Document text
Page 1 of 489
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808009
Page 2 of 489
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808010
Page 3 of 489
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11451063]
2.Birth Date: /1985
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808011
Page 4 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808012
Page 5 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808013
Page 6 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808014
Page 7 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Seasonal allergies]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[c-section delivery]
Start Date: Jan/10/2018
Ongoing: NO
End Date:
Jan/10/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Wisdom teeth removal]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypothyroidism, controlled]
Start Date: UNK/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Depression, controlled]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808015
Page 8 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [146.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [22.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808016
Page 9 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
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:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808017
Page 10 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [72416]
3.Randomization Group: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808018
Page 11 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[4.0ml, 1.8ml and 1.4ml collected in retained aliquots]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1KC0]
5.bSample ID [BPJ19K]
5.cSample ID [BPJ19L]
5.dSample ID [BPJ19M]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808019
Page 12 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP1KCG]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808020
Page 13 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 14:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808021
Page 14 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808022
Page 15 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020 Comments
2.Erroneous Visit Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808023
Page 16 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808024
Page 17 of 489
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/24/2020
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:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808025
Page 18 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/24/2020
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 [BRD6M5]
5.bSample ID [BRD6M5 ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808026
Page 19 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/24/2020 09:59
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808027
Page 20 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808028
Page 21 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BNW4VB]
5.bSample ID [BNW4V9]
5.cSample ID [BNW4V8]
5.dSample ID [BM9C0K]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808029
Page 22 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808030
Page 23 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/2/2020
2.Date of First Symptom Started: Oct/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [new or increased nasal congestion]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808031
Page 24 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/2/2020 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808032
Page 25 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [JHH SOFT LABS CLIA-certified lab]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808033
Page 26 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW84850]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808034
Page 27 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self nasal swab was collected by volunteer]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808035
Page 28 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: 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: YES
Number of Visits or Contacts:
[1]
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808036
Page 29 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808037
Page 30 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808038
Page 31 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808039
Page 32 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808040
Page 33 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808041
Page 34 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest: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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808042
Page 35 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808043
Page 36 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808044
Page 37 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808045
Page 38 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808046
Page 39 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest: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
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808047
Page 40 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808048
Page 41 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808049
Page 42 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808050
Page 43 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808051
Page 44 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808052
Page 45 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808053
Page 46 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808054
Page 47 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808055
Page 48 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808056
Page 49 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808057
Page 50 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808058
Page 51 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808059
Page 52 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808060
Page 53 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808061
Page 54 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808062
Page 55 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808063
Page 56 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808064
Page 57 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/29/2020
2.Date of First Symptom Started: Oct/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/8/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [new or increased sputum production]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808065
Page 58 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSymptoms - Other Text: [new or increased nasal congestion]
5.cSymptoms - Other Text: [new or increased nasal discharge]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808066
Page 59 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/29/202
0 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808067
Page 60 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/29/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808068
Page 61 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV48014]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808069
Page 62 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab was collected by patient]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808070
Page 63 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: 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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808071
Page 64 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808072
Page 65 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808073
Page 66 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808074
Page 67 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808075
Page 68 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808076
Page 69 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808077
Page 70 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808078
Page 71 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808079
Page 72 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808080
Page 73 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808081
Page 74 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808082
Page 75 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808083
Page 76 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808084
Page 77 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808085
Page 78 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808086
Page 79 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808087
Page 80 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808088
Page 81 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808089
Page 82 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808090
Page 83 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808091
Page 84 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1LD4]
5.bSample ID [BNW4WX]
5.cSample ID [BNW4WY]
5.dSample ID [BNW4WZ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808092
Page 85 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Dec/03/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808093
Page 86 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Dec/03/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/3/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNW4VV]
5.bSample ID [BRD6M8]
5.cSample ID [BNW4VW]
5.dSample ID [BNW4VX]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808094
Page 87 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808095
Page 88 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808096
Page 89 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/7/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808097
Page 90 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808098
Page 91 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808099
Page 92 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808100
Page 93 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Paresthesias of Sk
in Sep/21/2020 UNK:U
NK NO
End Date Time:
Sep/28/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 disc herniation Sep/14/2020 UNK:U
NK YES Repeating
Pages
3.ADVERSE EVE
NT 3 dizziness Sep/24/2020 UNK:U
NK NO
End Date Time:
Sep/25/2020 UNK:UNK
Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808101
Page 94 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Paresthesias of Skin]
4.Start Date Time: Sep/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 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
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENTComments
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808102
Page 95 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[2020373981]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808103
Page 96 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[disc herniation]
4.Start Date Time: Sep/14/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
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:
[Disc Herniation at L5-S1]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808104
Page 97 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808105
Page 98 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[dizziness]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/25/2020 UNK:UNK
6.Toxicity Grade: 2
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:
CONCOMITANT DRUG TREATMENT
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
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808106
Page 99 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808107
Page 100 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication Er
rorStart DateIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1.Not Applica
ble Not Applicable Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808108
Page 101 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of Medication
Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication given? Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808109
Page 102 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. DELETED Repeating
Pages
2. DELETED 2 VACCINATIONS
NO no conmev vax i
s given Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808110
Page 103 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ] Comments
2.Category: Comments
3.Concomitant Medications
Pre-specified: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).[ ] Comments
5.Date: // Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808111
Page 104 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2] Comments
2.Category: VACCINATIONS Comments
3.Concomitant Medications
Pre-specified:NO 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).[no conmev vax is given ] Comments
5.Date: // Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808112
Page 105 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descripti
onForm Instanc
e
1. DELETED 1 CORTICOSTER
OIDS NO Methylpredni
solone 24 mg to 4 mg
tapering Repeating
Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808113
Page 106 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Methylprednisolone ]
5.Dose: [24 mg to 4 mg tapering ]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Sep/19/2020
10.Ongoing? NO
End Date:
Sep/24/2020
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808114
Page 107 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808115
Page 108 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808116
Page 109 of 489
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808117
Page 110 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808118
Page 111 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808119
Page 112 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808120
Page 113 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808121
Page 114 of 489
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808122
Page 115 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808123
Page 116 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808124
Page 117 of 489
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808125
Page 118 of 489
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808126
Page 119 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808127
Page 120 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808128
Page 121 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808129
Page 122 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808130
Page 123 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/21/2021
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808131
Page 124 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808132
Page 125 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808133
Page 126 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/21/2021
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:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808134
Page 127 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BM9C26]
5.bSample ID [BNVL11]
5.cSample ID [BNVL12]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808135
Page 128 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BM9C1W]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808136
Page 129 of 489
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/21/2021 10:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808137
Page 130 of 489
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808138
Page 131 of 489
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/11/2021
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:
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808139
Page 132 of 489
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BM9C48]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808140
Page 133 of 489
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/11/2021 13:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808141
Page 134 of 489
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808142
Page 135 of 489
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808143
Page 136 of 489
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808144
Page 137 of 489
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808145
Page 138 of 489
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808146
Page 139 of 489
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808147
Page 140 of 489
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/11/2021 Comments
2.Phase of Disposition: OPEN LABEL TREATMENT Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808148
Page 141 of 489
***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: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/7/2021
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808149
Page 142 of 489
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808150
Page 143 of 489
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0808151
Page 144 of 489
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-31-2020 15:41:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0808152
Page 145 of 489
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-24-2020 11:35:01 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-30-2020 11:28:10 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808153
Page 146 of 489
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-24-2020 11:35:01 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-30-2020 11:28:10 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808154
Page 147 of 489
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Nov-24-2020 11:35:01 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-30-2020 11:28:10 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808155
Page 148 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808156
Page 149 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808157
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808158
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808159
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808160
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808161
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-09-2020 10:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808162
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:47:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808163
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:47:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808164
Page 157 of 489
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:47:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808165
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:47:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808166
Page 159 of 489
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:47:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808167
Page 160 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808168
Page 161 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808169
Page 162 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808170
Page 163 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808171
Page 164 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808172
Page 165 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808173
Page 166 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808174
Page 167 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808175
Page 168 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808176
Page 169 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808177
Page 170 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808178
Page 171 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808179
Page 172 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808180
Page 173 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808181
Page 174 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808182
Page 175 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808183
Page 176 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808184
Page 177 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808185
Page 178 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808186
Page 179 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808187
Page 180 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808188
Page 181 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808189
Page 182 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808190
Page 183 of 489
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808191
Page 184 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808192
Page 185 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808193
Page 186 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808194
Page 187 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808195
Page 188 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808196
Page 189 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808197
Page 190 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808198
Page 191 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808199
Page 192 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808200
Page 193 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808201
Page 194 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808202
Page 195 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808203
Page 196 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808204
Page 197 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808205
Page 198 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808206
Page 199 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808207
Page 200 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808208
Page 201 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808209
Page 202 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808210
Page 203 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808211
Page 204 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808212
Page 205 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808213
Page 206 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808214
Page 207 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808215
Page 208 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808216
Page 209 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808217
Page 210 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808218
Page 211 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808219
Page 212 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808220
Page 213 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808221
Page 214 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808222
Page 215 of 489
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808223
Page 216 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808224
Page 217 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808225
Page 218 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808226
Page 219 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808227
Page 220 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808228
Page 221 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808229
Page 222 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808230
Page 223 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808231
Page 224 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808232
Page 225 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808233
Page 226 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808234
Page 227 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808235
Page 228 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808236
Page 229 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808237
Page 230 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808238
Page 231 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808239
Page 232 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808240
Page 233 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808241
Page 234 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808242
Page 235 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808243
Page 236 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808244
Page 237 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-09-2020 10:46:23 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808245
Page 238 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808246
Page 239 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808247
Page 240 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808248
Page 241 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808249
Page 242 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808250
Page 243 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-09-2020 10:46:04 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808251
Page 244 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:45:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808252
Page 245 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:45:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808253
Page 246 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-09-2020 10:45:41 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808254
Page 247 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:47:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808255
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Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:47:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
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Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:47:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808257
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:47:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808258
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Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
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Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808262
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808263
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808264
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-09-2020 10:47:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808265
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 10:47:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808266
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***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 10:47:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808267
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***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 10:47:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808268
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***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 10:47:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808269
Page 262 of 489
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/02/2020Form: IMAGING - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 10:47:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808270
Page 263 of 489
***Confidential***
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Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808271
Page 264 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808272
Page 265 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808273
Page 266 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808274
Page 267 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808275
Page 268 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808276
Page 269 of 489
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-30-2020 09:53:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808277
Page 270 of 489
***Confidential***
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Sep-30-2020 13:59:50 (UTC-05:00) Eastern Time
(US & Canada)Kawsar Talaat Cyclobenzaprine, 10 mg po daily and
Methylprednisolone dose pack; 24 mg to 4 mg
tapering course given 19 September to 24
September.
9Sep-30-2020 13:57:43 (UTC-05:00) Eastern Time
(US & Canada)Kawsar Talaat Cyclobenzaprine, 10 mg po daily and
Methylprednisolone dose pack; 24 mg to 4 mg
tapering course.
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0808278
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***Confidential***
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Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808279
Page 272 of 489
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808280
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808281
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808282
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808283
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***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
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Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808284
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808285
Page 278 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808286
Page 279 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808287
Page 280 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808288
Page 281 of 489
***Confidential***
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Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Oct-09-2020 14:53:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808289
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Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormOct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Oct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Oct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
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Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Oct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808293
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Oct-14-2020 10:18:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
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FDA-CBER-2021-5683-0808294
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Oct-26-2020 11:21:17 (UTC-05:00) Eastern Time
(US & Canada)
5Oct-20-2020 09:33:36 (UTC-05:00) Eastern Time
(US & Canada)Not Done
5Oct-09-2020 14:54:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0808295
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***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormOct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0808296
Page 289 of 489
***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Oct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0808297
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***Confidential***
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Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Oct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
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FDA-CBER-2021-5683-0808298
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***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Oct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
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FDA-CBER-2021-5683-0808299
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***Confidential***
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Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
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FDA-CBER-2021-5683-0808300
Page 293 of 489
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Oct-28-2020 10:51:37 (UTC-05:00) Eastern Time
(US & Canada)
5Oct-27-2020 09:50:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808301
Page 294 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:07:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808302
Page 295 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 14:07:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808303
Page 296 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808304
Page 297 of 489
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-21-2021 14:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-0808305
Page 298 of 489
***Confidential***
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Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451063 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-21-2021 14:08:51 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe4\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0808306
Page 299 of 489
***Confidential***
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Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREAT
…[truncated]