125742 S1 M5 CRF c4591001 1235 12351071

Document text

Page 1 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990298
Page 2 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990299
Page 3 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12351071]
2.Birth Date: 1970
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:
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990300
Page 4 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990301
Page 5 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990302
Page 6 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990303
Page 7 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990304
Page 8 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [240.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [33.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990305
Page 9 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [88827]
3.Randomization Group: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990306
Page 10 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BLD3S3]
5.bSample ID [BLD3S2]
5.cSample ID [BP1D74]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990307
Page 11 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP1D70]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990308
Page 12 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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/14/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990309
Page 13 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990310
Page 14 of 623
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990311
Page 15 of 623
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990312
Page 16 of 623
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990313
Page 17 of 623
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990314
Page 18 of 623
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990315
Page 19 of 623
***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, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/24/2020
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 [BSMPZ4]
5.bSample ID [BP0YK3]
5.cSample ID [BSMPZ2]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990316
Page 20 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990317
Page 21 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/22/2020
2.Date of First Symptom Started: Sep/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/25/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990318
Page 22 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990319
Page 23 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Sep/22/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990320
Page 24 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/22/2020
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: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [LSU EVT Lab- PCR analysis- CLIA-certified lab]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990321
Page 25 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [CV50417]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990322
Page 26 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:[nasal self swab was collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990323
Page 27 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
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?
YES
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990324
Page 28 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  ICU  Sep/22/2020  NO
Discharge Date:
Sep/26/2020
 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990325
Page 29 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Sep/22/2020
4.Ongoing? NO
Discharge Date:
Sep/26/2020
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990326
Page 30 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applica
ble Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990327
Page 31 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990328
Page 32 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 ILLNESS]
Date of Diagnosis:
Sep/22/2020
3.Toxicity Grade: 2
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990329
Page 33 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990330
Page 34 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990331
Page 35 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990332
Page 36 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
 2.CLINICAL
CHEMIST
RY Ochsner LSU Health Shrevepo
rt 1501 Kings Hwy Shreveport,
LA 71103 Sep/22/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 1.3
5 
30  Alanine Amino
transferase_PX
30 97 
28  Aspartate Ami
notransferase_
PX28 44 
35  Alkaline Phosp
hatase_PX35 69 
21  Bilirubin_PX2
1 0.5 
47  Blood Urea Nit
rogen_PX47 13 
48  Creatinine_PX
48 1.0 Repeating
Pages
 3.CLINICAL
CHEMIST
RY Ochsner LSU Health Shrevepo
rt 1501 Kings Hwy Shreveport,
LA 71103 Sep/23/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 1.7
7 
30  Alanine Amino
transferase_PX
30 94 
28  Aspartate Ami
notransferase_
PX28 50 
35  Alkaline Phosp
hatase_PX35 66 
21  Bilirubin_PX2
1 0.4 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990333
Page 37 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Res
ult:
47  Blood Urea Nit
rogen_PX47 12 
48  Creatinine_PX
48 0.8 
 4.CLINICAL
CHEMIST
RY Ochsner LSU Health Shrevepo
rt 1501 Kings Hwy Shreveport,
LA 71103 Sep/24/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 0.7
8 
30  Alanine Amino
transferase_PX
30 78 
28  Aspartate Ami
notransferase_
PX28 40 
35  Alkaline Phosp
hatase_PX35 58 
21  Bilirubin_PX2
1 0.4 
47  Blood Urea Nit
rogen_PX47 9 
48  Creatinine_PX
48 0.7
7 Repeating
Pages
 5.CLINICAL
CHEMIST
RY Ochsner LSU Health Shrevepo
rt 1501 Kings Hwy Shreveport,
LA 71103 Sep/25/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 [ ] 
30  Alanine Amino
transferase_PX
30 81 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990334
Page 38 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab TestVendor NameCollect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Res
ult:
28  Aspartate Ami
notransferase_
PX28 39 
35  Alkaline Phosp
hatase_PX35 62 
21  Bilirubin_PX2
1 0.3 
47  Blood Urea Nit
rogen_PX47 12 
48  Creatinine_PX
48 0.7
3 
 6.CLINICAL
CHEMIST
RY Ochsner LSU Health Shrevepo
rt 1501 Kings Hwy Shreveport,
LA 71103 Sep/26/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329  
30  Alanine Amino
transferase_PX
30 70 
28  Aspartate Ami
notransferase_
PX28 28 
35  Alkaline Phosp
hatase_PX35 60 
21  Bilirubin_PX2
1 0.3 
47  Blood Urea Nit
rogen_PX47 12 
48  Creatinine_PX
48 0.8
0 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990335
Page 39 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990336
Page 40 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990337
Page 41 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990338
Page 42 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990339
Page 43 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport,LA 71103]
3.Collection Date: Sep/22/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.35]
Not Done:
LNMT Low
[0.00]
High
[0.90]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [97]
Not Done:
LNMT Low
[10]
High
[44]
Unit
U/L
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990340
Page 44 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [44]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [69]
Not Done:
LNMT Low
[55]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990341
Page 45 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.0]
Not Done:
LNMT Low
[0.5]
High
[1.40]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990342
Page 46 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport,LA 71103]
3.Collection Date: Sep/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.77]
Not Done:
LNMT Low
[0.00]
High
[0.90]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [94]
Not Done:
LNMT Low
[10]
High
[44]
Unit
U/L
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990343
Page 47 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [50]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [66]
Not Done:
LNMT Low
[55]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990344
Page 48 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [12]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.8]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990345
Page 49 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [0.78]
Not Done:
LNMT Low
[0.00]
High
[0.90]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [78]
Not Done:
LNMT Low
[10]
High
[44]
Unit
U/L
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990346
Page 50 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [40]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [58]
Not Done:
LNMT Low
[55]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990347
Page 51 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [9]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.77]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990348
Page 52 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [81]
Not Done:
LNMT Low
[10]
High
[44]
Unit
U/L
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990349
Page 53 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [39]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [62]
Not Done:
LNMT Low
[55]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990350
Page 54 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [12]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.73]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990351
Page 55 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[0.0]
High
[0.9]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [70]
Not Done:
LNMT Low
[10]
High
[44]
Unit
U/L
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990352
Page 56 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [28]
Not Done:
LNMT Low
[10]
High
[40]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [60]
Not Done:
LNMT Low
[55]
High
[135]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.1]
High
[1.0]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990353
Page 57 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [12]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.80]
Not Done:
LNMT Low
[0.50]
High
[1.40]
Unit
mg/dL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990354
Page 58 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1. DELETED Not Done  Not Done  Not Done
 Not Don
e Sponsor-Defin
ed IdentifierTest:Resul
t:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990355
Page 59 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
 2.HEMATO
LOGY Ochsner LSU Health Shreveport
1501 Kings Hwy Shreveport, LA
71103 Sep/23/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 13.8
 
2  Hematocri
t_PX2 40.5
 
3  Erythrocyt
es_PX3 4.20
 
5  Platelets_
PX5 224 
7  Leukocyte
s_PX7 5.03
 
608  Neutrophil
s_PX608 2.4 
609  Eosinophil
s_PX609 0.0 
612  Monocyte
s_PX612 1.1 
610  Basophils
_PX610 0.03
 
611  Lymphocy
tes_PX611
 1.4 Repeating
Pages
 3.HEMATO
LOGY Ochsner LSU Health Shreveport
1501 Kings Hwy Shreveport, LA
71103 Sep/24/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 13.1
 
2  Hematocri
t_PX2 39.1
 
3  Erythrocyt
es_PX3 4.07
 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990356
Page 60 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Res
ult:
5  Platelets_
PX5 199 
7  Leukocyte
s_PX7 4.01
 
608  Neutrophil
s_PX608 1.4 
609  Eosinophil
s_PX609 0.1 
612  Monocyte
s_PX612 0.8 
610  Basophils
_PX610 0.02
 
611  Lymphocy
tes_PX611
 1.7 
 4.HEMATO
LOGY Ochsner LSU Health Shreveport
1501 Kings Hwy Shreveport, LA
71103 Sep/25/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 14.3
 
2  Hematocri
t_PX2 42.2
 
3  Erythrocyt
es_PX3 4.40
 
5  Platelets_
PX5 217 
7  Leukocyte
s_PX7 4.11
 
608  Neutrophil
s_PX608 1.1 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990357
Page 61 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Res
ult:
609  Eosinophil
s_PX609 0.1 
612  Monocyte
s_PX612 0.6 
610  Basophils
_PX610 0.02
 
611  Lymphocy
tes_PX611
 2.3 
 5.HEMATO
LOGY Ochsner LSU Health Shreveport
1501 Kings Hwy Shreveport, LA
71103 Sep/26/
2020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 14.0
 
2  Hematocri
t_PX2 41.1
 
3  Erythrocyt
es_PX3 4.33
 
5  Platelets_
PX5 211 
7  Leukocyte
s_PX7 4.42
 
608  Neutrophil
s_PX608 1.3 
609  Eosinophil
s_PX609 0.1 
612  Monocyte
s_PX612 0.6 
610  Basophils
_PX610 0.02
 Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990358
Page 62 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Res
ult:
611  Lymphocy
tes_PX611
 2.3 
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990359
Page 63 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990360
Page 64 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990361
Page 65 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990362
Page 66 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990363
Page 67 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990364
Page 68 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990365
Page 69 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.8]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.5]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990366
Page 70 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.20]
Not Done:
LNMT Low
[4.6]
High
[6.2]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [224]
Not Done:
LNMT Low
[150]
High
[350]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.03]
Not Done:
LNMT Low
[3.9]
High
[12.70]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990367
Page 71 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [2.4]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.1]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990368
Page 72 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.03]
Not Done:
LNMT Low
[0.0]
High
[0.20]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.4]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990369
Page 73 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/24/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.1]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [39.1]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990370
Page 74 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.07]
Not Done:
LNMT Low
[4.6]
High
[6.2]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [199]
Not Done:
LNMT Low
[150]
High
[350]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [4.01]
Not Done:
LNMT Low
[3.9]
High
[12.7]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990371
Page 75 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [1.4]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.8]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990372
Page 76 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.02]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.7]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990373
Page 77 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.3]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [42.2]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990374
Page 78 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.40]
Not Done:
LNMT Low
[4.6]
High
[6.2]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [217]
Not Done:
LNMT Low
[150]
High
[350]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [4.11]
Not Done:
LNMT Low
[3.9]
High
[12.7]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990375
Page 79 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [1.1]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.6]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990376
Page 80 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.02]
Not Done:
LNMT Low
[0.0]
High
[0.20]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.3]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990377
Page 81 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Ochsner LSU Health Shreveport 1501 Kings Hwy Shreveport, LA 71103]
3.Collection Date: Sep/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [14.0]
Not Done:
LNMT Low
[12.5]
High
[16.3]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [41.1]
Not Done:
LNMT Low
[36.7]
High
[47.1]
Unit
%
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990378
Page 82 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.33]
Not Done:
LNMT Low
[4.6]
High
[6.2]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [211]
Not Done:
LNMT Low
[150]
High
[350]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [4.42]
Not Done:
LNMT Low
[3.9]
High
[12.7]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990379
Page 83 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [1.3]
Not Done:
LNMT Low
[1.8]
High
[7.7]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.6]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990380
Page 84 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.02]
Not Done:
LNMT Low
[0.0]
High
[0.20]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.3]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990381
Page 85 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1. DELETED  Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990382
Page 86 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 2.Sep/26/2020 Record Identifier: Systolic: Diastolic:
1  118  79 Repeating Pages
 3.Sep/25/2020 Record Identifier: Systolic: Diastolic:
1  182  72 Repeating Pages
 4.Sep/24/2020 Record Identifier: Systolic: Diastolic:
1  120  80 Repeating Pages
 5.Sep/23/2020 Record Identifier: Systolic: Diastolic:
1  145  94 Repeating Pages
 6.Sep/22/2020 Record Identifier: Systolic: Diastolic:
1  131  95 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990383
Page 87 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990384
Page 88 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [118]
Diastolic: [79]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [80]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990385
Page 89 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [182]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[15]
Heart Rate in beats/minute: [90]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990386
Page 90 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [83]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990387
Page 91 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [145]
Diastolic: [94]
Respiratory Rate in
respirations/minute:[11]
Heart Rate in beats/minute: [70]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990388
Page 92 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [131]
Diastolic: [95]
Respiratory Rate in
respirations/minute:[26]
Heart Rate in beats/minute: [111]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990389
Page 93 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 1.Sep/23/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990390
Page 94 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Date: Vital Signs Details Form Instance
 2. DELETED Not Applicable Record Identifier: Oxygen Saturation
1  Not Applicable Repeating Pages
 3. Sep/22/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
 4. Sep/24/2020 Record Identifier: Oxygen Saturation
1  93.0 Repeating Pages
 5. Sep/25/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 6. Sep/26/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990391
Page 95 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990392
Page 96 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990393
Page 97 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990394
Page 98 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990395
Page 99 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990396
Page 100 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/26/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990397
Page 101 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990398
Page 102 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990399
Page 103 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990400
Page 104 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990401
Page 105 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Sep/22/2020  CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
Minimal bibasilar infiltrates
 Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990402
Page 106 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/22/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Minimal bibasilar infiltrates]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990403
Page 107 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990404
Page 108 of 623
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BLD43G]
5.bSample ID [BLD43F]
5.cSample ID [BP1DR4]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990405
Page 109 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990406
Page 110 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990407
Page 111 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/22/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Exclusion Criteria 5]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990408
Page 112 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990409
Page 113 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990410
Page 114 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990411
Page 115 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990412
Page 116 of 623
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990413
Page 117 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990414
Page 118 of 623
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990415
Page 119 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990416
Page 120 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: //
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990417
Page 121 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990418
Page 122 of 623
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990419
Page 123 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990420
Page 124 of 623
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990421
Page 125 of 623
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990422
Page 126 of 623
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990423
Page 127 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990424
Page 128 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990425
Page 129 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990426
Page 130 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990427
Page 131 of 623
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990428
Page 132 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990429
Page 133 of 623
***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, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990430
Page 134 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990431
Page 135 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/18/2020
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990432
Page 136 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990433
Page 137 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/18/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990434
Page 138 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
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 [BP0Y20]
5.bSample ID [BRV43K]
5.cSample ID [BRV43M]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990435
Page 139 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
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 [BP0Y1D]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990436
Page 140 of 623
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/18/2020 09:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990437
Page 141 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990438
Page 142 of 623
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990439
Page 143 of 623
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990440
Page 144 of 623
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990441
Page 145 of 623
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BP0Y6B]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990442
Page 146 of 623
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/8/2021 10:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990443
Page 147 of 623
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990444
Page 148 of 623
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/5/2021
3.Comments: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990445
Page 149 of 623
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990446
Page 150 of 623
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990447
Page 151 of 623
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990448
Page 152 of 623
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990449
Page 153 of 623
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990450
Page 154 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/22/2020
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990451
Page 155 of 623
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990452
Page 156 of 623
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990453
Page 157 of 623
***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: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormSep-14-2020 09:12:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990454
Page 158 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990455
Page 159 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990456
Page 160 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990457
Page 161 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990458
Page 162 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990459
Page 163 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990460
Page 164 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990461
Page 165 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-27-2020 12:47:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990462
Page 166 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-27-2020 12:47:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990463
Page 167 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-27-2020 12:47:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990464
Page 168 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-27-2020 12:47:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990465
Page 169 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-27-2020 12:47:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990466
Page 170 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990467
Page 171 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Sep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990468
Page 172 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Sep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990469
Page 173 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Sep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990470
Page 174 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Sep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990471
Page 175 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.aSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990472
Page 176 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.aSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990473
Page 177 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.aSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990474
Page 178 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.aSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990475
Page 179 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.bSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990476
Page 180 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.bSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990477
Page 181 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.bSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990478
Page 182 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.bSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990479
Page 183 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.cSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990480
Page 184 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.cSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990481
Page 185 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.cSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990482
Page 186 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.cSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990483
Page 187 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.dSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990484
Page 188 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.dSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990485
Page 189 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.dSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990486
Page 190 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.dSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990487
Page 191 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.eSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990488
Page 192 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.eSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990489
Page 193 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.eSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990490
Page 194 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.eSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990491
Page 195 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5 fSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990492
Page 196 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5 fSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990493
Page 197 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5 fSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990494
Page 198 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5 fSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990495
Page 199 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.gSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990496
Page 200 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.gSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990497
Page 201 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.gSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990498
Page 202 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5.gSep-30-2020 14:35:56 (UTC-06:00) Central
Time (US & Canada)Initial log line was inadvertently skipped. First
Chemistry value available is documented on log
line 2.
Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990499
Page 203 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990500
Page 204 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Oct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990501
Page 205 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Oct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990502
Page 206 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Oct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990503
Page 207 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990504
Page 208 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.aOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990505
Page 209 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.aOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990506
Page 210 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.aOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990507
Page 211 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.aOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990508
Page 212 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.bOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990509
Page 213 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.bOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990510
Page 214 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.bOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990511
Page 215 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.bOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990512
Page 216 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.cOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990513
Page 217 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.cOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990514
Page 218 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.cOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990515
Page 219 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5.cOct-27-2020 12:49:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990516
Page 220 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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FDA-CBER-2021-5683-0990546
Page 250 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aOct-13-2020 10:58:09 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990547
Page 251 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-27-2020 12:47:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990548
Page 252 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-27-2020 12:47:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990549
Page 253 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-27-2020 12:47:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990550
Page 254 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-27-2020 12:47:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990551
Page 255 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990552
Page 256 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990553
Page 257 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990554
Page 258 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990555
Page 259 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990556
Page 260 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990557
Page 261 of 623
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Oct-27-2020 12:48:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990558
Page 262 of 623
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormDec-18-2020 13:38:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990559
Page 263 of 623
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormDec-18-2020 13:35:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990560
Page 264 of 623
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Dec-18-2020 13:35:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990561
Page 265 of 623
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormDec-18-2020 13:35:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990562
Page 266 of 623
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Dec-18-2020 13:35:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0990563
Page 267 of 623
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-05-2021 10:01:40 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Jan-20-2021 17:40:29 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-18-2020 13:33:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Dec-03-2020 00:11:41 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990564
Page 268 of 623
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Nov-30-2020 15:14:07 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Nov-24-2020 16:34:39 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-24-2020 09:05:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Nov-13-2020 22:31:02 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 10:37:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990565
Page 269 of 623
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
John Vanchiere  Approved Nov-02-2020 12:04:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-02-2020 09:21:10 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Oct-29-2020 13:59:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-27-2020 12:47:14 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Oct-26-2020 10:06:36 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990566
Page 270 of 623
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-22-2020 15:52:48 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Oct-16-2020 16:17:25 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-16-2020 14:09:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Vanchiere  Approved Oct-16-2020 11:05:06 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990567
Page 271 of 623
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, JohnVanchiere, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0990568
Page 272 of 623
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-14-2020 09:11:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-14-2020 09:11:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990569
Page 273 of 623
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-14-2020 09:11:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/14/2020Initial Entry
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0990570
Page 274 of 623
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1235 Site Name: (1235) LSU Health Shreveport
Subject No: 12351071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-08-2020 07:29:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Event invalidated in SDB.
Issue resolved
Oct-07-2020 05:00:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: Please
submit a follow up AEM
form to have the case
invalidated in Pfizer Safety
database.
Oct-06-2020 08:59:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered There was confusion on
whether to report or not.
The original answer was to
report. After the SAE was
reported, the answer was
changed to not report the
SAE. Instructions given by
CRA and CTM.
Oct-06-2020 06:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020383652
SARS-CoV2
infection(onset
date:22Sep2020)was
reported as serious in
Safety database.Per
Clinical
comment,'COVID19
hospitalisations ARE NOT
reported as SAE.This is not
a valid event for safety.'.
Please confirm
Sep-14-2020 09:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12351071Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
090177e196ae3034\Final\Final On: 01-Apr-2021 04:03 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0990571
Page 275 of 623
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, F
…[truncated]