125742 S1 M5 CRF c4591001 1218 12181001

Document text

Page 1 of 464
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823004
Page 2 of 464
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/19/2020
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823005
Page 3 of 464
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12181001]
2.Birth Date: /1988
3.Sex: FEMALE
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:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823006
Page 4 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823007
Page 5 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823008
Page 6 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823009
Page 7 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:[pre-diabetes]
Start Date: Jul/31/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[supraventricular tachycardia]
Start Date: Apr/24/2003
Ongoing: NO
End Date:
Apr/24/2003
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acid reflux]
Start Date: Aug/15/2014
Ongoing: NO
End Date:
Apr/30/2020
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic hip pain]
Start Date: Aug/15/2014
Ongoing: YES
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823010
Page 8 of 464
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:[hiatal hernia repair]
Start Date: Sep/UNK/2018
Ongoing: NO
End Date:
Sep/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Morbid obesity]
Start Date: Dec/17/2009
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholelithiasis]
Start Date: Mar/9/2020
Ongoing: NO
End Date:
Jan/21/2021
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823011
Page 9 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [273.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [42.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823012
Page 10 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823013
Page 11 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [110585]
3.Randomization Group: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823014
Page 12 of 464
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/19/2020
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 [BR8NFH]
5.bSample ID [BS72N5]
5.cSample ID [BS72N4]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823015
Page 13 of 464
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/19/2020
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 [BR8NFG]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823016
Page 14 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/19/2020 15:44
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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823017
Page 15 of 464
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823018
Page 16 of 464
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823019
Page 17 of 464
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823020
Page 18 of 464
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823021
Page 19 of 464
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/11/2020
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 [BR8NGG]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823022
Page 20 of 464
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/11/2020 11:00
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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823023
Page 21 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823024
Page 22 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8NX3]
5.bSample ID [BS72DK]
5.cSample ID [BS72DL]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823025
Page 23 of 464
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823026
Page 24 of 464
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823027
Page 25 of 464
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823028
Page 26 of 464
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823029
Page 27 of 464
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823030
Page 28 of 464
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823031
Page 29 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823032
Page 30 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/22/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823033
Page 31 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823034
Page 32 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823035
Page 33 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823036
Page 34 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:[Staff collected swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823037
Page 35 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:
Dec/21/2020
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 [BR8NXN]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823038
Page 36 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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?NO
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823039
Page 37 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823040
Page 38 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823041
Page 39 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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?NO
3.Toxicity Grade: 3
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823042
Page 40 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823043
Page 41 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823044
Page 42 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823045
Page 43 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823046
Page 44 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823047
Page 45 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823048
Page 46 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823049
Page 47 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823050
Page 48 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823051
Page 49 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823052
Page 50 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823053
Page 51 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823054
Page 52 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823055
Page 53 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823056
Page 54 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Dec/21/2020 Record Identifier: Systolic: Diastolic:
1  110  84 Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823057
Page 55 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 2. DELETED Dec/21/2020 Record Identifier: Systolic: Diastolic:
1  110  84 Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823058
Page 56 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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: Dec/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [110]
Diastolic: [84]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [88]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823059
Page 57 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Deleted, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
Vital Signs
1.Date: Dec/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [110]
Diastolic: [84]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [88]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823060
Page 58 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Dec/21/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823061
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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: Dec/21/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823062
Page 60 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done  Not Done  Not Done  Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823063
Page 61 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823064
Page 62 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823065
Page 63 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823066
Page 64 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823067
Page 65 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823068
Page 66 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823069
Page 67 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/4/2020
2.Date of First Symptom Started: Nov/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/6/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823070
Page 68 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
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Page 69 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823072
Page 70 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823073
Page 71 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[This was originally captured as an AE and no swab obtained.] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823074
Page 72 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[This was originally captured as an AE and no swab obtained.] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823075
Page 73 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823076
Page 74 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823077
Page 75 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823078
Page 76 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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?NO
3.Toxicity Grade: 1
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823079
Page 77 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823080
Page 78 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823081
Page 79 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823082
Page 80 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823083
Page 81 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823084
Page 82 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823085
Page 83 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823086
Page 84 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823087
Page 85 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823088
Page 86 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823089
Page 87 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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.      Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823090
Page 88 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823091
Page 89 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823092
Page 90 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823093
Page 91 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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.        Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823094
Page 92 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823095
Page 93 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/22/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823096
Page 94 of 464
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/22/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:
Jan/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 [BR8NJR]
5.bSample ID [BS72HV]
5.cSample ID [BS72HW]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823097
Page 95 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823098
Page 96 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823099
Page 97 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# CategoryAE Ident
ifierAdverse Eve
ntStart DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1. ADVERSE E
VENT 1  Abdominal p
ain Nov/3/2020 UN
K:UNK NO
End Date Time:
Nov/6/2020 UNK:UN
K
 Repeating
Pages
 2. DELETED ADVERSE E
VENT 2  Diarrhea  Nov/4/2020 UN
K:UNK NO
End Date Time:
Nov/6/2020 UNK:UN
K
 Repeating
Pages
 3. ADVERSE E
VENT 3  Nausea  Nov/4/2020 UN
K:UNK NO
End Date Time:
Nov/6/2020 UNK:UN
K
 Repeating
Pages
 4. ADVERSE E
VENT 4  Acute cholec
ystitis Jan/18/2021 UN
K:UNK NO
End Date Time:
Jan/21/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823100
Page 98 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Abdominal pain]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823101
Page 99 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823102
Page 100 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823103
Page 101 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823104
Page 102 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Nov/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823105
Page 103 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823106
Page 104 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute cholecystitis]
4.Start Date Time: Jan/18/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/21/2021 UNK:UNK
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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823107
Page 105 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[Cholelithiasis]
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?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021065050]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823108
Page 106 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823109
Page 107 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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[ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823110
Page 108 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823111
Page 109 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823112
Page 110 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823113
Page 111 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823114
Page 112 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823115
Page 113 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823116
Page 114 of 464
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823117
Page 115 of 464
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823118
Page 116 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823119
Page 117 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823120
Page 118 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823121
Page 119 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823122
Page 120 of 464
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823123
Page 121 of 464
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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?
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823124
Page 122 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823125
Page 123 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823126
Page 124 of 464
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823127
Page 125 of 464
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823128
Page 126 of 464
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823129
Page 127 of 464
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823130
Page 128 of 464
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823131
Page 129 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823132
Page 130 of 464
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823133
Page 131 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823134
Page 132 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/29/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823135
Page 133 of 464
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823136
Page 134 of 464
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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: [ ]
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823137
Page 135 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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/14/2020
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823138
Page 136 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0823139
Page 137 of 464
***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: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 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
 Approved Mar-10-2021 15:24:15 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823140
Page 138 of 464
***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, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-21-2020 10:28:08 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823141
Page 139 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823142
Page 140 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823143
Page 141 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823144
Page 142 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823145
Page 143 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823146
Page 144 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823147
Page 145 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823148
Page 146 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823149
Page 147 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823150
Page 148 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Dec-21-2020 11:38:59 (UTC-07:00) Mountain
Time (US & Canada)A covid test was not performed during the visit.
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823151
Page 149 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823152
Page 150 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823153
Page 151 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823154
Page 152 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823155
Page 153 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823156
Page 154 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823157
Page 155 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-21-2020 11:42:39 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823158
Page 156 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 11:43:35 (UTC-07:00) Mountain
Time (US & Canada)none
Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823159
Page 157 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 11:43:35 (UTC-07:00) Mountain
Time (US & Canada)none
Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823160
Page 158 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 11:43:35 (UTC-07:00) Mountain
Time (US & Canada)none
Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823161
Page 159 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 11:43:35 (UTC-07:00) Mountain
Time (US & Canada)none
Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823162
Page 160 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 11:43:35 (UTC-07:00) Mountain
Time (US & Canada)none
Not Applicable
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823163
Page 161 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823164
Page 162 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823165
Page 163 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823166
Page 164 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823167
Page 165 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823168
Page 166 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823169
Page 167 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823170
Page 168 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823171
Page 169 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823172
Page 170 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823173
Page 171 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823174
Page 172 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823175
Page 173 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823176
Page 174 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823177
Page 175 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823178
Page 176 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823179
Page 177 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823180
Page 178 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823181
Page 179 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823182
Page 180 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823183
Page 181 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823184
Page 182 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823185
Page 183 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823186
Page 184 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823187
Page 185 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823188
Page 186 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823189
Page 187 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823190
Page 188 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823191
Page 189 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823192
Page 190 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823193
Page 191 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823194
Page 192 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823195
Page 193 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:03 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823196
Page 194 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823197
Page 195 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823198
Page 196 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823199
Page 197 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823200
Page 198 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823201
Page 199 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823202
Page 200 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823203
Page 201 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823204
Page 202 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823205
Page 203 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823206
Page 204 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823207
Page 205 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823208
Page 206 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823209
Page 207 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823210
Page 208 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823211
Page 209 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823212
Page 210 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823213
Page 211 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823214
Page 212 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823215
Page 213 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823216
Page 214 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823217
Page 215 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823218
Page 216 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823219
Page 217 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823220
Page 218 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823221
Page 219 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823222
Page 220 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823223
Page 221 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823224
Page 222 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823225
Page 223 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823226
Page 224 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823227
Page 225 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823228
Page 226 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823229
Page 227 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823230
Page 228 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823231
Page 229 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823232
Page 230 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823233
Page 231 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823234
Page 232 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823235
Page 233 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823236
Page 234 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823237
Page 235 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823238
Page 236 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823239
Page 237 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823240
Page 238 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jDec-21-2020 11:44:30 (UTC-07:00) Mountain
Time (US & Canada)not performed at ER visit
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823241
Page 239 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 12:00:46 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823242
Page 240 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 12:00:46 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823243
Page 241 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 12:00:46 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823244
Page 242 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 12:00:46 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823245
Page 243 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823246
Page 244 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823247
Page 245 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823248
Page 246 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823249
Page 247 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823250
Page 248 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823251
Page 249 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Dec-21-2020 12:01:14 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823252
Page 250 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-21-2020 12:01:57 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823253
Page 251 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-21-2020 12:01:57 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823254
Page 252 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Dec-21-2020 12:01:57 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823255
Page 253 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Dec-21-2020 12:01:57 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823256
Page 254 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Dec-21-2020 12:01:57 (UTC-07:00) Mountain
Time (US & Canada)none
Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823257
Page 255 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823258
Page 256 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823259
Page 257 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823260
Page 258 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823261
Page 259 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823262
Page 260 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823263
Page 261 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823264
Page 262 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823265
Page 263 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823266
Page 264 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Feb-09-2021 12:20:15 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823267
Page 265 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-11-2021 07:46:13 (UTC-07:00) Mountain
Time (US & Canada)
FormFeb-09-2021 12:21:09 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823268
Page 266 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-11-2021 07:46:13 (UTC-07:00) Mountain
Time (US & Canada)
1Feb-09-2021 12:21:09 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823269
Page 267 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Feb-11-2021 07:46:13 (UTC-07:00) Mountain
Time (US & Canada)
2Feb-09-2021 12:21:09 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823270
Page 268 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Feb-11-2021 07:46:13 (UTC-07:00) Mountain
Time (US & Canada)
3Feb-09-2021 12:21:09 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823271
Page 269 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Feb-11-2021 07:46:13 (UTC-07:00) Mountain
Time (US & Canada)
4Feb-09-2021 12:21:09 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823272
Page 270 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-11-2021 08:34:07 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
FormFeb-10-2021 16:45:38 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
FormFeb-09-2021 12:21:29 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823273
Page 271 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-11-2021 08:34:07 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
1Feb-09-2021 12:21:29 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823274
Page 272 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Feb-11-2021 08:34:07 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
2Feb-09-2021 12:21:29 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823275
Page 273 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Feb-11-2021 08:34:07 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
3Feb-09-2021 12:21:29 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823276
Page 274 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Feb-11-2021 08:34:07 (UTC-07:00) Mountain
Time (US & Canada)We were instructed by our CRA and by a query
to construct a visit based on historical
information. There was never a visit, so no nasal
swabs were collected.
4Feb-09-2021 12:21:29 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823277
Page 275 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823278
Page 276 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823279
Page 277 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823280
Page 278 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823281
Page 279 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823282
Page 280 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823283
Page 281 of 464
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/09/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Feb-09-2021 12:22:33 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0823284
Page 282 of 464
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 15:24:15 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-10-2021 13:31:25 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-10-2021 13:27:35 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-04-2021 14:32:03 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e82\Final\Final On: 01-Apr-2021 04:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0823285
Page 283 of 464
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1218 Site Name: (1218) Johns Hopkins Center for American Indian Health
Subject No: 12181001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
 Approved Mar-04-2021 14:29:00 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-01-2021 09:08:57 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-29-2021 20:38:47 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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
…[truncated]