LNMT Low
[ ]
High
[<1.0]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [13]
Not Done:
LNMT Low
[0]
High
[44]
Unit
U/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901169
Page 107 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Deleted, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [29]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [85]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901170
Page 108 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Deleted, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [19]
Not Done:
LNMT Low
[8]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.77]
Not Done:
LNMT Low
[0.44]
High
[1.00]
Unit
mg/dL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901171
Page 109 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Te
stVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Wesley Long Community Hospital,
2400 W. Friendly Ave. Greensboro,
NC 27403 Jan/20/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1  Hemoglob
in_PX1 11.
1 
2  Hematocri
t_PX2 34.
2 
3  Erythrocy
tes_PX3 4.2
7 
5  Platelets_
PX5 282
 
7  Leukocyte
s_PX7 10.
6 
608  Neutrophi
ls_PX608 9.1 
609  Eosinophi
ls_PX609 0.0 
612  Monocyte
s_PX612 0.7 
610  Basophils
_PX610 0.0 
611  Lymphoc
ytes_PX6
11 0.7 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901172
Page 110 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Te
stVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 2.HEMATO
LOGY Wesley Long Community Hospital,
2400 W. Friendly Ave. Greensboro,
NC 27403 Jan/19/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1  Hemoglob
in_PX1 11.
5 
2  Hematocri
t_PX2 35.
9 
3  Erythrocy
tes_PX3 [ ] 
5  Platelets_
PX5 234
 
7  Leukocyte
s_PX7 [ ] 
608  Neutrophi
ls_PX608 8.8 
609  Eosinophi
ls_PX609 0.0 
612  Monocyte
s_PX612 0.7 
610  Basophils
_PX610 0.0 
611  Lymphoc
ytes_PX6
11 0.5 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901173
Page 111 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Wesley Long Community Hospital, 2400 W. Friendly Ave. Greensboro, NC
27403]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.1]
Not Done:
LNMT Low
[12.0]
High
[15.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [34.2]
Not Done:
LNMT Low
[36.0]
High
[46.0]
Unit
%
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901174
Page 112 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.27]
Not Done:
LNMT Low
[3.87]
High
[5.11]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [282]
Not Done:
LNMT Low
[150]
High
[400]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [10.6]
Not Done:
LNMT Low
[4.0]
High
[10.5]
Unit
10^9/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901175
Page 113 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [9.1]
Not Done:
LNMT Low
[1.7]
High
[7.7]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.7]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
10^9/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901176
Page 114 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.1]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.7]
Not Done:
LNMT Low
[0.7]
High
[4.0]
Unit
10^9/L
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901177
Page 115 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Wesley Long Community Hospital, 2400 W. Friendly Ave. Greensboro, NC
27403]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.5]
Not Done:
LNMT Low
[12.0]
High
[15.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [35.9]
Not Done:
LNMT Low
[36.0]
High
[46.0]
Unit
%
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901178
Page 116 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [234]
Not Done:
LNMT Low
[150]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901179
Page 117 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [8.8]
Not Done:
LNMT Low
[1.7]
High
[7.7]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.7]
Not Done:
LNMT Low
[1.0]
High
[1.0]
Unit
/uL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901180
Page 118 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.5]
Not Done:
LNMT Low
[0.7]
High
[4.0]
Unit
/uL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901181
Page 119 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/18/2021 Record Identifier: Systolic: Diastolic:
1  114  82 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901182
Page 120 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/18/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [114]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [81]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901183
Page 121 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/18/2021 Record Identifier: Oxygen Saturation
1  80.0 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901184
Page 122 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 20-Feb-2021 02:11
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 2. DELETED Jan/18/2021 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901185
Page 123 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/18/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [80.0]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901186
Page 124 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete, Deleted, Frozen
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/18/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0] Comments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901187
Page 125 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901188
Page 126 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901189
Page 127 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901190
Page 128 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901191
Page 129 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of
Assessm
entLocation
of Assess
mentImagin
g Meth
odOverall AssessmentForm Insta
nce
 1.Jan/20/2
021 CHEST  CT SC
AN ABNORMAL
If abnormal, specify findings:
No CT evidence of large or central pulmonary artery embolus.Multi
focal Pneumonia.Left Upper Lobe and right hilar/suprahilar postradi
ation changes noted.Emphysema
 Repeating
Pages
 2.Jan/18/2
021 CHEST  X-RAY  NORMAL  Repeating
Pages
 3.Jan/18/2
021 HEAD  CT SC
AN NORMAL  Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901192
Page 130 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[No CT evidence of large or central pulmonary artery embolus.Multifocal
Pneumonia.Left Upper Lobe and right hilar/suprahilar postradiation changes
noted.Emphysema]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901193
Page 131 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/18/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901194
Page 132 of 637
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/13/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/18/2021
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901195
Page 133 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901196
Page 134 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901197
Page 135 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901198
Page 136 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901199
Page 137 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901200
Page 138 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Feb/13/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901201
Page 139 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901202
Page 140 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901203
Page 141 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Acute Hypoxic Respirato
ry Failure Jan/12/2021 UN
K:UNK NO
End Date Time:
Feb/13/2021 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  COVID-19  Jan/12/2021 UN
K:UNK NO
End Date Time:
Feb/13/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901204
Page 142 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Acute Hypoxic Respiratory Failure]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/13/2021 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
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901205
Page 143 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Diagnosis of COVID-19]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2021058513]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901206
Page 144 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[COVID-19]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/13/2021 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
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901207
Page 145 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Viral Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2021058513]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901208
Page 146 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901209
Page 147 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901210
Page 148 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901211
Page 149 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901212
Page 150 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901213
Page 151 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901214
Page 152 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901215
Page 153 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901216
Page 154 of 637
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901217
Page 155 of 637
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901218
Page 156 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901219
Page 157 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901220
Page 158 of 637
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901221
Page 159 of 637
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901222
Page 160 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901223
Page 161 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901224
Page 162 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901225
Page 163 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901226
Page 164 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901227
Page 165 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901228
Page 166 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901229
Page 167 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901230
Page 168 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901231
Page 169 of 637
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901232
Page 170 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Feb/13/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Acute Hypoxic Respiratory Failure.]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [COVID-19]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901233
Page 171 of 637
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901234
Page 172 of 637
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901235
Page 173 of 637
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901236
Page 174 of 637
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901237
Page 175 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/13/2021
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901238
Page 176 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901239
Page 177 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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-05-2021 08:57:22 (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.
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901240
Page 178 of 637
***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: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-11-2020 14:26:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901241
Page 179 of 637
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-11-2020 14:33:26 (UTC-05:00) Eastern
Time (US & Canada)hysterectomy - 1990
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901242
Page 180 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 11:09:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901243
Page 181 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901244
Page 182 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901245
Page 183 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901246
Page 184 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901247
Page 185 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901248
Page 186 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901249
Page 187 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901250
Page 188 of 637
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-02-2020 11:09:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901251
Page 189 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901252
Page 190 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901253
Page 191 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901254
Page 192 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901255
Page 193 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901256
Page 194 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901257
Page 195 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901258
Page 196 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901259
Page 197 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901260
Page 198 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Dec-17-2020 10:13:11 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901261
Page 199 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-02-2021 12:47:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901262
Page 200 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-02-2021 12:47:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901263
Page 201 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-02-2021 12:47:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901264
Page 202 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-02-2021 12:47:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901265
Page 203 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-02-2021 12:47:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901266
Page 204 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:25:02 (UTC-05:00) Eastern
Time (US & Canada)Confirmed
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901267
Page 205 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-08-2021 10:21:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901268
Page 206 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-08-2021 10:21:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901269
Page 207 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-08-2021 10:21:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
2Feb-08-2021 10:21:26 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901270
Page 208 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-08-2021 10:21:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901271
Page 209 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-08-2021 10:21:42 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901272
Page 210 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
FormFeb-08-2021 09:57:37 (UTC-05:00) Eastern
Time (US & Canada)Done
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901273
Page 211 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901274
Page 212 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901275
Page 213 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901276
Page 214 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901277
Page 215 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901278
Page 216 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901279
Page 217 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901280
Page 218 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901281
Page 219 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901282
Page 220 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901283
Page 221 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901284
Page 222 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901285
Page 223 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901286
Page 224 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901287
Page 225 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901288
Page 226 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901289
Page 227 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901290
Page 228 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901291
Page 229 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901292
Page 230 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901293
Page 231 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901294
Page 232 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901295
Page 233 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901296
Page 234 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901297
Page 235 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901298
Page 236 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901299
Page 237 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901300
Page 238 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901301
Page 239 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901302
Page 240 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901303
Page 241 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901304
Page 242 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:02 (UTC-05:00) Eastern
Time (US & Canada)Done
Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901305
Page 243 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901306
Page 244 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901307
Page 245 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901308
Page 246 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901309
Page 247 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901310
Page 248 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901311
Page 249 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901312
Page 250 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901313
Page 251 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901314
Page 252 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901315
Page 253 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901316
Page 254 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901317
Page 255 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901318
Page 256 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901319
Page 257 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901320
Page 258 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901321
Page 259 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.dFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901323
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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, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901324
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901325
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901326
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901327
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901328
Page 266 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901329
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901330
Page 268 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901331
Page 269 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901332
Page 270 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901333
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901334
Page 272 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901335
Page 273 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901336
Page 274 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901337
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901338
Page 276 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901339
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901340
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901341
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901342
Page 280 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901343
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901344
Page 282 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901345
Page 283 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901346
Page 284 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901347
Page 285 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901348
Page 286 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901349
Page 287 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 14:22:46 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901350
Page 288 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
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Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901351
Page 289 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901352
Page 290 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901353
Page 291 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
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Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901354
Page 292 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901355
Page 293 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 14:23:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901356
Page 294 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 14:24:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901357
Page 295 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 14:24:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
1Feb-09-2021 14:23:32 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901358
Page 296 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1027 Site Name: (1027) PharmQuest
Subject No: 10271191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 14:24:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
2.aFeb-09-2021 14:24:06 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e14\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901359
Page 297 of 637
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit

…[truncated]