Document text
Page 1 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986537
Page 2 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/5/2020
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986538
Page 3 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421044]
2.Birth Date: 1947
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986539
Page 4 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/5/2020
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986540
Page 5 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986541
Page 6 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986542
Page 7 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/1973
Ongoing: NO
End Date:
UNK/UNK/1973
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to penicillin]
Start Date: UNK/UNK/1947
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrial fibrillation]
Start Date: Apr/11/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jul/12/2007
Ongoing: YES
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986543
Page 8 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Blepharitis]
Start Date: Aug/23/2016
Ongoing: YES
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986544
Page 9 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [155.3]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [22.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986545
Page 10 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986546
Page 11 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222144]
3.Randomization Group: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986547
Page 12 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/5/2020
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 [BM7YJX]
5.bSample ID [BM7YJY]
5.cSample ID [BM7YJZ]
5.dSample ID [BLCB81]
5.eSample ID [BLCB82]
5.fSample ID [BLCB83]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986548
Page 13 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/5/2020
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 [BM7YJ1]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986549
Page 14 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/5/2020 10:22
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986550
Page 15 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986551
Page 16 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986552
Page 17 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986553
Page 18 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986554
Page 19 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986555
Page 20 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/29/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986556
Page 21 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPBZ47]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986557
Page 22 of 526
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/29/2020 09:46
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986558
Page 23 of 526
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986559
Page 24 of 526
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/7/2020
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986560
Page 25 of 526
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986561
Page 26 of 526
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BR919Y]
5.bSample ID [BS6SC4]
5.cSample ID [BS6SC5]
5.dSample ID [BS6SC6]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986562
Page 27 of 526
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986563
Page 28 of 526
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BR4793]
5.bSample ID [BRWKG8]
5.cSample ID [BRWKGN]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986564
Page 29 of 526
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986565
Page 30 of 526
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986566
Page 31 of 526
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986567
Page 32 of 526
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986568
Page 33 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986569
Page 34 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/5/2020
2.Date of First Symptom Started: Sep/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/8/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986570
Page 35 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986571
Page 36 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986572
Page 37 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986573
Page 38 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW89564]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986574
Page 39 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986575
Page 40 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986576
Page 41 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Sep/5/2020 NO
Discharge Date:
Sep/7/2020
Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986577
Page 42 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/5/2020
4.Ongoing? NO
Discharge Date:
Sep/7/2020
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986578
Page 43 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986579
Page 44 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986580
Page 45 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Colitis]
Date of Diagnosis:
Sep/5/2020
3.Toxicity Grade: 4
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986581
Page 46 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986582
Page 47 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986583
Page 48 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab
TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.CLINICAL CHE
MISTRY Jennie Sealy H
ospital Sep/5/2020
BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
Not D
one
30 Not D
one 51
28 Not D
one 51
35 Not D
one 64
21 Not D
one 1.1
47 Not D
one 26
48 Not D
one 1.06 Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986584
Page 49 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Jennie Sealy Hospital] Comments
3.Collection Date: Sep/5/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [ ] Comments
Test: C Reactive Protein_PX329
Result: [ ] Comments
Not Done: Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [51] Comments
Not Done: Comments
LNMT Low
[5]
High
[35]
Unit
U/LComments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986585
Page 50 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [51] Comments
Not Done: Comments
LNMT Low
[13]
High
[40]
Unit
U/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [64] Comments
Not Done: Comments
LNMT Low
[34]
High
[122]
Unit
U/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [1.1] Comments
Not Done: Comments
LNMT Low
[0.1]
High
[1.1]
Unit
mg/dLComments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986586
Page 51 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [26] Comments
Not Done: Comments
LNMT Low
[7]
High
[23]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [1.06] Comments
Not Done: Comments
LNMT Low
[0.5]
High
[1.04]
Unit
mg/dLComments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986587
Page 52 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986588
Page 53 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986589
Page 54 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986590
Page 55 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986591
Page 56 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986592
Page 57 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986593
Page 58 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986594
Page 59 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1. DELETED Sep/5/2020 Record Identifier: Systolic: Diastolic:
Not Done 134 67 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986595
Page 60 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
2. Sep/5/2020 Record Identifier: Systolic: Diastolic:
1 150 59 Repeating Pages
3. DELETED Sep/5/2020 Record Identifier: Systolic: Diastolic:
1 140 62 Repeating Pages
4. DELETED Sep/5/2020 Record Identifier: Systolic: Diastolic:
1 136 66 Repeating Pages
5. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 153 69 Repeating Pages
6. Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 150 68 Repeating Pages
7. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 157 64 Repeating Pages
8. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 140 67 Repeating Pages
9. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 120 53 Repeating Pages
10. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 121 61 Repeating Pages
11. DELETED Sep/6/2020 Record Identifier: Systolic: Diastolic:
1 117 51 Repeating Pages
12. DELETED Sep/7/2020 Record Identifier: Systolic: Diastolic:
1 127 62 Repeating Pages
13. DELETED Sep/7/2020 Record Identifier: Systolic: Diastolic:
1 117 55 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986596
Page 61 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
14. Sep/7/2020 Record Identifier: Systolic: Diastolic:
1 138 69 Repeating Pages
15. DELETED Sep/7/2020 Record Identifier: Systolic: Diastolic:
1 131 62 Repeating Pages
16. DELETED Sep/7/2020 Record Identifier: Systolic: Diastolic:
1 125 60 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986597
Page 62 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [134] Comments
Diastolic: [67] Comments
Respiratory Rate in
respirations/minute:[16] Comments
Heart Rate in beats/minute: [62] Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986598
Page 63 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [150]
Diastolic: [59]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [57]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986599
Page 64 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [140]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [61]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986600
Page 65 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [136]
Diastolic: [66]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [56]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986601
Page 66 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [153]
Diastolic: [69]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [60]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986602
Page 67 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [150]
Diastolic: [68]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [54]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986603
Page 68 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [157]
Diastolic: [64]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [61]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986604
Page 69 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [140]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [58]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986605
Page 70 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [53]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [60]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986606
Page 71 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [121]
Diastolic: [61]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [55]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986607
Page 72 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [117]
Diastolic: [51]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [57]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986608
Page 73 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [51]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986609
Page 74 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [117]
Diastolic: [55]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [52]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986610
Page 75 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [138]
Diastolic: [69]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [54]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986611
Page 76 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [131]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [55]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986612
Page 77 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125]
Diastolic: [60]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [60]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986613
Page 78 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1. DELETED Sep/5/2020 Record Identifier: Oxygen Saturation
Not Done 98.0 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986614
Page 79 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
2. DELETED Sep/5/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
3. DELETED Sep/5/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
4. DELETED Sep/5/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
5. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
6. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
7. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
8. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
9. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
10. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
11. DELETED Sep/6/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
12. DELETED Sep/7/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
13. DELETED Sep/7/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986615
Page 80 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
14. DELETED Sep/7/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
15. Sep/7/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
16. DELETED Sep/7/2020 Record Identifier: Oxygen Saturation
1 100.0 Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986616
Page 81 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0] Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986617
Page 82 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986618
Page 83 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986619
Page 84 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986620
Page 85 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986621
Page 86 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986622
Page 87 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986623
Page 88 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986624
Page 89 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986625
Page 90 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986626
Page 91 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/6/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986627
Page 92 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986628
Page 93 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986629
Page 94 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986630
Page 95 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986631
Page 96 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986632
Page 97 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986633
Page 98 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986634
Page 99 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986635
Page 100 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986636
Page 101 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986637
Page 102 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986638
Page 103 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986639
Page 104 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BR91GC]
5.bSample ID [BS6SKS]
5.cSample ID [BS6SKT]
5.dSample ID [BS6SKV]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986640
Page 105 of 526
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986641
Page 106 of 526
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986642
Page 107 of 526
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/2/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986643
Page 108 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986644
Page 109 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986645
Page 110 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986646
Page 111 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986647
Page 112 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# CategoryAE Ident
ifierAdverse Even
tStart DateIs the Adverse Event St
ill OngoingForm Instanc
e
1. DELETED ADVERSE E
VENT 1 Injection site r
edness Aug/31/2020 UN
K:UNK YES Repeating
Pages
2. ADVERSE E
VENT 2 Colitis Sep/5/2020 UNK
:UNK YES Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986648
Page 113 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site redness ]
4.Start Date Time: Aug/31/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986649
Page 114 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986650
Page 115 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Colitis]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986651
Page 116 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020348661]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986652
Page 117 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986653
Page 118 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986654
Page 119 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986655
Page 120 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986656
Page 121 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986657
Page 122 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986658
Page 123 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986659
Page 124 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986660
Page 125 of 526
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986661
Page 126 of 526
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986662
Page 127 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986663
Page 128 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986664
Page 129 of 526
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986665
Page 130 of 526
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986666
Page 131 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986667
Page 132 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986668
Page 133 of 526
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986669
Page 134 of 526
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986670
Page 135 of 526
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986671
Page 136 of 526
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986672
Page 137 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986673
Page 138 of 526
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986674
Page 139 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986675
Page 140 of 526
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986676
Page 141 of 526
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986677
Page 142 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/28/2020
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986678
Page 143 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
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(b) (4)
FDA-CBER-2021-5683-0986679
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Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986680
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Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-10-2020 15:26:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986681
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***Confidential***
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-29-2020 09:59:56 (UTC-06:00) Central
Time (US & Canada)Not applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986682
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-29-2020 09:59:56 (UTC-06:00) Central
Time (US & Canada)Not applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986683
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6.aAug-29-2020 09:59:56 (UTC-06:00) Central
Time (US & Canada)Not applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986684
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986685
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986686
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986687
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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FDA-CBER-2021-5683-0986688
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986689
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986690
Page 155 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986691
Page 156 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986692
Page 157 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986693
Page 158 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-18-2020 16:52:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986694
Page 159 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986695
Page 160 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986696
Page 161 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986697
Page 162 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986698
Page 163 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986699
Page 164 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986700
Page 165 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-18-2020 16:55:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986701
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 17:03:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986702
Page 167 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 17:03:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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FDA-CBER-2021-5683-0986703
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 17:03:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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FDA-CBER-2021-5683-0986704
Page 169 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 17:03:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0986705
Page 170 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 17:03:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986706
Page 171 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
FormSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986707
Page 172 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
1Sep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986708
Page 173 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
2Sep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0986709
Page 174 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
3Sep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986710
Page 175 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
4Sep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986711
Page 176 of 526
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.aSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986712
Page 177 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.aSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986713
Page 178 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.aSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986714
Page 179 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.aSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986715
Page 180 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.bSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986716
Page 181 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.bSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986717
Page 182 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.bSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986718
Page 183 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.bSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986719
Page 184 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.cSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986720
Page 185 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.cSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986721
Page 186 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.cSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986722
Page 187 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.cSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986723
Page 188 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.dSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986724
Page 189 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.dSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986725
Page 190 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.dSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986726
Page 191 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.dSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986727
Page 192 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.eSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986728
Page 193 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.eSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986729
Page 194 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.eSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986730
Page 195 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.eSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986731
Page 196 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5 fSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986732
Page 197 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5 fSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986733
Page 198 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5 fSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986734
Page 199 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5 fSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986735
Page 200 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.gSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986736
Page 201 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.gSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986737
Page 202 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.gSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:30 (UTC-06:00) Central
Time (US & Canada)
5.gSep-18-2020 17:03:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986740
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986741
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986742
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986743
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986744
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986745
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986746
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986747
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986748
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986749
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986750
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986751
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986752
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986753
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986754
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986755
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986756
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986757
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986758
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986759
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986760
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986761
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986762
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986763
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986764
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986765
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986766
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986767
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986768
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986769
Page 234 of 526
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
5.gSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0986774
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986775
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986776
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0986777
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986778
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986779
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986780
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986781
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986782
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986783
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jSep-18-2020 17:05:03 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986784
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormNov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
FormSep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986785
Page 250 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Nov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
1Sep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986786
Page 251 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aNov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
2.aSep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986787
Page 252 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aNov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
2.aSep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986788
Page 253 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aNov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
2.aSep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986789
Page 254 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aNov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)
2.aSep-18-2020 17:10:32 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986790
Page 255 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormNov-18-2020 09:12:30 (UTC-06:00) Central
Time (US & Canada)
FormSep-18-2020 17:10:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986791
Page 256 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Nov-18-2020 09:12:30 (UTC-06:00) Central
Time (US & Canada)
1Sep-18-2020 17:10:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986792
Page 257 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Deleted
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2.aNov-18-2020 09:12:30 (UTC-06:00) Central
Time (US & Canada)
2.aSep-18-2020 17:10:46 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986793
Page 258 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986794
Page 259 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986795
Page 260 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986796
Page 261 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 17:10:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986797
Page 262 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986798
Page 263 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986799
Page 264 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986800
Page 265 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986801
Page 266 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986802
Page 267 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986803
Page 268 of 526
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Sep-18-2020 17:11:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986804
Page 269 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 Mar-12-2021 16:10:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Mar-09-2021 13:55:19 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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 Jan-26-2021 15:55:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Jan-22-2021 07:59:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986805
Page 270 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
N/A Nov-18-2020 09:08:26 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Oct-12-2020 11:45:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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 Sep-17-2020 13:27:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Sep-16-2020 16:47:01 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986806
Page 271 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-05-2020 17:05:54
(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
Aug-05-2020 17:05:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986807
Page 272 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-05-2020 17:06:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986808
Page 273 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 04:55:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed event added in AE CRF
Sep-10-2020 17:08:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Sep-10-2020 05:56:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020348661
Colitis(onset
date:05Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-05-2020 17:05:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11421044Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 17:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 17:06:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986809
Page 274 of 526
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-05-2020 17:06:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-05-2020 17:06:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986810
Page 275 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-05-2020 17:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986811
Page 276 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-05-2020 17:07:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-05-2020 17:07:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-05-2020 17:07:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986812
Page 277 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-05-2020 17:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hysterectomy
Start Date: UNK/UNK/197
3
Ongoing: NO
End Date:
UNK/UNK/
1973Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-05-2020 17:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-05-2020 17:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-05-2020 17:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1973Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986813
Page 278 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-05-2020 17:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1973Initial Entry
1.b
Date Location User Value Reason
Aug-06-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Allergy to peni
cillin
Start Date: UNK/UNK/19
47
Ongoing: YESInitial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986814
Page 279 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy to penicillinInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1947Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-06-2020 16:46:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Atrial fibrillat
ion
Start Date: Apr/11/2015
Ongoing: YESInitial Entry
090177e196ae3e3d\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986815
Page 280 of 526
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11
…[truncated]