Document text
Page 1 of 618
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825512
Page 2 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/12/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825513
Page 3 of 618
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12211002]
2.Birth Date: 1977
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825514
Page 4 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825515
Page 5 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825516
Page 6 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825517
Page 7 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Stent placement]
Start Date: Jul/UNK/2019
Ongoing: NO
End Date:
Jul/UNK/2019
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Circumcision]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2020
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jul/15/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: Jul/15/2020
Ongoing: YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825518
Page 8 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jul/15/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Type 2]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BPH]
Start Date: UNK/UNK/2019
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kidney Stones]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
Oct/UNK/2019
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congesutive Heart Failure]
Start Date: Jul/UNK/2019
Ongoing: YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825519
Page 9 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [307.4]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [40.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825520
Page 10 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [107094]
3.Randomization Group: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825521
Page 11 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BR8BP0]
5.bSample ID [BS71YG]
5.cSample ID [BS71YH]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825522
Page 12 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BR8BNZ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825523
Page 13 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Oct/13/2020 11:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825524
Page 14 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825525
Page 15 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825526
Page 16 of 618
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825527
Page 17 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825528
Page 18 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Nov/2/2020 09:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825529
Page 19 of 618
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825530
Page 20 of 618
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
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 [BR8BX9]
5.bSample ID [BS723Y]
5.cSample ID [BS723Z]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825531
Page 21 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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_A
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825532
Page 22 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/3/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/20/2020
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825533
Page 23 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825534
Page 24 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/3/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825535
Page 25 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/3/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825536
Page 26 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Patient in hospital on 3 Nov. and was unable to do self swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825537
Page 27 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Collected at V2, Nov.2 because patient admitted to hospital on Nov.3 with
COVID-19 pneumonia. No self or site nasal swab collected on Nov. 3 illness
visit, which was a televisit.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8BR7]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825538
Page 28 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825539
Page 29 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Nov/3/2020 NO
Discharge Date:
Nov/6/2020
Repeating Pages
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(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/3/2020
4.Ongoing? NO
Discharge Date:
Nov/6/2020
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(b) (4)
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Page 31 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825542
Page 32 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825543
Page 33 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Viral Pneumonia secondary to COVID-19]
Date of Diagnosis:
Nov/3/2020
3.Toxicity Grade: 3
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(b) (4)
FDA-CBER-2021-5683-0825544
Page 34 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825545
Page 35 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825546
Page 36 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category f
or Lab Tes
tVendor NameCollect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICAL
CHEMIST
RY Rehoboth McKinley Christian
Hospital, 1901 Red Rock Dr, Ga
llup NM 87301 Nov/3/
2020 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 <0.
5
30 Alanine Amin
otransferase_P
X30 50
28 Aspartate Ami
notransferase_
PX28 54
35 Alkaline Phos
phatase_PX35
140
21 Bilirubin_PX2
1 0.5
47 Blood Urea Ni
trogen_PX47 11
48 Creatinine_PX
48 0.6 Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825547
Page 37 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Rehoboth McKinley Christian Hospital, 1901 Red Rock Dr, Gallup NM 87301]
3.Collection Date: Nov/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [<0.5]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [50]
Not Done:
LNMT Low
[0]
High
[50]
Unit
U/L
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825548
Page 38 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [54]
Not Done:
LNMT Low
[17]
High
[59]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [140]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825549
Page 39 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [11]
Not Done:
LNMT Low
[9]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.6]
Not Done:
LNMT Low
[0.7]
High
[1.3]
Unit
mg/dL
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
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Page 40 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category f
or Lab Te
stVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY Rehoboth McKinley Christian Hos
pital, 1901 Red Rock Dr, Gallup N
M 87301 Nov/3/2
020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglob
in_PX1 16.
1
2 Hematocri
t_PX2 48.
4
3 Erythrocy
tes_PX3 5.4
1
5 Platelets_
PX5 198
7 Leukocyte
s_PX7 5.7
0
608 Neutrophi
ls_PX608 3.8
609 Eosinophi
ls_PX609 0.0
612 Monocyte
s_PX612 1.0
610 Basophils
_PX610 0.0
611 Lymphoc
ytes_PX6
11 0.8 Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825551
Page 41 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Rehoboth McKinley Christian Hospital, 1901 Red Rock Dr, Gallup NM 87301]
3.Collection Date: Nov/3/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [16.1]
Not Done:
LNMT Low
[14.0]
High
[18.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [48.4]
Not Done:
LNMT Low
[41.0]
High
[49.0]
Unit
%
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
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Page 42 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.41]
Not Done:
LNMT Low
[4.00]
High
[5.60]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [198]
Not Done:
LNMT Low
[180]
High
[430]
Unit
10^6/cu mm
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.70]
Not Done:
LNMT Low
[4.5]
High
[11.0]
Unit
10^6/cu mm
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825553
Page 43 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.8]
Not Done:
LNMT Low
[1.5]
High
[8.0]
Unit
10^6/cu mm
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
10^6/cu mm
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.0]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
10^6/cu mm
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825554
Page 44 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^6/cu mm
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.8]
Not Done:
LNMT Low
[0.9]
High
[4.4]
Unit
10^6/cu mm
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825555
Page 45 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Nov/3/2020 Record Identifier: Systolic: Diastolic:
1 153 97 Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825556
Page 46 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [153]
Diastolic: [97]
Respiratory Rate in
respirations/minute:[32]
Heart Rate in beats/minute: [72]
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(b) (4)
FDA-CBER-2021-5683-0825557
Page 47 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Nov/3/2020 Record Identifier: Oxygen Saturation
1 95.0 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0825558
Page 48 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/3/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825559
Page 49 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0825560
Page 50 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825561
Page 51 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0825562
Page 52 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
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Page 53 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of
Assessm
entLocation o
f Assessme
ntImaging
MethodOverall AssessmentForm Insta
nce
1.Nov/3/20
20 CHEST X-RAY NORMAL Repeating
Pages
2.Nov/3/20
20 CHEST CT SCA
N ABNORMAL
If abnormal, specify findings:
Small patchy density in R Upper lobe, likely inflammatory/infect
ious with minor bibasilar subsegmental ateletasis; R coronary ath
erosclerosis vs. stent
Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825564
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/3/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/3/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Small patchy density in R Upper lobe, likely inflammatory/infectious with
minor bibasilar subsegmental ateletasis; R coronary atherosclerosis vs. stent]
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
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(b) (4)
FDA-CBER-2021-5683-0825567
Page 57 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/28/2021
2.Date of First Symptom Started: Feb/26/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/2/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
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(b) (4)
FDA-CBER-2021-5683-0825568
Page 58 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]
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(b) (4)
FDA-CBER-2021-5683-0825569
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Mar/4/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0825570
Page 60 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Mar/4/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [Cepheid IQC4PLEX] Comments
9.Trade Name Other, Specify: [ ] Comments
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(b) (4)
FDA-CBER-2021-5683-0825571
Page 61 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/27/2021
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 [CV55142]
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FDA-CBER-2021-5683-0825572
Page 62 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825573
Page 63 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
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
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825574
Page 64 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825575
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825576
Page 66 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825577
Page 67 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825578
Page 68 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Mar/4/2021
3.Toxicity Grade: 1
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825580
Page 70 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825581
Page 71 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825582
Page 72 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825583
Page 73 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825584
Page 74 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825585
Page 75 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825586
Page 76 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825587
Page 77 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825588
Page 78 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825589
Page 79 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825590
Page 80 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825591
Page 81 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825592
Page 82 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825593
Page 83 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825594
Page 84 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825595
Page 85 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825596
Page 86 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825597
Page 87 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825598
Page 88 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825599
Page 89 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825600
Page 90 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825601
Page 91 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825602
Page 92 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825603
Page 93 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825604
Page 94 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
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 [BR8BX8]
5.bSample ID [BS723W]
5.cSample ID [BS723X]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825605
Page 95 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825606
Page 96 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825607
Page 97 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# CategoryAE Identi
fierAdverse E
ventStart DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1. DELETED ADVERSE E
VENT 1 COVID-19
Nov/1/2020 UNK
:UNK YES Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825608
Page 98 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[COVID-19 ]
4.Start Date Time: Nov/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825609
Page 99 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Viral infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020427759 ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825610
Page 100 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825611
Page 101 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825612
Page 102 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. DELETED Repeating
Pages
2. DELETED Repeating
Pages
3. DELETED Repeating
Pages
4. DELETED Repeating
Pages
5. DELETED Repeating
Pages
6. DELETED Repeating
Pages
7. DELETED Repeating
Pages
8. DELETED Repeating
Pages
9. DELETED Repeating
Pages
10. DELETED Repeating
Pages
11. DELETED Repeating
Pages
12. DELETED Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825613
Page 103 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825614
Page 104 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825615
Page 105 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825616
Page 106 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825617
Page 107 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825618
Page 108 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825619
Page 109 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825620
Page 110 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825621
Page 111 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825622
Page 112 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825623
Page 113 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825624
Page 114 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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: //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825625
Page 115 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Def
ined Identifi
erCategory for MedicationConcomitant Medi
cations Pre-specifi
edName of Me
dicationDose De
scriptio
nForm Insta
nce
1. DELETED 1 CORTICOSTEROIDS NO Dexamethaso
ne (Decadron
) 6 Repeating
Pages
2. DELETED 2 CORTICOSTEROIDS NO Dexamethaso
ne 6 Repeating
Pages
3. DELETED 3 CONCOMITANT IMMU
NOSUPPRESSIVE THER
APY NO Remdesivir 200 Repeating
Pages
4. DELETED 4 CONCOMITANT IMMU
NOSUPPRESSIVE THER
APY NO Remdesivir 100 Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825626
Page 116 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Dexamethasone (Decadron) ]
5.Dose: [6]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: INTRAVENOUS
9.Start Date: Nov/3/2020
10.Ongoing? NO
End Date:
Nov/6/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825627
Page 117 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Dexamethasone ]
5.Dose: [6]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Nov/7/2020
10.Ongoing? NO
End Date:
Nov/10/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825628
Page 118 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Remdesivir ]
5.Dose: [200]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Nov/3/2020
10.Ongoing? NO
End Date:
Nov/3/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825629
Page 119 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [4]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Remdesivir ]
5.Dose: [100]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: INTRAVENOUS
9.Start Date: Nov/4/2020
10.Ongoing? NO
End Date:
Nov/6/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825630
Page 120 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Start Date Form Instance
1.Not Applica
ble Not Applicable Not Applicable Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825631
Page 121 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825632
Page 122 of 618
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825633
Page 123 of 618
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825634
Page 124 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825635
Page 125 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825636
Page 126 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825637
Page 127 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825638
Page 128 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825639
Page 129 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825640
Page 130 of 618
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825641
Page 131 of 618
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825642
Page 132 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825643
Page 133 of 618
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825644
Page 134 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825645
Page 135 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825646
Page 136 of 618
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825647
Page 137 of 618
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825648
Page 138 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825649
Page 139 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/1/2021
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825650
Page 140 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825651
Page 141 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825652
Page 142 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
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 [BRJ42L]
5.bSample ID [BS6ZGG]
5.cSample ID [BS6ZGH]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825653
Page 143 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
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 [BRJ42H]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825654
Page 144 of 618
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/1/2021 12:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825655
Page 145 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825656
Page 146 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
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 [BRJ43Y]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825657
Page 147 of 618
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/22/2021 16:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825658
Page 148 of 618
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825659
Page 149 of 618
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825660
Page 150 of 618
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825661
Page 151 of 618
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825662
Page 152 of 618
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825663
Page 153 of 618
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825664
Page 154 of 618
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825665
Page 155 of 618
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/4/2020
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825666
Page 156 of 618
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825667
Page 157 of 618
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jane Halpern Approved Mar-09-2021 10:12:16 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JaneHalpern, 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.
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825668
Page 158 of 618
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-15-2020 09:07:01 (UTC-07:00) Mountain
Time (US & Canada)Per protocol, visit 1 can be split over two days
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825669
Page 159 of 618
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-14-2020 12:23:54 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825670
Page 160 of 618
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-17-2020 11:27:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825671
Page 161 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825672
Page 162 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825673
Page 163 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825674
Page 164 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825675
Page 165 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825676
Page 166 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825677
Page 167 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-11-2020 08:25:44 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Received only 2L O2 by nasal canula
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825678
Page 168 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-11-2020 09:37:35 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825679
Page 169 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-11-2020 09:37:35 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
1Nov-11-2020 09:32:45 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern No severe illness parameters present
1Nov-11-2020 09:32:07 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825680
Page 170 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-11-2020 09:37:35 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825681
Page 171 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-11-2020 09:37:35 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825682
Page 172 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-11-2020 09:37:35 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825683
Page 173 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-11-2020 09:31:25 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern No ABG's done.
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825684
Page 174 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-11-2020 09:31:25 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern No ABG's done.
Not Applicable
1Nov-11-2020 09:27:22 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825685
Page 175 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-11-2020 09:31:25 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern No ABG's done.
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825686
Page 176 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-11-2020 09:31:25 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern No ABG's done.
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825687
Page 177 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825688
Page 178 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825689
Page 179 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825690
Page 180 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825691
Page 181 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825692
Page 182 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825693
Page 183 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/03/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Nov-11-2020 09:18:11 (UTC-07:00) Mountain
Time (US & Canada)Jane Halpern Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825694
Page 184 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
FormMar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825695
Page 185 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
1Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825696
Page 186 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
2Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825697
Page 187 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
3Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825698
Page 188 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
4Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825699
Page 189 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
5Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825700
Page 190 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
6Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825701
Page 191 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
7Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825702
Page 192 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
8Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825703
Page 193 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Mar-05-2021 15:42:03 (UTC-07:00) Mountain
Time (US & Canada)
9Mar-01-2021 16:24:22 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825704
Page 194 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 16:28:29 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825705
Page 195 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-01-2021 16:28:29 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825706
Page 196 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-01-2021 16:28:29 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825707
Page 197 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-01-2021 16:28:29 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825708
Page 198 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-01-2021 16:28:29 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825709
Page 199 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825710
Page 200 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825711
Page 201 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825712
Page 202 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825713
Page 203 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825714
Page 204 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825715
Page 205 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Mar-01-2021 16:29:41 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825716
Page 206 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 16:30:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825717
Page 207 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-01-2021 16:30:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825718
Page 208 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-01-2021 16:30:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825719
Page 209 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-01-2021 16:30:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825720
Page 210 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-01-2021 16:30:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825721
Page 211 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825722
Page 212 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825723
Page 213 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825724
Page 214 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825725
Page 215 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825726
Page 216 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825727
Page 217 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825728
Page 218 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825729
Page 219 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825730
Page 220 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825731
Page 221 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825732
Page 222 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825733
Page 223 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825734
Page 224 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825735
Page 225 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825736
Page 226 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825737
Page 227 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825738
Page 228 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825739
Page 229 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825740
Page 230 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825741
Page 231 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825742
Page 232 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825743
Page 233 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825744
Page 234 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825745
Page 235 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825746
Page 236 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825747
Page 237 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825748
Page 238 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825749
Page 239 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825750
Page 240 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825751
Page 241 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825752
Page 242 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825753
Page 243 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:13 (UTC-07:00) Mountain
Time (US & Canada)Not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825754
Page 244 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825755
Page 245 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Mar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825756
Page 246 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Mar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825757
Page 247 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Mar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825758
Page 248 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Mar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825759
Page 249 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825760
Page 250 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825761
Page 251 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825762
Page 252 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825763
Page 253 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825764
Page 254 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825765
Page 255 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825766
Page 256 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825767
Page 257 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825768
Page 258 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825769
Page 259 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825770
Page 260 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825771
Page 261 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825772
Page 262 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825773
Page 263 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825774
Page 264 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825775
Page 265 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825776
Page 266 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825777
Page 267 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825778
Page 268 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825779
Page 269 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825780
Page 270 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825781
Page 271 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825782
Page 272 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825783
Page 273 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825784
Page 274 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825785
Page 275 of 618
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211002 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gMar-01-2021 16:31:53 (UTC-07:00) Mountain
Time (US & Canada)not medically attended
Not Applicable
090177e196ae4040\Final\Final On: 01-Apr-2021 05:
…[truncated]