Document text
Page 1 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936193
Page 2 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936194
Page 3 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311151]
2.Birth Date: /1937
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936195
Page 4 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936196
Page 5 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936197
Page 6 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936198
Page 7 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hearing loss in both ears]
Start Date: UNK/UNK/1970
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hearing device wearer in both ears]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[myopia]
Start Date: UNK/UNK/1953
Ongoing: YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936199
Page 8 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[glaucoma]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[cataract surgery in both eyes]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[chronic dry eye]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936200
Page 9 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[allergic rhinitis, seasonal]
Start Date: UNK/UNK/1970
Ongoing: YES
1.hLine/MH Number: [8] Comments
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[moderate intermittent asthma] Comments
Start Date: UNK/UNK/1985 Comments
Ongoing: YES Comments
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[heart attack]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936201
Page 10 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[high blood pressure]
Start Date: UNK/UNK/1990
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[edema in both feet]
Start Date: UNK/UNK/2016
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[mixed hyperlipdemia]
Start Date: UNK/UNK/1990
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[atherosclerosis in both carotid arteries]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936202
Page 11 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[recurrent heartburn]
Start Date: UNK/UNK/2018
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[chronic kidney disease, stage 3]
Start Date: UNK/UNK/2010
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[urinary incontinence]
Start Date: UNK/UNK/2011
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[erectile dysfunction]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936203
Page 12 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[benign prostatic hypertrophy with urinary obstruction]
Start Date: UNK/UNK/2010
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[transient ischemic attacks, more than one per subject, but not
clear on specific number]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[chronic anemia]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936204
Page 13 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis in both hands]
Start Date: Mar/UNK/2020
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[prostate cancer]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.wLine/MH Number: [23]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[tobacco use, past, cigarettes, 0.5 pack per day]
Start Date: UNK/UNK/1958
Ongoing: NO
End Date:
UNK/UNK/1964
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936205
Page 14 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.xLine/MH Number: [24]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[deviated septum repair]
Start Date: UNK/UNK/1970
Ongoing: NO
End Date:
UNK/UNK/1970
1.yLine/MH Number: [25]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[prostatectomy]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936206
Page 15 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [78.0]
3.Unit: kg
4.Height: [161.4]
5.Unit: cm
6.Body Mass Index: [29.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936207
Page 16 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [255113]
3.Randomization Group: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936208
Page 17 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BN6DSB]
5.bSample ID [BL9W0M]
5.cSample ID [BL9W0N]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936209
Page 18 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BN6DZJ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936210
Page 19 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/8/2020 21:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936211
Page 20 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936212
Page 21 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936213
Page 22 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936214
Page 23 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9B2P]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936215
Page 24 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 13:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936216
Page 25 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936217
Page 26 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [BS7XBY]
5.bSample ID [BS7XBX]
5.cSample ID [BP99ZF]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936218
Page 27 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936219
Page 28 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936220
Page 29 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936221
Page 30 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936222
Page 31 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936223
Page 32 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936224
Page 33 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936225
Page 34 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/16/2020
2.Date of First Symptom
Started:Dec/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/19/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936226
Page 35 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]
5.bSymptoms - Other Text: [nasal drainage]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936227
Page 36 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
1.Not Ap
plicable
Not Appli
cable Not Applica
ble Not Applicable Not Applicabl
e Repeating
Pages
2.Jan/17/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936228
Page 37 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936229
Page 38 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/17/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [nalt unknown]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936230
Page 39 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:[waiting on swab from subject]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936231
Page 40 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936232
Page 41 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936233
Page 42 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936234
Page 43 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Hospitalization Catego
ryHospitalization
TermAdmission
DateOngoing Form Instance
1.HOSPITALIZATION ST
ATUS HOSPITAL Dec/17/2020 NO
Discharge D
ate:
Dec/19/202
0
Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936235
Page 44 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/17/2020
4.Ongoing? NO
Discharge Date:
Dec/19/2020
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936236
Page 45 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936237
Page 46 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936238
Page 47 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: 1
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936239
Page 48 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936240
Page 49 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936241
Page 50 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendor
NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.Not Applic
able Not Ap
plicable
Not App
licable Not Ap
plicable
Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936242
Page 51 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendo
r Nam
eCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
2.CLINICAL
CHEMIST
RY [ ] Dec/17/
2020 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
329 C Reactive Pro
tein_PX329 [ ]
30 Alanine Amin
otransferase_P
X30 [ ]
28 Aspartate Ami
notransferase_
PX28 [ ]
35 Alkaline Phos
phatase_PX35 [ ]
21 Bilirubin_PX2
1 [ ]
47 Blood Urea Ni
trogen_PX47 43
48 Creatinine_PX
48 2.0 Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936243
Page 52 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendo
r Nam
eCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
3.CLINICAL
CHEMIST
RY [ ] Dec/18/
2020 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
329 C Reactive Pro
tein_PX329 [ ]
30 Alanine Amin
otransferase_P
X30 [ ]
28 Aspartate Ami
notransferase_
PX28 [ ]
35 Alkaline Phos
phatase_PX35 [ ]
21 Bilirubin_PX2
1 [ ]
47 Blood Urea Ni
trogen_PX47 40
48 Creatinine_PX
48 1.7 Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936244
Page 53 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936245
Page 54 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936246
Page 55 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936247
Page 56 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936248
Page 57 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936249
Page 58 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936250
Page 59 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936251
Page 60 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[ ]
3.Collection Date: Dec/17/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936252
Page 61 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936253
Page 62 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936254
Page 63 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [43]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/L
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [2.0]
Not Done:
LNMT Low
[0.7]
High
[1.3]
Unit
mg/dL
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936255
Page 64 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and
Address[ ]
3.Collection Date: Dec/18/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936256
Page 65 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936257
Page 66 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936258
Page 67 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [40]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.7]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936259
Page 68 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
1.Not Appli
cable Not Applica
ble Not Ap
plicable
Not Ap
plicabl
e Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936260
Page 69 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936261
Page 70 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
2.HEMATO
LOGY [ ] Dec/17/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglo
bin_PX1 12.
5
2 Hematocr
it_PX2 36.
9
3 Erythrocy
tes_PX3 [ ]
5 Platelets_
PX5 129
7 Leukocyt
es_PX7 6.4
608 Neutrophi
ls_PX608
68.
2
609 Eosinophi
ls_PX609
[ ]
612 Monocyte
s_PX612 [ ]
610 Basophils
_PX610 [ ]
611 Lymphoc
ytes_PX6[ ] Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936262
Page 71 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Res
ult:
11
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936263
Page 72 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
3.HEMATO
LOGY [ ] Dec/18/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglo
bin_PX1 11.
1
2 Hematocr
it_PX2 32.
6
3 Erythrocy
tes_PX3 [ ]
5 Platelets_
PX5 108
7 Leukocyt
es_PX7 [ ]
608 Neutrophi
ls_PX608
[ ]
609 Eosinophi
ls_PX609
[ ]
612 Monocyte
s_PX612 [ ]
610 Basophils
_PX610 [ ]
611 Lymphoc
ytes_PX6[ ] Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936264
Page 73 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Res
ult:
11
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936265
Page 74 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936266
Page 75 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936267
Page 76 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936268
Page 77 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936269
Page 78 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936270
Page 79 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936271
Page 80 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936272
Page 81 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936273
Page 82 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936274
Page 83 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936275
Page 84 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[ ]
3.Collection Date: Dec/17/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.5]
Not Done:
LNMT Low
[13.1]
High
[17.6]
Unit
/uL
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936276
Page 85 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.9]
Not Done:
LNMT Low
[39]
High
[51.5]
Unit
%
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936277
Page 86 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [129]
Not Done:
LNMT Low
[154]
High
[393]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.4]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936278
Page 87 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [68.2]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936279
Page 88 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936280
Page 89 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936281
Page 90 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and
Address[ ]
3.Collection Date: Dec/18/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.1]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936282
Page 91 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [32.6]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936283
Page 92 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [108]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936284
Page 93 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936285
Page 94 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936286
Page 95 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936287
Page 96 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
1.Dec/17/2020 Record Identifier: Systolic: Diastolic:
Not Applicable 224 70 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936288
Page 97 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
2. DELETED Dec/18/2020 Record Identifier: Systolic: Diastolic:
1 136 58 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936289
Page 98 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 20-Feb-2021 02:11
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
3. Dec/18/2020 Record Identifier: Systolic: Diastolic:
1 180 66 Repeating Pages
4. Dec/19/2020 Record Identifier: Systolic: Diastolic:
1 168 71 Repeating Pages
5. DELETED Dec/17/2020 Record Identifier: Systolic: Diastolic:
1 186 53 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936290
Page 99 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/17/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [224] Comments
Diastolic: [70] Comments
Respiratory Rate in
respirations/minute:[18] Comments
Heart Rate in
beats/minute:[40] Comments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936291
Page 100 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [136]
Diastolic: [58]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in
beats/minute:[36]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936292
Page 101 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [180]
Diastolic: [66]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in
beats/minute:[35]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936293
Page 102 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [168]
Diastolic: [71]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in
beats/minute:[71]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936294
Page 103 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [186]
Diastolic: [53]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in
beats/minute:[40]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936295
Page 104 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
1.Dec/17/2020 Record Identifier: Oxygen Saturation
Not Applicable 99.0 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936296
Page 105 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
2.Dec/28/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936297
Page 106 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 20-Feb-2021 02:11
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
3. Dec/19/2020 Record Identifier: Oxygen Saturation
1 93.0 Repeating Pages
4. DELETED Record Identifier: Oxygen Saturation
1 Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936298
Page 107 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/17/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0] Comments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936299
Page 108 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936300
Page 109 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 20-Feb-2021 02:11 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/19/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936301
Page 110 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 20-Feb-2021 02:11 Form Status: Incomplete, Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** 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
SPO2 Pulse Oximetry % [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936302
Page 111 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936303
Page 112 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
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(b) (4)
FDA-CBER-2021-5683-0936304
Page 113 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not App
licable Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936305
Page 114 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
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(b) (4)
FDA-CBER-2021-5683-0936306
Page 115 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of
Assess
mentLocatio
n of Ass
essmentImagi
ng Me
thodOverall AssessmentForm Insta
nce
1.Dec/17/
2020 CHEST X-RA
Y ABNORMAL
If abnormal, specify findings:
Mild cardiomegaly. Mild vascular congestion
and interstitial edema is questioned. No focal l
ung consolidation, pleural fluid or pneumothor
ax.
Repeating
Pages
2.Dec/17/
2020 HEAD CT SC
AN ABNORMAL
If abnormal, specify findings:
No acute intracranial process.
Mild atrophy and chronic small vessel ischemi
c changes.
Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936307
Page 116 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/17/2020 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: X-RAY Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Mild cardiomegaly. Mild vascular congestion
and interstitial edema is questioned. No focal
lung consolidation, pleural fluid or
pneumothorax.]Comments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936308
Page 117 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/17/2020
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[No acute intracranial process.
Mild atrophy and chronic small vessel ischemic changes.]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936309
Page 118 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
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(b) (4)
FDA-CBER-2021-5683-0936310
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936311
Page 120 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection
Location:
4.Assay Code and
Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
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(b) (4)
FDA-CBER-2021-5683-0936312
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936313
Page 122 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936314
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936315
Page 124 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936316
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936317
Page 126 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0936318
Page 127 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936319
Page 128 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936320
Page 129 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0936321
Page 130 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
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(b) (4)
FDA-CBER-2021-5683-0936322
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***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936323
Page 132 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936324
Page 133 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936325
Page 134 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936326
Page 135 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936327
Page 136 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936328
Page 137 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936329
Page 138 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936330
Page 139 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936331
Page 140 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/26/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR0F9F]
5.bSample ID [BS7XW8]
5.cSample ID [BS7XW9]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936332
Page 141 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936333
Page 142 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936334
Page 143 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936335
Page 144 of 723
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936336
Page 145 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936337
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***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936338
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***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# CategoryAE Id
entifie
rAdverse E
ventStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
1. ADVER
SE EVE
NT 1 complete h
eart block Dec/8/2020
UNK:UNK
NO
End Date Time:
Dec/19/2020 U
NK:UNK
Repeating
Pages
2. ADVER
SE EVE
NT 2 hypokalemi
a Dec/17/202
0 UNK:UN
K NO
End Date Time:
Dec/18/2020 U
NK:UNK
Repeating
Pages
3. ADVER
SE EVE
NT 3 symptomati
c bradycard
ia Dec/8/2020
UNK:UNK
NO
End Date Time:
Dec/19/2020 U
NK:UNK
Repeating
Pages
4. DELETED Not Applic
able Dec/17/202
0 18:43 NO
End Date Time:
Dec/19/2020 U
NK:UNK
Repeating
Pages
5. ADVER
SE EVE
NT 5 hypertensiv
e urgency Dec/17/202
0 UNK:UN
K NO
End Date Time:
Dec/19/2020 URepeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936339
Page 148 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# CategoryAE Id
entifie
rAdverse E
ventStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
NK:UNK
6. ADVER
SE EVE
NT 6 mild cardio
megaly Dec/17/202
0 UNK:UN
K YES Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936340
Page 149 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[complete heart block]
4.Start Date Time: Dec/8/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936341
Page 150 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[A-V conduction block]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936342
Page 151 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020511089]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936343
Page 152 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[hypokalemia]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/18/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936344
Page 153 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936345
Page 154 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936346
Page 155 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[symptomatic bradycardia]
4.Start Date Time: Dec/8/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936347
Page 156 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[complete heart block]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936348
Page 157 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936349
Page 158 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)Not Applicable
[ ]Comments
4.Start Date Time: Dec/17/2020 18:43
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936350
Page 159 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital
anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
YES
Did this serious event result in persistent or
significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
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
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936351
Page 160 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[av conduction block ]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936352
Page 161 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[hypertensive urgency]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936353
Page 162 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Block]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936354
Page 163 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936355
Page 164 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[mild cardiomegaly]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936356
Page 165 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT NON-DRUG TREATMENT
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936357
Page 166 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936358
Page 167 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936359
Page 168 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936360
Page 169 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936361
Page 170 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936362
Page 171 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936363
Page 172 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936364
Page 173 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936365
Page 174 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936366
Page 175 of 723
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936367
Page 176 of 723
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936368
Page 177 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936369
Page 178 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936370
Page 179 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936371
Page 180 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936372
Page 181 of 723
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936373
Page 182 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936374
Page 183 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936375
Page 184 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936376
Page 185 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936377
Page 186 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936378
Page 187 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936379
Page 188 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936380
Page 189 of 723
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936381
Page 190 of 723
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936382
Page 191 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936383
Page 192 of 723
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936384
Page 193 of 723
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0936385
Page 194 of 723
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-08-2020 20:51:20 (UTC-05:00)
Eastern Time (US & Canada)no inclusion or exclusion criteria met
Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936386
Page 195 of 723
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.hSep-09-2020 10:35:47 (UTC-05:00)
Eastern Time (US & Canada)rarely needs albuterol inhaler and no
daily medication
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936387
Page 196 of 723
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.hSep-09-2020 10:35:47 (UTC-05:00)
Eastern Time (US & Canada)rarely needs albuterol inhaler and no
daily medication
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936388
Page 197 of 723
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.hSep-09-2020 10:35:47 (UTC-05:00)
Eastern Time (US & Canada)rarely needs albuterol inhaler and no
daily medication
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936389
Page 198 of 723
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1.hSep-09-2020 10:35:47 (UTC-05:00)
Eastern Time (US & Canada)rarely needs albuterol inhaler and no
daily medication
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936390
Page 199 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936391
Page 200 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936392
Page 201 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936393
Page 202 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936394
Page 203 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936395
Page 204 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-23-2020 12:15:56 (UTC-05:00)
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ItemDate User Comment
6Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
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(b) (4),
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
7Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936398
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Unscheduled Visit on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936399
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Dec-23-2020 12:15:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936400
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0936401
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936402
Page 211 of 723
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936403
Page 212 of 723
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936404
Page 213 of 723
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936405
Page 214 of 723
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936406
Page 215 of 723
***Confidential***
Header Text: c4591001
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Dec-22-2020 16:06:18 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936407
Page 216 of 723
***Confidential***
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-23-2020 12:06:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936408
Page 217 of 723
***Confidential***
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-23-2020 12:06:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936409
Page 218 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-23-2020 12:06:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936410
Page 219 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-23-2020 12:06:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936411
Page 220 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-23-2020 12:06:02 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936412
Page 221 of 723
***Confidential***
Header Text: c4591001
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
FormDec-23-2020 12:06:22 (UTC-05:00)
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(b) (4),
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FDA-CBER-2021-5683-0936413
Page 222 of 723
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
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(b) (4),
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FDA-CBER-2021-5683-0936414
Page 223 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
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(b) (4),
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FDA-CBER-2021-5683-0936415
Page 224 of 723
***Confidential***
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
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(b) (4),
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FDA-CBER-2021-5683-0936416
Page 225 of 723
***Confidential***
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936417
Page 226 of 723
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936418
Page 227 of 723
***Confidential***
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936419
Page 228 of 723
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Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0936420
Page 229 of 723
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Visit: POT_COVID_ILL 1 -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936421
Page 230 of 723
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936422
Page 231 of 723
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Visit: POT_COVID_ILL 1 -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936423
Page 232 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936424
Page 233 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936425
Page 234 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936426
Page 235 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936427
Page 236 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936428
Page 237 of 723
***Confidential***
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
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ItemDate User Comment
5.cDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936429
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Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0936430
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936431
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Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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Visit: POT_COVID_ILL 1 -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.eDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0936434
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936435
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936436
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936437
Page 246 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936438
Page 247 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936439
Page 248 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936440
Page 249 of 723
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Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936441
Page 250 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936442
Page 251 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936443
Page 252 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936444
Page 253 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936445
Page 254 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936446
Page 255 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
1Dec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936447
Page 256 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
2Dec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936448
Page 257 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936449
Page 258 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936450
Page 259 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936451
Page 260 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936452
Page 261 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936453
Page 262 of 723
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Visit: POT_COVID_ILL 1 -
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936454
Page 263 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
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FDA-CBER-2021-5683-0936455
Page 264 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936456
Page 265 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936457
Page 266 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0936458
Page 267 of 723
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936459
Page 268 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.cDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0936460
Page 269 of 723
***Confidential***
Header Text: c4591001
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Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.cDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0936461
Page 270 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.cDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936462
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.dDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936463
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936464
Page 273 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936465
Page 274 of 723
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936466
Page 275 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936467
Page 276 of 723
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936468
Page 277 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936469
Page 278 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936470
Page 279 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936471
Page 280 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936472
Page 281 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936473
Page 282 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.fDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936474
Page 283 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936475
Page 284 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936476
Page 285 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936477
Page 286 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936478
Page 287 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.hDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936479
Page 288 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.hDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936480
Page 289 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.hDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936481
Page 290 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.hDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936482
Page 291 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936483
Page 292 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936484
Page 293 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936485
Page 294 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.iDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936486
Page 295 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936487
Page 296 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936488
Page 297 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936489
Page 298 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311151 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.jDec-23-2020 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ea8\Final\Final On: 01-Apr-2021 04:57 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0936490
Page 299 of 723
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/16/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1131 Site Name: (1131) Pri
…[truncated]