125742 S1 M5 CRF c4591001 1030 10301110

Document text

Page 1 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903494
Page 2 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/18/2020
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903495
Page 3 of 366
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10301110]
2.Birth Date: 1970
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903496
Page 4 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903497
Page 5 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903498
Page 6 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903499
Page 7 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903500
Page 8 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [58.0]
3.Unit: kg
4.Height: [162.56]
5.Unit: cm
6.Body Mass Index: [21.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903501
Page 9 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
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:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903502
Page 10 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [92835]
3.Randomization Group: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903503
Page 11 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP16L8]
5.bSample ID [BPHPNL]
5.cSample ID [BPHPNM]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903504
Page 12 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP16L7]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903505
Page 13 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/18/2020 13:40
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903506
Page 14 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903507
Page 15 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903508
Page 16 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903509
Page 17 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/9/2020
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:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903510
Page 18 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
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 [BR2N81]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903511
Page 19 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Oct/9/2020 09:05
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903512
Page 20 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903513
Page 21 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BP1676]
5.bSample ID [BSHZC3]
5.cSample ID [BSHZC4]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903514
Page 22 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903515
Page 23 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/7/2021
2.Date of First Symptom Started: Jan/6/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/12/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903516
Page 24 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Col
lectionSpecimen TypeSpecimen Collectio
n LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/7/2021  SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903517
Page 25 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/7/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903518
Page 26 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW84460]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903519
Page 27 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[A SELF SWAP WAS DONE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903520
Page 28 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903521
Page 29 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applicable
 Not Applicable
 Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903522
Page 30 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903523
Page 31 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Jan/7/2021
3.Toxicity Grade: 1
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903524
Page 32 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903525
Page 33 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903526
Page 34 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applica
ble Not Applicab
le Not Applica
ble Sponsor-Defined Ide
ntifierTest: Result:
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble 
Not Applicable  Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903527
Page 35 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903528
Page 36 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903529
Page 37 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903530
Page 38 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903531
Page 39 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  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 
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903532
Page 40 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903533
Page 41 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903534
Page 42 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903535
Page 43 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903536
Page 44 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903537
Page 45 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903538
Page 46 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903539
Page 47 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903540
Page 48 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903541
Page 49 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903542
Page 50 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903543
Page 51 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903544
Page 52 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903545
Page 53 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903546
Page 54 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903547
Page 55 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903548
Page 56 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Feb/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903549
Page 57 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[subject's convalescent visit overlapped with her vaccination 3 visits]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8V06]
5.bSample ID [BS7D5V]
5.cSample ID [BS7D5W]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903550
Page 58 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903551
Page 59 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903552
Page 60 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903553
Page 61 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903554
Page 62 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  pharyngitis streptococ
cal Jan/17/2021 UNK:U
NK NO
End Date Time:
Jan/30/2021 UNK:UNK
 Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903555
Page 63 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[pharyngitis streptococcal]
4.Start Date Time: Jan/17/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/30/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).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:
[Bacterial Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903556
Page 64 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021086858]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903557
Page 65 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
 1.          Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903558
Page 66 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903559
Page 67 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903560
Page 68 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.Date: //
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903561
Page 69 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903562
Page 70 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903563
Page 71 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903564
Page 72 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903565
Page 73 of 366
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903566
Page 74 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903567
Page 75 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903568
Page 76 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903569
Page 77 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903570
Page 78 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903571
Page 79 of 366
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903572
Page 80 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903573
Page 81 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903574
Page 82 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903575
Page 83 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903576
Page 84 of 366
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903577
Page 85 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903578
Page 86 of 366
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903579
Page 87 of 366
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903580
Page 88 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903581
Page 89 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/12/2021
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903582
Page 90 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903583
Page 91 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/12/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903584
Page 92 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/12/2021
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:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903585
Page 93 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[subject's convalescent visit overlapped with her vaccination 3 visits]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903586
Page 94 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BR8V0D]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903587
Page 95 of 366
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/12/2021 13:55
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903588
Page 96 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903589
Page 97 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/4/2021
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:
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903590
Page 98 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/4/2021
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 [BR8V10]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903591
Page 99 of 366
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Mar/4/2021 09:20
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903592
Page 100 of 366
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903593
Page 101 of 366
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903594
Page 102 of 366
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903595
Page 103 of 366
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903596
Page 104 of 366
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903597
Page 105 of 366
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903598
Page 106 of 366
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903599
Page 107 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903600
Page 108 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903601
Page 109 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903602
Page 110 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 13:02:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903603
Page 111 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 13:04:39 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903604
Page 112 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903605
Page 113 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903606
Page 114 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903607
Page 115 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903608
Page 116 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903609
Page 117 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903610
Page 118 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-07-2021 16:58:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903611
Page 119 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-12-2021 21:55:46 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903612
Page 120 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-12-2021 21:55:46 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903613
Page 121 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-12-2021 21:55:46 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903614
Page 122 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-12-2021 21:55:46 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903615
Page 123 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-12-2021 21:55:46 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
FormJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
1Jan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
2Jan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
3Jan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
4Jan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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ItemDate User Comment
5.aJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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(b) (4)
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Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
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090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:36 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903649
Page 157 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903650
Page 158 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903651
Page 159 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903652
Page 160 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903653
Page 161 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903654
Page 162 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903655
Page 163 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903656
Page 164 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903657
Page 165 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903658
Page 166 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903659
Page 167 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903660
Page 168 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903661
Page 169 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903662
Page 170 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903663
Page 171 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903664
Page 172 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903665
Page 173 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903666
Page 174 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903667
Page 175 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903668
Page 176 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903669
Page 177 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903670
Page 178 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903671
Page 179 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903672
Page 180 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903673
Page 181 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903674
Page 182 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903675
Page 183 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903676
Page 184 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903677
Page 185 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903678
Page 186 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903679
Page 187 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903680
Page 188 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.gJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903686
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903689
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903691
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903692
Page 200 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903693
Page 201 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-07-2021 17:00:57 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903694
Page 202 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - COVID - Comments
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903695
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903696
Page 204 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903697
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903698
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903699
Page 207 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-07-2021 17:01:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903700
Page 208 of 366
***Confidential***
Header Text: c4591001
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Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-07-2021 17:01:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903701
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-07-2021 17:01:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903702
Page 210 of 366
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aJan-07-2021 17:01:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0903703
Page 211 of 366
***Confidential***
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Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-07-2021 17:02:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903704
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-07-2021 17:02:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903705
Page 213 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
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Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-07-2021 17:02:08 (UTC-05:00) Eastern Time (US
& Canada) )Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903706
Page 214 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-07-2021 17:02:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903707
Page 215 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903708
Page 216 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903709
Page 217 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903710
Page 218 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903711
Page 219 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903712
Page 220 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903713
Page 221 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-12-2021 21:56:07 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903714
Page 222 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-12-2021 21:56:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903715
Page 223 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-12-2021 21:56:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903716
Page 224 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-12-2021 21:56:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903717
Page 225 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-12-2021 21:56:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903718
Page 226 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-12-2021 21:56:26 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903719
Page 227 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-12-2021 19:39:40 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903720
Page 228 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 Feb-02-2021 15:18:16 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Salata  Approved Jan-26-2021 12:52:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertSalata, 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 Jan-07-2021 16:49:14 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Salata  Approved Nov-13-2020 16:04:26 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertSalata, 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.
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903721
Page 229 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-18-2020 13:01:11
(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
Sep-18-2020 13:01:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903722
Page 230 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020 13:01:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/18/2020Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903723
Page 231 of 366
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020 13:00:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10301110Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020 13:00:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020 13:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-18-2020 13:01:56
(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
Sep-18-2020 13:01:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903724
Page 232 of 366
***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: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 13:02:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903725
Page 233 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020 13:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 13:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 13:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903726
Page 234 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
58.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020 13:07:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
162.56Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020 13:07:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.9Initial Entry
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
7.a
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (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-2021-5683-0903727
Page 235 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Location
::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 13:07:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (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-2021-5683-0903728
Page 236 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903729
Page 237 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 13:08:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903730
Page 238 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020 19:59:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020 19:59:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
92835Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903731
Page 239 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 19:46:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 13:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-18-2020 13:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-18-2020 13:29:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 19:46:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP16L8Initial Entry
5.a Sample ID
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903732
Page 240 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020 19:46:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP16L8Initial Entry
5.b
Date Location User Value Reason
Sep-18-2020 19:46:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHPNLInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020 19:46:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHPNLInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020 19:47:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHPNMInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020 19:47:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHPNMInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0903733
Page 241 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:30:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:30:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 19:48:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 13:37:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-18-2020 13:30:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-18-2020 13:30:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 19:48:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP16L7Initial Entry
5.a Sample ID
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903734
Page 242 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020 19:48:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP16L7Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903735
Page 243 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 13:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 19:58:04 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903736
Page 244 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-18-2020 19:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903737
Page 245 of 366
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-18-2020 13:09:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903738
Page 246 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020 18:12:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903739
Page 247 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Location
::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-09-2020 18:14:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903740
Page 248 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903741
Page 249 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-09-2020 18:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903742
Page 250 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 18:15:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 18:15:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 09:04:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-10-2020 05:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-09-2020 18:15:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-09-2020 18:15:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 09:04:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2N81Initial Entry
5.a Sample ID
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903743
Page 251 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-12-2020 09:04:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR2N81Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903744
Page 252 of 366
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020 09:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-09-2020 18:13:30 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903745
Page 253 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-09-2020 18:13:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903746
Page 254 of 366
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 11:45:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903747
Page 255 of 366
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 11:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 11:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 19:16:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 11:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-06-2020 11:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 19:16:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1676Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 19:16:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1676Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903748
Page 256 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b
Date Location User Value Reason
Nov-06-2020 19:16:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHZC3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 19:16:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSHZC3Initial Entry
5.c
Date Location User Value Reason
Nov-06-2020 19:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHZC4Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 19:16:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSHZC4Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903749
Page 257 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021 14:39:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Closed Response satisfies
query
Feb-17-2021 00:38:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Closed Closed, CONVA visit
added
Feb-16-2021 22:08:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered Changed data per query
Feb-15-2021 21:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Answered Completed
Feb-12-2021 05:08:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Opened PDQ: Convalescent
visit is missing and 35+
days (36) have passed
since COVID Illness
Visit. If visit occurred
record data as a
matching CONVA
visit; if visit did not
occur attempt to
schedule visit even if
OOW and obtain the
CONVA sample else
clarify.
Feb-09-2021 08:46:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Reissued:Opened Clin: Please keep query
open until resolution
Feb-09-2021 07:19:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered still waiting on
information, will
update when it comes
in
Feb-02-2021 14:33:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Reissued:Opened Clin: Please keep query
open until resolution
Feb-01-2021 18:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered waiting for information
Feb-01-2021 10:48:01
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Salim
BouguermouhQuery 4: Opened Clin: It was stated in
the SAE report
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0903750
Page 258 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) #2021086858 that the
subject was
hospitalized. Please
obtain subject medical
records and update as
appropriate the CRF
forms (COVID TEST,
ILL SEVERE, LAB
CHEM/HME, VITAL
COV, PULSE OX,
OXYGEN,
VASOPRESS,
IMAGING)
Jan-19-2021 03:51:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Data updated
Jan-12-2021 00:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate Please review this
query once data is
entered on ILL POTEN
form.
Jan-08-2021 14:16:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answered waiting on more
information about the
visit from coordinators
to complete case report
forms. thanks
Jan-08-2021 07:41:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review and
complete ‘Illness
Details form' at this
visit. Thank you.
Jan-07-2021 16:56:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-07-2021 16:49:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Jan-07-2021 16:49:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0903751
Page 259 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
missing. Please review
and update as
appropriate.
Jan-07-2021 16:49:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-07-2021 16:49:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903752
Page 260 of 366
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-18-2021 14:35:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-16-2021 21:51:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Feb-15-2021 22:19:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Please Date of
Assessment 7Jan2021
cannot be before the
symptoms start date
17Jan2021
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-17-2021 10:24:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-16-2021 21:47:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-16-2021 21:47:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Transcription Error
Feb-16-2021 20:46:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Data is discrepant. Per
source, symptoms
started on 06-Jan-2021.
Please review and
reconcile.
Feb-15-2021 21:27:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/17/2021Transcription Error
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0903753
Page 261 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-18-2021 14:36:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-17-2021 11:12:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-17-2021 11:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-16-2021 21:48:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Feb-16-2021 21:48:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-16-2021 21:48:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-16-2021 21:48:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Jan/12/2021Transcription Error
Feb-16-2021 20:48:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened Please review source
and consider adding
other symptom of
"fatigue".
Feb-16-2021 20:47:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Data is discrepant.
Please add new
information clarifying
stop date, as noted in
source on 12-Jan-2021.
Feb-09-2021 08:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Please keep query
open until resolution
Feb-09-2021 07:18:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered still waiting on
information, will
update when it comes
in
Feb-02-2021 14:34:18
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Please keep query
open until resolution
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0903754
Page 262 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Feb-01-2021 18:47:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered waiting for this
information
Feb-01-2021 10:51:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2021086858 that the
subject experienced
STREP THROAT on
19Jan2021. Please
confirm that at least
one symptom was
ongoing at the time the
STREP THROAT was
diagnosed
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGHInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0903755
Page 263 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptom Pre
sent:YES
4.b Symptoms:
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASED SH
ORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
090177e196ae3f14\Final\Final On: 01-Apr-2021 05:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0903756
Page 264 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1030 Site Name: (1030) University Hospital of Cleveland
Subject No: 10301110 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Jan-07-2021 16:53:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-07-
…[truncated]