125742 S1 M5 CRF c4591001 1136 11361029

Document text

Page 1 of 432
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981870
Page 2 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981871
Page 3 of 432
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [11361029]
2.Birth Date: /1978
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981872
Page 4 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981873
Page 5 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981874
Page 6 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981875
Page 7 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nasal polyps]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/2007
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pneumonia]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[uterine fibroids]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981876
Page 8 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[epilepsy]
Start Date: UNK/UNK/2002
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraine headaches]
Start Date: UNK/UNK/1991
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[generalized anxiety]
Start Date: UNK/UNK/2015
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/1988
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[laparoscopic hysterectomy]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981877
Page 9 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sinus surgery]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981878
Page 10 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [145.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981879
Page 11 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981880
Page 12 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [59449]
3.Randomization Group: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981881
Page 13 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BP57RX]
5.bSample ID [BP57RY]
5.cSample ID [BP57RZ]
5.dSample ID [BPRSGM]
5.eSample ID [BPRSGN]
5.fSample ID [BPRSGP]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981882
Page 14 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BP57P6]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981883
Page 15 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/20/2020 14:02
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
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981884
Page 16 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981885
Page 17 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981886
Page 18 of 432
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/28/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981887
Page 19 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981888
Page 20 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981889
Page 21 of 432
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981890
Page 22 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57X5]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981891
Page 23 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/11/2020 15:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981892
Page 24 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981893
Page 25 of 432
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981894
Page 26 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location:
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981895
Page 27 of 432
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BM91MZ]
5.bSample ID [BM91N0]
5.cSample ID [BM91N1]
5.dSample ID [BPRSL0]
5.eSample ID [BPRSL1]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981896
Page 28 of 432
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981897
Page 29 of 432
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
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 [BP586T]
5.bSample ID [BP586V]
5.cSample ID [BP586W]
5.dSample ID [BPRSWT]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981898
Page 30 of 432
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981899
Page 31 of 432
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981900
Page 32 of 432
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981901
Page 33 of 432
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981902
Page 34 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981903
Page 35 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom Started: Nov/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/19/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981904
Page 36 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [SINUS CONGESTION]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981905
Page 37 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981906
Page 38 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981907
Page 39 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SUBJECT CAME INTO THE SITE FOR SWAB COLLECTION]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981908
Page 40 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/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 [BRFWTR]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981909
Page 41 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981910
Page 42 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981911
Page 43 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981912
Page 44 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981913
Page 45 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981914
Page 46 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981915
Page 47 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981916
Page 48 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981917
Page 49 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981918
Page 50 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981919
Page 51 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981920
Page 52 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981921
Page 53 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981922
Page 54 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981923
Page 55 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981924
Page 56 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981925
Page 57 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981926
Page 58 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981927
Page 59 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Date: Vital Signs Details Form Instance
 1.Nov/9/2020 Record Identifier: Systolic: Diastolic:
1  112  84 Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981928
Page 60 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [112]
Diastolic: [84]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [72]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981929
Page 61 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Date: Vital Signs Details Form Instance
 1.Nov/9/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981930
Page 62 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/9/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981931
Page 63 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981932
Page 64 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981933
Page 65 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981934
Page 66 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981935
Page 67 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981936
Page 68 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981937
Page 69 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981938
Page 70 of 432
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981939
Page 71 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981940
Page 72 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981941
Page 73 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981942
Page 74 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981943
Page 75 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981944
Page 76 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981945
Page 77 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  worsening of intermittent
seizures Dec/1/2020 0
0:00 NO
End Date Time:
Jan/25/2021 00:00
 Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981946
Page 78 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[worsening of intermittent seizures]
4.Start Date Time: Dec/1/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/25/2021 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Med Hx of epilepsy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981947
Page 79 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981948
Page 80 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981949
Page 81 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981950
Page 82 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981951
Page 83 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981952
Page 84 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981953
Page 85 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981954
Page 86 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981955
Page 87 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981956
Page 88 of 432
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981957
Page 89 of 432
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981958
Page 90 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981959
Page 91 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981960
Page 92 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981961
Page 93 of 432
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981962
Page 94 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981963
Page 95 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981964
Page 96 of 432
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981965
Page 97 of 432
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981966
Page 98 of 432
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981967
Page 99 of 432
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981968
Page 100 of 432
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981969
Page 101 of 432
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981970
Page 102 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981971
Page 103 of 432
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981972
Page 104 of 432
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981973
Page 105 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981974
Page 106 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981975
Page 107 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981976
Page 108 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormAug-20-2020 14:40:45 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981977
Page 109 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormAug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981978
Page 110 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Aug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981979
Page 111 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Aug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981980
Page 112 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Aug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981981
Page 113 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Aug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981982
Page 114 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Aug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981983
Page 115 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aAug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981984
Page 116 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aAug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981985
Page 117 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aAug-20-2020 14:47:09 (UTC-08:00) Pacific
Time (US & Canada)not of child bearing potential
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981986
Page 118 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormSep-18-2020 12:39:04 (UTC-08:00) Pacific
Time (US & Canada)NOCBP
Not Applicable
FormSep-18-2020 12:38:56 (UTC-08:00) Pacific
Time (US & Canada)NOCBP
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981987
Page 119 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Sep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981988
Page 120 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Sep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981989
Page 121 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Sep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981990
Page 122 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Sep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981991
Page 123 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Sep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981992
Page 124 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aSep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981993
Page 125 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aSep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981994
Page 126 of 432
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6.aSep-18-2020 12:39:04 (UTC-08:00) Pacific Time
(US & Canada)NOCBP
Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981995
Page 127 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 13:46:57 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981996
Page 128 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aNov-10-2020 13:49:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981997
Page 129 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.bNov-10-2020 13:49:30 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981998
Page 130 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.cNov-10-2020 13:51:26 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981999
Page 131 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.dNov-10-2020 13:51:35 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982000
Page 132 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.eNov-10-2020 13:51:44 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982001
Page 133 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2 fNov-10-2020 13:51:53 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982002
Page 134 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.gNov-10-2020 13:52:04 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982003
Page 135 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2 hNov-10-2020 13:52:13 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982004
Page 136 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 13:52:22 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982005
Page 137 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 13:52:45 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982006
Page 138 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 13:52:55 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982007
Page 139 of 432
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 13:53:05 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982008
Page 140 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982009
Page 141 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982010
Page 142 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982011
Page 143 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982012
Page 144 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982013
Page 145 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982014
Page 146 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982015
Page 147 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
7Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982016
Page 148 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
8Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982017
Page 149 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
9Nov-10-2020 09:07:35 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982018
Page 150 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982019
Page 151 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982020
Page 152 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982021
Page 153 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
3Nov-12-2020 08:58:50 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
3Nov-10-2020 09:10:26 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982022
Page 154 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982023
Page 155 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
5Nov-12-2020 08:59:08 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
5Nov-10-2020 09:10:53 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982024
Page 156 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6Nov-12-2020 15:57:21 (UTC-08:00) Pacific
Time (US & Canada)Not Done
6Nov-10-2020 09:12:58 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
6Nov-10-2020 09:11:09 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982025
Page 157 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-12-2020 08:58:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982026
Page 158 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-12-2020 08:58:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982027
Page 159 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-12-2020 08:58:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
2Nov-10-2020 09:13:52 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982028
Page 160 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-12-2020 08:58:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982029
Page 161 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-12-2020 08:58:20 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
4Nov-10-2020 09:14:14 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982030
Page 162 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982031
Page 163 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982032
Page 164 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982033
Page 165 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982034
Page 166 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982035
Page 167 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982036
Page 168 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982037
Page 169 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982038
Page 170 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982039
Page 171 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982040
Page 172 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982041
Page 173 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982042
Page 174 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982043
Page 175 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982044
Page 176 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982045
Page 177 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982046
Page 178 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982047
Page 179 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982048
Page 180 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982049
Page 181 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982050
Page 182 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982051
Page 183 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982052
Page 184 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982053
Page 185 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982054
Page 186 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982055
Page 187 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982056
Page 188 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982057
Page 189 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982058
Page 190 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982059
Page 191 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982060
Page 192 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982061
Page 193 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982062
Page 194 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:16:48 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982063
Page 195 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982064
Page 196 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982065
Page 197 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982066
Page 198 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982067
Page 199 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982068
Page 200 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982069
Page 201 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982070
Page 202 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982071
Page 203 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982072
Page 204 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982073
Page 205 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982074
Page 206 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982075
Page 207 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982076
Page 208 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982077
Page 209 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982078
Page 210 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982079
Page 211 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982080
Page 212 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982081
Page 213 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982082
Page 214 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982083
Page 215 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982084
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982085
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982086
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982087
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982088
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982089
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982090
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982091
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 fNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982092
Page 224 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982093
Page 225 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982094
Page 226 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982095
Page 227 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982096
Page 228 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 hNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982097
Page 229 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 hNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982098
Page 230 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 hNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982099
Page 231 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5 hNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982100
Page 232 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982101
Page 233 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982102
Page 234 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982103
Page 235 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982104
Page 236 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982105
Page 237 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982106
Page 238 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982107
Page 239 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:17:07 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982108
Page 240 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:22:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0982109
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:22:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982110
Page 242 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:22:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982111
Page 243 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:22:13 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982112
Page 244 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982113
Page 245 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982114
Page 246 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982115
Page 247 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982116
Page 248 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982117
Page 249 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982118
Page 250 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6Nov-10-2020 09:22:29 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982119
Page 251 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormNov-10-2020 09:22:45 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982120
Page 252 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Nov-10-2020 09:22:45 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982121
Page 253 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Nov-10-2020 09:22:45 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982122
Page 254 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Nov-10-2020 09:22:45 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982123
Page 255 of 432
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Nov-10-2020 09:22:45 (UTC-08:00) Pacific
Time (US & Canada)Not Done
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982124
Page 256 of 432
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-21-2021 12:13:31 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982125
Page 257 of 432
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-21-2021 12:13:31 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982126
Page 258 of 432
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-21-2021 12:13:50 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982127
Page 259 of 432
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-21-2021 12:13:50 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982128
Page 260 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-09-2021 11:42:29 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Levin  Approved Jan-22-2021 12:16:09 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLevin, 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-19-2021 10:20:19 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Levin  Approved Nov-16-2020 13:13:08 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLevin, 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.
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982129
Page 261 of 432
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 14:39:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-20-2020 14:39:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982130
Page 262 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 14:40:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982131
Page 263 of 432
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 14:39:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11361029Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 14:39:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1978Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 14:40:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 14:40:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 14:40:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982132
Page 264 of 432
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 14:40:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982133
Page 265 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 14:41:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 14:41:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 14:41:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982134
Page 266 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 14:41:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:nasal polyps
Start Date: UNK/UNK/201
4
Ongoing: NO
End Date:
UNK/UNK/
2014Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:41:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:41:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
nasal polypsInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-20-2020 14:41:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982135
Page 267 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-20-2020 14:41:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020 14:41:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:asthma
Start Date: UNK/UNK/2
007
Ongoing: YESInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982136
Page 268 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:41:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:41:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
asthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-20-2020 14:41:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020 14:41:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-20-2020 14:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:pneumonia
Start Date: UNK/UNK/200
7
Ongoing: NO
End Date:
UNK/UNK/
2007Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982137
Page 269 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
pneumoniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-20-2020 14:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-20-2020 14:42:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.d
Date Location User Value Reason
Aug-20-2020 14:42:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:uterine fibroids
Start Date: UNK/UNK/201
3Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982138
Page 270 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: NO
End Date:
UNK/UNK/
2013
1.d Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:42:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:42:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
uterine fibroidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-20-2020 14:42:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-20-2020 14:42:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.e
Date Location User Value Reason
Aug-20-2020 14:42:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:epilepsyInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982139
Page 271 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Start Date: UNK/UNK/2
002
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:42:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:42:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
epilepsyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-20-2020 14:42:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-20-2020 14:42:55
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-20-2020 14:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:migraine heada
ches
Start Date: UNK/UNK/19
91Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982140
Page 272 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
migraine headachesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-20-2020 14:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1991Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-20-2020 14:43:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-20-2020 14:43:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:generalized an
xiety
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982141
Page 273 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.g Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:43:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:43:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
generalized anxietyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-20-2020 14:43:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-20-2020 14:43:32
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-20-2020 14:43:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History T
erm:seasonal aller
gies
Start Date: UNK/UNK/1
988
Ongoing: YESInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982142
Page 274 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.h Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:43:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:43:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-20-2020 14:43:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-20-2020 14:43:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-20-2020 14:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:9
Medical Histo
ry Term:laparoscopic hyst
erectomy
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/20
13Transcription Error
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982143
Page 275 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-20-2020 14:44:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histo
ry Term:laproscopic hyste
rectomy
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2
013Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982144
Page 276 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.i Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:44:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
laparoscopic hysterectomyTranscription Error
Aug-20-2020 14:44:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
laproscopic hysterectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-20-2020 14:44:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-20-2020 14:44:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.j
Date Location User Value Reason
Aug-20-2020 14:45:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:sinus surgery
Start Date: UNK/UNK/201
4Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982145
Page 277 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: NO
End Date:
UNK/UNK/
2014
1.j Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:45:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:45:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
sinus surgeryInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982146
Page 278 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.j Start Date:
Date Location User Value Reason
Aug-20-2020 14:45:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-20-2020 14:45:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982147
Page 279 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
145.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.4Initial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0982148
Page 280 of 432
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
7.a
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 14:46:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d89033\Final\Final On: 22-Apr-2021 02:14 (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-2021-5683-0982149
Page 281 of 432
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361029 Subject Initials: ---
Genera
…[truncated]