Document text
Page 1 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938882
Page 2 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938883
Page 3 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11351265]
2.Birth Date: /1980
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:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0938884
Page 4 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938885
Page 5 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938886
Page 6 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938887
Page 7 of 356
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/1996
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[stuttering]
Start Date: UNK/UNK/1986
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[chocolate food allergy]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938888
Page 8 of 356
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[vasectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right ACL tear]
Start Date: Aug/UNK/2020
Ongoing: YES
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938889
Page 9 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [99.4]
3.Unit: kg
4.Height: [181.0]
5.Unit: cm
6.Body Mass Index: [30.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938890
Page 10 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [78372]
3.Randomization Group: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938891
Page 11 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9T8F]
5.bSample ID [BLCW72]
5.cSample ID [BLCW73]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938892
Page 12 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9T8R]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938893
Page 13 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 10:07
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
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938894
Page 14 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938895
Page 15 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938896
Page 16 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938897
Page 17 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP93JX]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938898
Page 18 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 09:37
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
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938899
Page 19 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938900
Page 20 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP93HC]
5.bSample ID [BMNXB1]
5.cSample ID [BMNXB2]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938901
Page 21 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938902
Page 22 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/5/2020
2.Date of First Symptom
Started:Oct/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/3/2020
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? NO
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938903
Page 23 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938904
Page 24 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938905
Page 25 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938906
Page 26 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV05043]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938907
Page 27 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[subject submitted self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938908
Page 28 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts: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
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938909
Page 29 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938910
Page 30 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938911
Page 31 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938912
Page 32 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938913
Page 33 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938914
Page 34 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938915
Page 35 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938916
Page 36 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938917
Page 37 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938918
Page 38 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938919
Page 39 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938920
Page 40 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938921
Page 41 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938922
Page 42 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938923
Page 43 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938924
Page 44 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938925
Page 45 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938926
Page 46 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938927
Page 47 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938928
Page 48 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938929
Page 49 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938930
Page 50 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/30/2020
2.Date of First Symptom
Started:Nov/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938931
Page 51 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938932
Page 52 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938933
Page 53 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938934
Page 54 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/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 [CV08733]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938935
Page 55 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[subject self swabbed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938936
Page 56 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts: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
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938937
Page 57 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938938
Page 58 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1.Not Done Not Done Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938939
Page 59 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938940
Page 60 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938941
Page 61 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938942
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical
Event:Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
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(b) (4)
FDA-CBER-2021-5683-0938943
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938944
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938945
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938946
Page 66 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938947
Page 67 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938948
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938949
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938950
Page 70 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938951
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938952
Page 72 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938953
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938954
Page 74 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938955
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938956
Page 76 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938957
Page 77 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/03/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938958
Page 78 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFZCW]
5.bSample ID [BMNXGW]
5.cSample ID [BMNXGY]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938959
Page 79 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Dec/28/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938960
Page 80 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BRCD6Y]
5.bSample ID [BSGB3Y]
5.cSample ID [BSGB3Z]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938961
Page 81 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938962
Page 82 of 356
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938963
Page 83 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938964
Page 84 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938965
Page 85 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938966
Page 86 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938967
Page 87 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# CategoryAE Id
entifie
rAdverse E
ventStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
1. ADVERS
E EVEN
T 1 pain on rig
ht knee Oct/30/202
0 UNK:UN
K NO
End Date Time:
Dec/28/2020 U
NK:UNK
Repeating
Pages
2. DELETED ADVERS
E EVEN
T 2 Sinus tachy
cardia Jan/23/202
1 15:00 NO
End Date Time:
Jan/27/2021 17
:00
Repeating
Pages
3. ADVERS
E EVEN
T 3 Hypertensi
on Jan/26/202
1 UNK:UN
K NO
End Date Time:
Jan/27/2021 U
NK:UNK
Repeating
Pages
4. ADVERS
E EVEN
T 4 accelerated
hypertensio
n Jan/23/202
1 15:00 NO
End Date Time:
Jan/27/2021 17
:00
Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938968
Page 88 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[pain on right knee]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/28/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938969
Page 89 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ACL tear]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938970
Page 90 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938971
Page 91 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Sinus tachycardia ]
4.Start Date Time: Jan/23/2021 15:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/27/2021 17:00
6.Toxicity Grade: 2
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938972
Page 92 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[idiopathic ]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938973
Page 93 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938974
Page 94 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Hypertension]
4.Start Date Time: Jan/26/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938975
Page 95 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[stress]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938976
Page 96 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938977
Page 97 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[accelerated hypertension]
4.Start Date Time: Jan/23/2021 15:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/27/2021 17:00
6.Toxicity Grade: 3
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938978
Page 98 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital
anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
YES
Did this serious event result in persistent or
significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Idiopathic]Comments
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938979
Page 99 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?: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[2021107081]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938980
Page 100 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938981
Page 101 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938982
Page 102 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938983
Page 103 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938984
Page 104 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938985
Page 105 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938986
Page 106 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938987
Page 107 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938988
Page 108 of 356
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938989
Page 109 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938990
Page 110 of 356
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938991
Page 111 of 356
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938992
Page 112 of 356
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938993
Page 113 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938994
Page 114 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938995
Page 115 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938996
Page 116 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938997
Page 117 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938998
Page 118 of 356
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0938999
Page 119 of 356
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939000
Page 120 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939001
Page 121 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/10/2021
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939002
Page 122 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939003
Page 123 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939004
Page 124 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSG9VG]
5.bSample ID [BSG9VH]
5.cSample ID [BR9MKF]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939005
Page 125 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9MKW]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939006
Page 126 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 10:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939007
Page 127 of 356
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939008
Page 128 of 356
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGVMD]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939009
Page 129 of 356
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/2/2021 09:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939010
Page 130 of 356
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939011
Page 131 of 356
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939012
Page 132 of 356
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939013
Page 133 of 356
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939014
Page 134 of 356
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939015
Page 135 of 356
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939016
Page 136 of 356
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939017
Page 137 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939018
Page 138 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939019
Page 139 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939020
Page 140 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-02-2020 16:19:02 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939021
Page 141 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939022
Page 142 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939023
Page 143 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939024
Page 144 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939025
Page 145 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939026
Page 146 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939027
Page 147 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939028
Page 148 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939029
Page 149 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939030
Page 150 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Oct-05-2020 11:33:28 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939031
Page 151 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939032
Page 152 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939033
Page 153 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939034
Page 154 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939035
Page 155 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939036
Page 156 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939037
Page 157 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939038
Page 158 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939039
Page 159 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939040
Page 160 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Nov-30-2020 17:18:43 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939041
Page 161 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939042
Page 162 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939043
Page 163 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939044
Page 164 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939045
Page 165 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939046
Page 166 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939047
Page 167 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Nov-30-2020 17:22:53 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939048
Page 168 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-30-2020 17:25:04 (UTC-08:00)
Pacific Time (US & Canada)No severe symptoms
FormNov-30-2020 17:24:03 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939049
Page 169 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-30-2020 17:24:03 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939050
Page 170 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-30-2020 17:24:03 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939051
Page 171 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-30-2020 17:24:03 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939052
Page 172 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-30-2020 17:24:03 (UTC-08:00)
Pacific Time (US & Canada)Not Done
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939053
Page 173 of 356
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Mar-03-2021 09:56:40 (UTC-08:00)
Pacific Time (US & Canada)Subject had no previous hx of HTN
and denied any particular trigger for
this episode of high BP. cardiologic
workups in the hospital revealed no
significant pathology. He is currently
monitoring his BP at home and is
under care of a cardiologist.
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0939054
Page 174 of 356
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormFeb-24-2021 15:20:21 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0939055
Page 175 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-03-2021 13:42:42 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter
Winkle Approved Jan-25-2021 09:47:07 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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-30-2020 17:14:51 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939056
Page 176 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
N/A
Peter
Winkle Approved Nov-09-2020 13:25:43 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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-05-2020 14:57:45 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter
Winkle Approved Nov-05-2020 13:19:30 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939057
Page 177 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, PeterWinkle, 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-03-2020 17:37:38 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter
Winkle Approved Nov-02-2020 09:15:43 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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.
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939058
Page 178 of 356
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
N/A Oct-27-2020 14:32:28 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Peter
Winkle Approved Oct-14-2020 09:38:53 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PeterWinkle, 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.
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939059
Page 179 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-02-2020
16:17:33
(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-02-2020
16:17:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939060
Page 180 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
16:17:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/2/2020Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939061
Page 181 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
16:17:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11351265Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
16:17:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1980Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
16:18:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939062
Page 182 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-02-2020
16:18:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
16:18:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939063
Page 183 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020
16:18:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939064
Page 184 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-02-2020
16:19:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
16:19:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
16:19:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939065
Page 185 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
16:19:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:seasonal
allergies
Start Date: UNK/U
NK/1996
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
16:19:54
(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-02-2020
16:19:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
seasonal allergiesInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939066
Page 186 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.a Start Date:
Date Location User Value Reason
Sep-02-2020
16:19:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
16:19:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-02-2020
16:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:stutterin
g
Start Date: UNK/U
NK/198
6
Ongoing: YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939067
Page 187 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020
16:20:16
(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-02-2020
16:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
stutteringInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020
16:20:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1986Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020
16:20:16ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939068
Page 188 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00)
Pacific Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-02-2020
16:20:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:chocolate
food aller
gy
Start Date
:UNK/UN
K/1996
Ongoing: YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939069
Page 189 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020
16:20:47
(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-02-2020
16:20:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
chocolate food allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020
16:20:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020
16:20:47ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939070
Page 190 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00)
Pacific Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-02-2020
16:21:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:vasectomy
Start Date
:UNK/UN
K/2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939071
Page 191 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Sep-02-2020
16:21:18
(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-02-2020
16:21:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-02-2020
16:21:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-02-2020
16:21:18ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939072
Page 192 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00)
Pacific Time (US
& Canada)End Date:
UNK/UNK/2019
1.e
Date Location User Value Reason
Nov-09-2020
13:06:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:right AC
L tear
Start Date: Aug/UN
K/2020
Ongoing: YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939073
Page 193 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Nov-09-2020
13:06:09
(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
Nov-09-2020
13:06:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
right ACL tearInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-09-2020
13:06:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-09-2020
13:06:09ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939074
Page 194 of 356
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00)
Pacific Time (US
& Canada)
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0939075
Page 195 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
99.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939076
Page 196 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
181.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.3Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.3Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939077
Page 197 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
37.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939078
Page 198 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
16:21:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939079
Page 199 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
16:22:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
16:22:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
78372Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939080
Page 200 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
16:22:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
16:22:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020
18:03:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020
16:22:23
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939081
Page 201 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
16:22:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
18:03:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9T8FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
18:03:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9T8FInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939082
Page 202 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-02-2020
18:03:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLCW7
2Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020
18:03:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLCW72Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020
18:03:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BLCW7
3Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020
18:03:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLCW73Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939083
Page 203 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
16:22:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
16:22:31
(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-02-2020
18:04:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-02-2020
16:22:31
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939084
Page 204 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
16:22:31
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
18:04:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9T8
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
18:04:57
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9T8RInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939085
Page 205 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939086
Page 206 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/2/2020 10:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
16:22:48
(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-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939087
Page 207 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
16:22:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939088
Page 208 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
16:23:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939089
Page 209 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
17:34:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939090
Page 210 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.9
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939091
Page 211 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
17:34:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939092
Page 212 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
17:35:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
17:35:10
(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
09:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-26-2020
02:32:40
(UTC-08:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0939093
Page 213 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
17:35:10
(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.
Sep-25-2020
17:35:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
09:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP93JXInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939094
Page 214 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-28-2020
09:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP93JXInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939095
Page 215 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939096
Page 216 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 09:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
17:35:23
(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-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939097
Page 217 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-25-2020
17:35:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939098
Page 218 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
14:32:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939099
Page 219 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020
14:32:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
14:32:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020
18:26:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
14:32:36
(UTC-08:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939100
Page 220 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-27-2020
14:32:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
18:26:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP93H
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
18:26:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP93HCInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939101
Page 221 of 356
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-27-2020
18:26:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BMNXB
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020
18:26:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BMNXB1Initial Entry
5.c
Date Location User Value Reason
Oct-27-2020
18:26:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BMNXB
2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020
18:26:32
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BMNXB2Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939102
Page 222 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020
11:33:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-05-2020
11:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Oct-05-2020
11:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939103
Page 223 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Oct-05-2020
11:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-05-2020
11:32:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939104
Page 224 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Sympto
m Resolved:
Oct/3/2020Initial Entry
4.a
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939105
Page 225 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASEInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939106
Page 226 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)D COUGH
Sympt
om Pre
sent:NO
4.b Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939107
Page 227 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Symp
tom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939108
Page 228 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.d Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939109
Page 229 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.e Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939110
Page 230 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.f Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939111
Page 231 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.g Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARR
HEA
Symptom P
resent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939112
Page 232 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.h Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMIT
ING
Symptom P
resent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939113
Page 233 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.i Symptoms:
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-05-2020
11:33:15
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939114
Page 234 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939115
Page 235 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939116
Page 236 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-05-2020
11:33:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939117
Page 237 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020
11:33:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020
11:33:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:39:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-06-2020
01:15:58
(UTC-08:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0939118
Page 238 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-05-2020
11:33:47
(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.
Oct-05-2020
11:33:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:39:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:CV0504
3Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939119
Page 239 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-07-2020
16:39:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CV05043Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939120
Page 240 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020
11:34:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020
11:34:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020
11:34:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939121
Page 241 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-05-2020
11:34:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
subject submitted self
swabInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939122
Page 242 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939123
Page 243 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:EMER
GENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939124
Page 244 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:PRIMAR
Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PH
YSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939125
Page 245 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Prac
titioner:URGE
NT C
ARE
Occurrence
of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Type of P
ractitioneTELEPH
ONE COInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939126
Page 246 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)r: NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:OT
HE
RInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939127
Page 247 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
& Canada) Occurrence of
Visits or Conta
cts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-05-2020
11:34:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939128
Page 248 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/05/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-05-2020
11:34:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-05-2020
11:34:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-05-2020
11:34:34
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939129
Page 249 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020
17:18:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-30-2020
17:14:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Nov-30-2020
17:14:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939130
Page 250 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-30-2020
17:14:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/30/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-30-2020
17:14:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939131
Page 251 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/30/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/25/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Sympto
m Resolved:
Nov/27/2020Initial Entry
4.a
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939132
Page 252 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pre
sent:YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASEInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939133
Page 253 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Pacific Time (US
& Canada)D COUGH
Sympt
om Pre
sent:NO
4.b Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939134
Page 254 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Symp
tom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:YESInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939135
Page 255 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.d Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939136
Page 256 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.e Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3d59\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939137
Page 257 of 356
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351265 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.f Symptoms:
Date Location User Value Reason
Nov-30-2020
17:16:37
(UTC-08:00)
Pacific Time (US
& Canada)A
…[truncated]