Document text
Page 1 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806752
Page 2 of 423
***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: 11451042 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/25/2020
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806753
Page 3 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11451042]
2.Birth Date: /1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806754
Page 4 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806755
Page 5 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806756
Page 6 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806757
Page 7 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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:[Allergic to penicillin]
Start Date: UNK/UNK/1976
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to Monosodium glutamate (MSG)]
Start Date: UNK/UNK/1996
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic to sulfur]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: Mar/UNK/2020
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gestational diabetes]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806758
Page 8 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: UNK/UNK/1997
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pre-diabetic]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2015
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anemia]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2012
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stomach ulcers]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806759
Page 9 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gallbladder disease (inflammation)]
Start Date: Jul/UNK/1994
Ongoing: NO
End Date:
Aug/UNK/1994
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Surgery for gallbladder removal]
Start Date: Aug/UNK/1994
Ongoing: NO
End Date:
Aug/UNK/1994
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Roux-en-y gastric bypass]
Start Date: Oct/UNK/1998
Ongoing: NO
End Date:
Oct/UNK/1998
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bypass surgery revision]
Start Date: Jan/UNK/2015
Ongoing: NO
End Date:
Jan/UNK/2015
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806760
Page 10 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEEP surgery]
Start Date: Nov/UNK/2002
Ongoing: NO
End Date:
Nov/UNK/2002
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dilation and curettage (D&C) procedure]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hospitalized for bronchitis]
Start Date: May/UNK/2011
Ongoing: NO
End Date:
May/UNK/2011
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806761
Page 11 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [252.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [39.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806762
Page 12 of 423
***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: 11451042 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/25/2020
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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806763
Page 13 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [64092]
3.Randomization Group: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806764
Page 14 of 423
***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: 11451042 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/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[2.5ml collected for both retained aliquots]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1K85]
5.bSample ID [BP1K9H]
5.cSample ID [BP1K9J]
5.dSample ID [BPJ18F]
5.eSample ID [BPJ18G]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806765
Page 15 of 423
***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: 11451042 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/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1K7Z]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806766
Page 16 of 423
***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: 11451042 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/25/2020 12:27
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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806767
Page 17 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806768
Page 18 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806769
Page 19 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806770
Page 20 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 11451042 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: Sep/15/2020
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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806771
Page 21 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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:
Sep/15/2020
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 [BP1KH1]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806772
Page 22 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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: Sep/15/2020 10:37
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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806773
Page 23 of 423
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806774
Page 24 of 423
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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:
Oct/13/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPJ1J4]
5.bSample ID [BPJ1J5]
5.cSample ID [BPJ1J6]
5.dSample ID [BP1LB7]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806775
Page 25 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: 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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806776
Page 26 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/13/2020
2.Date of First Symptom Started: Oct/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/12/2020
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 nasal congestion] Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806777
Page 27 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSymptoms - Other Text: [new or increased nasal discharge]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806778
Page 28 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806779
Page 29 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806780
Page 30 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: 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: 11451042 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[physician collected the nasal swab today in clinic]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ] Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806781
Page 31 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: 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: 11451042 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:
Oct/13/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW80670]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806782
Page 32 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806783
Page 33 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806784
Page 34 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806785
Page 35 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806786
Page 36 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806787
Page 37 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806788
Page 38 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806789
Page 39 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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: 11451042 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806790
Page 40 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806791
Page 41 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806792
Page 42 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806793
Page 43 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applicable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806794
Page 44 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806795
Page 45 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806796
Page 46 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806797
Page 47 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806798
Page 48 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806799
Page 49 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806800
Page 50 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806801
Page 51 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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 Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806802
Page 52 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806803
Page 53 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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 Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806804
Page 54 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806805
Page 55 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806806
Page 56 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806807
Page 57 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806808
Page 58 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806809
Page 59 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806810
Page 60 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/17/2020Form: 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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806811
Page 61 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/17/2020Form: 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: 11451042 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/17/2020
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 [BNW4WM]
5.bSample ID [BNW4RB]
5.cSample ID [BNW4RC]
5.dSample ID [BRD6LZ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806812
Page 62 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806813
Page 63 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806814
Page 64 of 423
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806815
Page 65 of 423
***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: 11451042 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: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806816
Page 66 of 423
***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: 11451042 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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806817
Page 67 of 423
***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: 11451042 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 [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806818
Page 68 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ongo
ingForm Instance
1.ADVERSE EVEN
T 1 Ileus Dec/25/2020 UNK:UN
K NO
End Date Time:
Dec/28/2020 UNK:UNK
Repeating
Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806819
Page 69 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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)[Ileus]
4.Start Date Time: Dec/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/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:
OTHER
If Other, specify:
[it is not related to vaccine, declared as ileus. Cause is idiopathic.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806820
Page 70 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021082316]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806821
Page 71 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806822
Page 72 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806823
Page 73 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806824
Page 74 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 11451042 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.Date: Not Applicable
//Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806825
Page 75 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806826
Page 76 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806827
Page 77 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806828
Page 78 of 423
***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: 11451042 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?
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806829
Page 79 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806830
Page 80 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806831
Page 81 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806832
Page 82 of 423
***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: 11451042 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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806833
Page 83 of 423
***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: 11451042 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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806834
Page 84 of 423
***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: 11451042 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?
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806835
Page 85 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806836
Page 86 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806837
Page 87 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806838
Page 88 of 423
***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, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 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 other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806839
Page 89 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806840
Page 90 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806841
Page 91 of 423
***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: 11451042 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
[ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806842
Page 92 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806843
Page 93 of 423
***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: 11451042 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/26/2021
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806844
Page 94 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806845
Page 95 of 423
***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: 11451042 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/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806846
Page 96 of 423
***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: 11451042 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/26/2021
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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806847
Page 97 of 423
***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: 11451042 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/26/2021
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 [BM9C2X]
5.bSample ID [BNVL27]
5.cSample ID [BNVL26]
5.dSample ID [BNVL25]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806848
Page 98 of 423
***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: 11451042 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/26/2021
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 [BM9C2R]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806849
Page 99 of 423
***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: 11451042 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/26/2021 11:00
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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806850
Page 100 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806851
Page 101 of 423
***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: 11451042 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/16/2021
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:
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806852
Page 102 of 423
***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: 11451042 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/16/2021
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 [BM9C4F]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806853
Page 103 of 423
***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: 11451042 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/16/2021 10:21
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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806854
Page 104 of 423
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806855
Page 105 of 423
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806856
Page 106 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806857
Page 107 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806858
Page 108 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806859
Page 109 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806860
Page 110 of 423
***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: 11451042 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 :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806861
Page 111 of 423
***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: 11451042 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 Oct/13/2020
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806862
Page 112 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806863
Page 113 of 423
***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: 11451042 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
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806864
Page 114 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-26-2020 09:52:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806865
Page 115 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-14-2020 09:49:51 (UTC-05:00) Eastern Time
(US & Canada)NEW OR INCREASED NASAL CONGESTION
and NEW OR INCREASED NASAL DISCHARGE
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806866
Page 116 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806867
Page 117 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806868
Page 118 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806869
Page 119 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806870
Page 120 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806871
Page 121 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806872
Page 122 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806873
Page 123 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806874
Page 124 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806875
Page 125 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Oct-13-2020 10:58:31 (UTC-05:00) Eastern Time
(US & Canada)volunteer has mild symptoms have not yet done the
COVID 19 test
Not Done
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806876
Page 126 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-14-2020 09:52:31 (UTC-05:00) Eastern Time
(US & Canada)duplicate entry have to remove this
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806877
Page 127 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806878
Page 128 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806879
Page 129 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806880
Page 130 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806881
Page 131 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806882
Page 132 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806883
Page 133 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 11:05:54 (UTC-05:00) Eastern Time
(US & Canada)minor congestion only in the nose
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806884
Page 134 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:07:09 (UTC-05:00) Eastern Time
(US & Canada)not a covid illness nasal congestion
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806885
Page 135 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:07:09 (UTC-05:00) Eastern Time
(US & Canada)not a covid illness nasal congestion
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806886
Page 136 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:07:09 (UTC-05:00) Eastern Time
(US & Canada)not a covid illness nasal congestion
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806887
Page 137 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:07:09 (UTC-05:00) Eastern Time
(US & Canada)not a covid illness nasal congestion
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806888
Page 138 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:07:09 (UTC-05:00) Eastern Time
(US & Canada)not a covid illness nasal congestion
Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806889
Page 139 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806890
Page 140 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806891
Page 141 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806892
Page 142 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806893
Page 143 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806894
Page 144 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806895
Page 145 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806896
Page 146 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806897
Page 147 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806898
Page 148 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806899
Page 149 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806900
Page 150 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806901
Page 151 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806902
Page 152 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806903
Page 153 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806904
Page 154 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806905
Page 155 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806906
Page 156 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806907
Page 157 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806908
Page 158 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806909
Page 159 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806910
Page 160 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806911
Page 161 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806912
Page 162 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806913
Page 163 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806914
Page 164 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806915
Page 165 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806916
Page 166 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806917
Page 167 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806918
Page 168 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806919
Page 169 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806920
Page 170 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806921
Page 171 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:29 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806922
Page 172 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806923
Page 173 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806924
Page 174 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806925
Page 175 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806926
Page 176 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806927
Page 177 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806928
Page 178 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806929
Page 179 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806930
Page 180 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806931
Page 181 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806932
Page 182 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806933
Page 183 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806934
Page 184 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806935
Page 185 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806936
Page 186 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806937
Page 187 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806938
Page 188 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806939
Page 189 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806940
Page 190 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806941
Page 191 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806942
Page 192 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806943
Page 193 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806944
Page 194 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806945
Page 195 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806946
Page 196 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806947
Page 197 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806948
Page 198 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806949
Page 199 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806950
Page 200 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.fOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806951
Page 201 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806952
Page 202 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806953
Page 203 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806954
Page 204 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806955
Page 205 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806956
Page 206 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806957
Page 207 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806958
Page 208 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.hOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806959
Page 209 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806960
Page 210 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806961
Page 211 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806962
Page 212 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.iOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806963
Page 213 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806964
Page 214 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806965
Page 215 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806966
Page 216 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.jOct-13-2020 11:07:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806967
Page 217 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806968
Page 218 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806969
Page 219 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806970
Page 220 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806971
Page 221 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806972
Page 222 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-13-2020 11:09:46 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806973
Page 223 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:10:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806974
Page 224 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:10:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806975
Page 225 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aOct-13-2020 11:10:02 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806976
Page 226 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:10:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806977
Page 227 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:10:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806978
Page 228 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:10:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806979
Page 229 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:10:18 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806980
Page 230 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806981
Page 231 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806982
Page 232 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806983
Page 233 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806984
Page 234 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806985
Page 235 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806986
Page 236 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 11:11:14 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806987
Page 237 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 11:11:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806988
Page 238 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 11:11:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806989
Page 239 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 11:11:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806990
Page 240 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 11:11:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806991
Page 241 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 11:11:34 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806992
Page 242 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806993
Page 243 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806994
Page 244 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806995
Page 245 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806996
Page 246 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806997
Page 247 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806998
Page 248 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0806999
Page 249 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807000
Page 250 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807001
Page 251 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807002
Page 252 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Jan-27-2021 14:37:04 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807003
Page 253 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807004
Page 254 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807005
Page 255 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Jan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807006
Page 256 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Jan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807007
Page 257 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Jan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807008
Page 258 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Jan-27-2021 14:37:19 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807009
Page 259 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-26-2021 14:10:35 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807010
Page 260 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-26-2021 14:10:35 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807011
Page 261 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-26-2021 14:10:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807012
Page 262 of 423
***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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Jan-26-2021 14:10:47 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807013
Page 263 of 423
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-26-2021 14:11:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807014
Page 264 of 423
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormMar-01-2021 12:12:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807015
Page 265 of 423
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Mar-01-2021 12:12:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807016
Page 266 of 423
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Mar-01-2021 12:12:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807017
Page 267 of 423
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Mar-01-2021 12:12:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807018
Page 268 of 423
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
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: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Mar-01-2021 12:12:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0807019
Page 269 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-26-2021 14:08:54 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-08-2020 11:10:08 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-24-2020 12:30:36 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kawsar Talaat Approved Nov-17-2020 14:26:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KawsarTalaat, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-17-2020 09:57:27 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807020
Page 270 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
Kawsar Talaat Approved Oct-16-2020 15:18:34 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KawsarTalaat, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-16-2020 10:27:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kawsar Talaat Approved Oct-15-2020 16:44:33 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KawsarTalaat, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807021
Page 271 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020 09:50:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-26-2020 09:50:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807022
Page 272 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 09:51:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807023
Page 273 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 09:50:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11451042Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 09:50:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1976Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 09:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 09:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 09:51:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERIC
ANInitial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807024
Page 274 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 09:52:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807025
Page 275 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020 09:52:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 09:52:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 09:52:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807026
Page 276 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020 09:53:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Allergic to penici
llin
Start Date: UNK/UNK/1976
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:53:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:53:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic to penicillinInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 09:53:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1976Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 09:53:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-26-2020 09:54:49
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 2Initial Entry
090177e196ae2fe3\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-2021-5683-0807027
Page 277 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) mber:
Medical Hist
ory Term:Allergic to Monosodiu
m glutamate (MSG)
Start Date: UNK/UNK/1996
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic to Monosodium glutamate
(MSG)Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 09:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 09:54:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-26-2020 09:56:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Allergic to sulf
ur
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae2fe3\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-2021-5683-0807028
Page 278 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:56:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:56:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Allergic to sulfurInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020 09:56:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020 09:56:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-26-2020 10:46:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Seasonal Aller
gies
Start Date: Mar/UNK/202
0
Ongoing: YESChanged Information
Aug-26-2020 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Seasonal Aller
giesInitial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807029
Page 279 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: UNK/UNK/20
20
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020 10:46:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 10:46:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Changed Information
Aug-26-2020 10:07:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
25/Aug/2020. Please
review and update as
appropriate.
Aug-26-2020 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020 09:56:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807030
Page 280 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-26-2020 10:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Gestational dia
betes
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/
2011Transcription Error
Aug-26-2020 10:00:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:5
Medical History
Term:Gestational dia
betes
Start Date: UNK/UNK/201
1
Ongoing: NO
End Date:
UNK/UNK/
2015Transcription Error
Aug-26-2020 09:58:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Gestational dia
betes
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2015Initial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807031
Page 281 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Gestational diabetesInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020 10:00:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Transcription Error
Aug-26-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020 10:00:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Transcription Error
Aug-26-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.f
Date Location User Value Reason
Aug-26-2020 09:59:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:MigrainesInitial Entry
090177e196ae2fe3\Final\Final On: 01-Apr-2021 03:55 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0807032
Page 282 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: UNK/UNK/19
97
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020 09:59:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 09:59:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MigrainesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020 09:59:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020 09:59:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-26-2020 10:01:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:Pre-diabetic
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2
015Initial Entry
090177e196ae2fe3\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-2021-5683-0807033
Page 283 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1145 Site Name: (1145) Johns Hopkins School of Medicine
Subject No: 11451042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020 10:01:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocal
…[truncated]