Document text
Page 1 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837250
Page 2 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837251
Page 3 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12641133]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837252
Page 4 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837253
Page 5 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837254
Page 6 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837255
Page 7 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy - aspirin]
Start Date: UNK/UNK/1956
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1982
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837256
Page 8 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy - shellfish]
Start Date: UNK/UNK/2014
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/1991
Ongoing: YES
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837257
Page 9 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [68.9]
3.Unit: kg
4.Height: [171.5]
5.Unit: cm
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837258
Page 10 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [255762]
3.Randomization Group: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837259
Page 11 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BNWCST]
5.bSample ID [BNWCSV]
5.cSample ID [BPYCFL]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837260
Page 12 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BPYCFJ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837261
Page 13 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 11:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837262
Page 14 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837263
Page 15 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837264
Page 16 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837265
Page 17 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BM92RR]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837266
Page 18 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/28/2020 09:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837267
Page 19 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837268
Page 20 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BM9314]
5.bSample ID [BRSS95]
5.cSample ID [BRSS96]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837269
Page 21 of 390
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837270
Page 22 of 390
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837271
Page 23 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837272
Page 24 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837273
Page 25 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837274
Page 26 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837275
Page 27 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837276
Page 28 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/6/2020
2.Date of First Symptom
Started:Nov/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837277
Page 29 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837278
Page 30 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Coll
ectionSpecimen
TypeSpecimen Collectio
n LocationAssay Code and D
escriptionDevice Ty
peForm Instanc
e
1.Not Applica
ble Not Applic
able Not Applicable Not Applicable Not Appli
cable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837279
Page 31 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837280
Page 32 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [CV35551]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837281
Page 33 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 performed.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837282
Page 34 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837283
Page 35 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837284
Page 36 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Id
entifierCon Non-Drug Treatments
Pre-specifiedTreatmen
tTreatmen
tStart Dat
eForm Instanc
e
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837285
Page 37 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837286
Page 38 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837287
Page 39 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical
Event:Subcategory of Clinical
EventDiagnosis Obta
inedToxicity Gr
adeForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837288
Page 40 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837289
Page 41 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applica
ble Not App
licable Not Appl
icable Not App
licable Sponsor-Defi
ned IdentifierTest:Result:
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable
Not Applicabl
e Not App
licable Not App
licable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837290
Page 42 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837291
Page 43 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837292
Page 44 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837293
Page 45 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837294
Page 46 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.Not Applic
able Not Applicab
le Not App
licable Not Ap
plicable
Sponsor-Def
ined Identifi
erTest:Result:
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837295
Page 47 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Result:
Not Applicab
le Not Ap
plicable
Not Ap
plicable
Not Applicab
le Not Ap
plicable
Not Ap
plicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837296
Page 48 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837297
Page 49 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837298
Page 50 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837299
Page 51 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837300
Page 52 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837301
Page 53 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837302
Page 54 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837303
Page 55 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837304
Page 56 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837305
Page 57 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837306
Page 58 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assess
mentArterial Blood Gases P
aO2FiO2 (Fraction of Inhaled Ox
ygen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837307
Page 59 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837308
Page 60 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart Da
teForm Instan
ce
1.Not Applicable Not Applicable
Not Applicable Not Applica
ble Not Appl
icable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837309
Page 61 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837310
Page 62 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessme
ntLocation of Assessme
ntImaging Meth
odOverall Assessme
ntForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837311
Page 63 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837312
Page 64 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837313
Page 65 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BRSSJT]
5.bSample ID [BRSSJV]
5.cSample ID [BM92FH]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837314
Page 66 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837315
Page 67 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837316
Page 68 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837317
Page 69 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837318
Page 70 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837319
Page 71 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837320
Page 72 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Iden
tifierAdverse Eve
ntStart DateIs the Adverse Event S
till OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Headache Sep/29/2020 U
NK:UNK NO
End Date Time:
Sep/30/2020 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Nausea Sep/29/2020 U
NK:UNK NO
End Date Time:
Sep/30/2020 UNK:
UNK
Repeating
Pages
3.ADVERSE
EVENT 3 Myocardial In
farction Feb/22/2021 02
:17 NO
End Date Time:
Feb/28/2021 12:34
Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837321
Page 73 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Headache]
4.Start Date Time: Sep/29/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837322
Page 74 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837323
Page 75 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Nausea]
4.Start Date Time: Sep/29/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837324
Page 76 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837325
Page 77 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Myocardial Infarction]
4.Start Date Time: Feb/22/2021 02:17
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/28/2021 12:34
6.Toxicity Grade: 4
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837326
Page 78 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[N/A]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837327
Page 79 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[2021236452]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837328
Page 80 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837329
Page 81 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837330
Page 82 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart D
ateForm Instan
ce
1.1 VACCINATIO
NS NO Influenza va
ccine Oct/20/
2020 Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837331
Page 83 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Influenza vaccine]
5.Date: Oct/20/2020
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837332
Page 84 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837333
Page 85 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837334
Page 86 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatme
ntStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837335
Page 87 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837336
Page 88 of 390
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837337
Page 89 of 390
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837338
Page 90 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837339
Page 91 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837340
Page 92 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837341
Page 93 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837342
Page 94 of 390
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837343
Page 95 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837344
Page 96 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837345
Page 97 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837346
Page 98 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837347
Page 99 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837348
Page 100 of 390
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837349
Page 101 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837350
Page 102 of 390
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837351
Page 103 of 390
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837352
Page 104 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837353
Page 105 of 390
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837354
Page 106 of 390
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Albertson Approved Mar-10-2021 15:41:49 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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.
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837355
Page 107 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-10-2020 16:07:31 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837356
Page 108 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837357
Page 109 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837358
Page 110 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837359
Page 111 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837360
Page 112 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837361
Page 113 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837362
Page 114 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837363
Page 115 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837364
Page 116 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837365
Page 117 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-09-2020 14:52:01 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837366
Page 118 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837367
Page 119 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837368
Page 120 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837369
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Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837370
Page 122 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837371
Page 123 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837372
Page 124 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-09-2020 14:53:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837373
Page 125 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:53:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837374
Page 126 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:53:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837375
Page 127 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:53:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837376
Page 128 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:53:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837377
Page 129 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:53:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837378
Page 130 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837379
Page 131 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837380
Page 132 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837381
Page 133 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837382
Page 134 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837383
Page 135 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837384
Page 136 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837385
Page 137 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837386
Page 138 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837387
Page 139 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837388
Page 140 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837389
Page 141 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837390
Page 142 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837391
Page 143 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837392
Page 144 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837393
Page 145 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837394
Page 146 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837395
Page 147 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837396
Page 148 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837397
Page 149 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837398
Page 150 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837399
Page 151 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837400
Page 152 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837401
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837402
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***Confidential***
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837403
Page 155 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837404
Page 156 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837405
Page 157 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837406
Page 158 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837407
Page 159 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837408
Page 160 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837409
Page 161 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837410
Page 162 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:53:57 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837411
Page 163 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837412
Page 164 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837413
Page 165 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837414
Page 166 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837415
Page 167 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837416
Page 168 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837417
Page 169 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837418
Page 170 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837419
Page 171 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837420
Page 172 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837421
Page 173 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837422
Page 174 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837423
Page 175 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837424
Page 176 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837425
Page 177 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837426
Page 178 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837427
Page 179 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837428
Page 180 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837429
Page 181 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837430
Page 182 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837431
Page 183 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837432
Page 184 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837433
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Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837434
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***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837435
Page 187 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837436
Page 188 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837437
Page 189 of 390
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837438
Page 190 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837439
Page 191 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837440
Page 192 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837441
Page 193 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837442
Page 194 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837443
Page 195 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837444
Page 196 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837445
Page 197 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837446
Page 198 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837447
Page 199 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837448
Page 200 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837449
Page 201 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837450
Page 202 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837451
Page 203 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837452
Page 204 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837453
Page 205 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837454
Page 206 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837455
Page 207 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-09-2020 14:54:12 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837456
Page 208 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837457
Page 209 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837458
Page 210 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837459
Page 211 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837460
Page 212 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837461
Page 213 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-09-2020 14:54:27 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837462
Page 214 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:54:38 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837463
Page 215 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:54:38 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837464
Page 216 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-09-2020 14:54:38 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837465
Page 217 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:54:52 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837466
Page 218 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:54:52 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837467
Page 219 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:54:52 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837468
Page 220 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:54:52 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837469
Page 221 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837470
Page 222 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837471
Page 223 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837472
Page 224 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837473
Page 225 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837474
Page 226 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837475
Page 227 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-09-2020 14:55:03 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837476
Page 228 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-09-2020 14:55:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837477
Page 229 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-09-2020 14:55:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837478
Page 230 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-09-2020 14:55:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837479
Page 231 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-09-2020 14:55:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837480
Page 232 of 390
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/06/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-09-2020 14:55:17 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837481
Page 233 of 390
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Albertson Approved Mar-10-2021 15:41:49 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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-29-2021 14:01:38 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Jan-22-2021 16:06:26 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837482
Page 234 of 390
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, TimothyAlbertson, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend
that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Dec-07-2020 13:53:32 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Albertson Approved Nov-11-2020 15:58:41 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend
that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Nov-09-2020 14:50:29 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837483
Page 235 of 390
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Timothy
Albertson Approved Nov-06-2020 17:28:28 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyAlbertson, 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.
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837484
Page 236 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020
10:04:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020
10:04:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837485
Page 237 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020
10:04:46
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/9/2020Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837486
Page 238 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020
10:04:32
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12641133Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020
10:04:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020
10:05:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020
10:05:04
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANIInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837487
Page 239 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US &
Canada)SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020
10:05:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837488
Page 240 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
16:07:23
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837489
Page 241 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020
16:07:46
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020
16:07:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020
16:07:46
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837490
Page 242 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020
16:08:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Allergy -
aspirin
Start Date: UNK/UN
K/1956
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:08:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:08:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Allergy - aspirinInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837491
Page 243 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-10-2020
16:08:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1956Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020
16:08:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-10-2020
16:08:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Asthma
Start Date: UNK/UN
K/1982
Ongoing: YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837492
Page 244 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:08:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:08:15
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020
16:08:15
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1982Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020
16:08:15
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837493
Page 245 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c
Date Location User Value Reason
Sep-10-2020
16:08:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Hyperlipi
demia
Start Date: UNK/UN
K/1990
Ongoing: YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837494
Page 246 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:08:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:08:33
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020
16:08:33
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020
16:08:33
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837495
Page 247 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d
Date Location User Value Reason
Sep-10-2020
16:08:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Allergy - s
hellfish
Start Date: UNK/UN
K/2014
Ongoing: YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837496
Page 248 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:08:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:08:52
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Allergy - shellfishInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020
16:08:52
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020
16:08:52
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837497
Page 249 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e
Date Location User Value Reason
Sep-10-2020
16:09:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:GERD
Start Date: UNK/UN
K/1991
Ongoing: YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837498
Page 250 of 390
***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: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:09:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:09:03
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020
16:09:03
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020
16:09:03
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837499
Page 251 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
68.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-11-2020
16:03:30ACV0PFEINFP6000 Data Entry:
171.5Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837500
Page 252 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-08:00) Pacific
Time (US &
Canada)
5. Unit:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.4Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 36.4
Temperature
Unit:C
Temperature
Location::FOREH
EADInitial Entry
7.a Record Identifier:
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837501
Page 253 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
16:03:30
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837502
Page 254 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020
16:09:24
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020
16:09:24
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
255762Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837503
Page 255 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
08:21:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
08:21:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
08:21:33
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
08:21:23
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837504
Page 256 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
08:21:23
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
08:21:33
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWCSTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
08:21:33
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BNWCSTInitial Entry
5.b
Date Location User Value Reason
Sep-11-2020
08:21:46
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWCSVInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837505
Page 257 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
08:21:46
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BNWCSVInitial Entry
5.c
Date Location User Value Reason
Sep-11-2020
08:22:03
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYCFLInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
08:22:03
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPYCFLInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837506
Page 258 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
08:20:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
08:20:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
08:21:05
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
08:20:55
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837507
Page 259 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020
08:20:55
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
08:21:05
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYCFJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
08:21:05
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BPYCFJInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837508
Page 260 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020 11:29Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837509
Page 261 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION PE
RIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837510
Page 262 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-11-2020
16:04:28
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837511
Page 263 of 390
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020
16:09:31
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT COL
LECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837512
Page 264 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020
11:15:07
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837513
Page 265 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.4
Temperature
Unit:C
Temperature
Location::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837514
Page 266 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-28-2020
11:15:17
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837515
Page 267 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
11:53:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
11:53:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
11:53:32
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
11:53:24
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4)
FDA-CBER-2021-5683-0837516
Page 268 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-28-2020
11:53:24
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
11:53:32
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM92RRInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
11:53:32
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BM92RRInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0837517
Page 269 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020 09:24Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837518
Page 270 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION PE
RIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837519
Page 271 of 390
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-28-2020
11:15:36
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837520
Page 272 of 390
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
02:54:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Illness visit was
completed
Nov-09-2020
14:55:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Illness visit was
completed
6Nov2020.
EDC updated.
Nov-09-2020
11:26:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary:
Subject
reported "Yes"
for the question
"Have you
experienced any
of the
following?” for
the COVID-19
symptoms or
diagnosis on
06Nov2020.
But there is no
COVID Illness
visit reported in
the database.
Please clarify.
Oct-30-2020
15:11:31
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Oct/30/2020Initial Entry
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0837521
Page 273 of 390
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Pacific Time (US
& Canada)
090177e196ae3009\Final\Final On: 01-Apr-2021 03:57 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0837522
Page 274 of 390
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1264 Site Name: (1264) University of California Davis Health
Subject No: 12641133 Subject I
…[truncated]