125742 S1 M5 CRF c4591001 1117 11171058

Document text

Page 1 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793952
Page 2 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793953
Page 3 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171058]
2.Birth Date: 1986
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0793954
Page 4 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793955
Page 5 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793956
Page 6 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793957
Page 7 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793958
Page 8 of 495
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [159.2]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [24.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793959
Page 9 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [64846]
3.Randomization Group: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793960
Page 10 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58L8]
5.bSample ID [BP58L9]
5.cSample ID [BP58LB]
5.dSample ID [BPRTZF]
5.eSample ID [BPRTZG]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793961
Page 11 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58KK]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793962
Page 12 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/25/2020 16:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793963
Page 13 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793964
Page 14 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793965
Page 15 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793966
Page 16 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8YJ9]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793967
Page 17 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 16:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793968
Page 18 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793969
Page 19 of 495
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ8GP]
5.bSample ID [BRJ8GR]
5.cSample ID [BRJ8GS]
5.dSample ID [BRSRM7]
5.eSample ID [BRSRM8]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793970
Page 20 of 495
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793971
Page 21 of 495
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793972
Page 22 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793973
Page 23 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793974
Page 24 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793975
Page 25 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793976
Page 26 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit ERRONEOUS VISIT Comments
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793977
Page 27 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793978
Page 28 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793979
Page 29 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793980
Page 30 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793981
Page 31 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793982
Page 32 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793983
Page 33 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793984
Page 34 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793985
Page 35 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793986
Page 36 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793987
Page 37 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793988
Page 38 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793989
Page 39 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for L
ab TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793990
Page 40 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793991
Page 41 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793992
Page 42 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793993
Page 43 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793994
Page 44 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Applicable  Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable 
Not Applicable  Not D
one Not Appli
cable Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793995
Page 45 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793996
Page 46 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793997
Page 47 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793998
Page 48 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0793999
Page 49 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794000
Page 50 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794001
Page 51 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
1  Not Applicable  Not Applicable Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794002
Page 52 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794003
Page 53 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Done  Not Applicable Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794004
Page 54 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794005
Page 55 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794006
Page 56 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794007
Page 57 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applic
able Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794008
Page 58 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794009
Page 59 of 495
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794010
Page 60 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794011
Page 61 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794012
Page 62 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794013
Page 63 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794014
Page 64 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794015
Page 65 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794016
Page 66 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794017
Page 67 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794018
Page 68 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794019
Page 69 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  SUPRACLAVICULAR LYMP
HADENOPATHY, RIGHT Aug/25/2020
15:42 YES  Repeating
Pages
 2. ADVERSE
EVENT 2  Headache  Aug/27/2020
UNK:UNK NO
End Date Time:
Aug/29/2020 UN
K:UNK
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  Myolgia, neck  Aug/26/2020
UNK:UNK NO
End Date Time:
Aug/28/2020 UN
K:UNK
 Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794020
Page 70 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[SUPRACLAVICULAR LYMPHADENOPATHY, RIGHT]
4.Start Date Time: Aug/25/2020 15:42
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794021
Page 71 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794022
Page 72 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Aug/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/29/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794023
Page 73 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794024
Page 74 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myolgia, neck ]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[postural]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794025
Page 75 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794026
Page 76 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794027
Page 77 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794028
Page 78 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of MedicationStart D
ateForm Instanc
e
 1.1  VACCINATION
S NO  FLU VACCINE  Oct/8/20
20 Repeating
Pages
 2.2  VACCINATION
S NO  Tdap (Tetanus, Diphtheria, P
ertussis) Vaccine Oct/27/2
020 Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794029
Page 79 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[FLU VACCINE]
5.Date: Oct/8/2020
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794030
Page 80 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Tdap (Tetanus, Diphtheria, Pertussis) Vaccine]
5.Date: Oct/27/2020
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794031
Page 81 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794032
Page 82 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794033
Page 83 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794034
Page 84 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794035
Page 85 of 495
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794036
Page 86 of 495
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794037
Page 87 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794038
Page 88 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794039
Page 89 of 495
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794040
Page 90 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794041
Page 91 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794042
Page 92 of 495
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794043
Page 93 of 495
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794044
Page 94 of 495
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794045
Page 95 of 495
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794046
Page 96 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794047
Page 97 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794048
Page 98 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794049
Page 99 of 495
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794050
Page 100 of 495
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794051
Page 101 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794052
Page 102 of 495
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794053
Page 103 of 495
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 15:21:55 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794054
Page 104 of 495
***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: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-28-2020 10:42:29 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794055
Page 105 of 495
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-17-2020 09:30:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794056
Page 106 of 495
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-21-2020 12:08:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794057
Page 107 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:31:04 (UTC-06:00) Central Time
(US & Canada)EVENT IS LIKELY Reactogenicity
2Dec-03-2020 17:30:45 (UTC-06:00) Central Time
(US & Canada)EVENT IS LIKELY Reactogenicity
Not Applicable
2Nov-25-2020 13:13:15 (UTC-06:00) Central Time
(US & Canada)EVENT IS LIKELY Reactogenicity
2Sep-30-2020 13:25:37 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:26:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794058
Page 108 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
FormNov-25-2020 13:11:25 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794059
Page 109 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Dec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
1Nov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794060
Page 110 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
2Nov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794061
Page 111 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
3Nov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794062
Page 112 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.aDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.aDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.aNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794063
Page 113 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.bDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.bDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.bNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794064
Page 114 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.cDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.cDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.cNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794065
Page 115 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.dDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.dDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.dNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794066
Page 116 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.eDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.eDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.eNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794067
Page 117 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 fDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4 fDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4 fNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794068
Page 118 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.gDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.gDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.gNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794069
Page 119 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 hDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4 hDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4 hNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794070
Page 120 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.iDec-03-2020 17:27:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4.iDec-02-2020 14:34:20 (UTC-06:00) Central Time
(US & Canada)
4.iNov-25-2020 13:11:25 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794071
Page 121 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormSep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
FormSep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794072
Page 122 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794073
Page 123 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794074
Page 124 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794075
Page 125 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794076
Page 126 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
5Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794077
Page 127 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
6Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
6Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794078
Page 128 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
7Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
7Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794079
Page 129 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
8Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
8Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794080
Page 130 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Dec-10-2020 10:45:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
9Sep-21-2020 15:36:43 (UTC-06:00) Central Time
(US & Canada)Not Done
9Sep-21-2020 15:30:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794081
Page 131 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-03-2020 17:28:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormDec-02-2020 14:34:00 (UTC-06:00) Central Time
(US & Canada)
FormNov-25-2020 13:08:50 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-24-2020 12:14:51 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:36:57 (UTC-06:00) Central Time
(US & Canada)Not Done
FormSep-21-2020 15:30:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794082
Page 132 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-03-2020 17:28:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Dec-02-2020 14:34:00 (UTC-06:00) Central Time
(US & Canada)
1Nov-25-2020 13:08:50 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-24-2020 12:14:51 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:36:57 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-21-2020 15:30:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794083
Page 133 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:28:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-02-2020 14:34:00 (UTC-06:00) Central Time
(US & Canada)
2Nov-25-2020 13:08:50 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-24-2020 12:14:51 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:36:57 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-21-2020 15:30:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794084
Page 134 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-03-2020 17:28:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-02-2020 14:34:00 (UTC-06:00) Central Time
(US & Canada)
3Nov-25-2020 13:08:50 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-24-2020 12:14:51 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:36:57 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-21-2020 15:30:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794085
Page 135 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-03-2020 17:28:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Dec-02-2020 14:34:00 (UTC-06:00) Central Time
(US & Canada)
4Nov-25-2020 13:08:50 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-25-2020 13:39:11 (UTC-06:00) Central Time
(US & Canada)Not requested by the investigator
4Sep-24-2020 12:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-24-2020 12:14:51 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:36:57 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-21-2020 15:30:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794086
Page 136 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-03-2020 17:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormDec-02-2020 14:33:45 (UTC-06:00) Central Time
(US & Canada)
FormNov-25-2020 13:07:41 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-24-2020 16:32:45 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:37:13 (UTC-06:00) Central Time
(US & Canada)Not Done
FormSep-21-2020 15:30:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794087
Page 137 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-03-2020 17:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Dec-02-2020 14:33:45 (UTC-06:00) Central Time
(US & Canada)
1Nov-25-2020 13:07:41 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-24-2020 16:32:45 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:37:13 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-21-2020 15:30:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794088
Page 138 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-02-2020 14:33:45 (UTC-06:00) Central Time
(US & Canada)
2Nov-25-2020 13:07:41 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-24-2020 16:32:45 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:37:13 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-21-2020 15:30:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794089
Page 139 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-03-2020 17:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-02-2020 14:33:45 (UTC-06:00) Central Time
(US & Canada)
3Nov-25-2020 13:07:41 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-24-2020 16:32:45 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:37:13 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-21-2020 15:30:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794090
Page 140 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-03-2020 17:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Dec-02-2020 14:33:45 (UTC-06:00) Central Time
(US & Canada)
4Nov-25-2020 13:07:41 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-24-2020 16:32:45 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:37:13 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-21-2020 15:30:55 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794091
Page 141 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
FormNov-25-2020 13:06:17 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794092
Page 142 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.aDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1.aDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1.aNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1.aSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1.aSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794093
Page 143 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.bDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1.bDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1.bNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1.bSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1.bSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794094
Page 144 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.cDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1.cDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1.cNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1.cSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1.cSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794095
Page 145 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.dDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1.dDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1.dNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1.dSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1.dSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794096
Page 146 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.eDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1.eDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1.eNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1.eSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1.eSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794097
Page 147 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1 fDec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1 fDec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
1 fNov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
1 fSep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
1 fSep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794098
Page 148 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
2Nov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794099
Page 149 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-03-2020 17:27:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-02-2020 14:31:41 (UTC-06:00) Central Time
(US & Canada)
3Nov-25-2020 13:06:17 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-24-2020 16:31:54 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:31:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794100
Page 150 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormNov-25-2020 13:04:39 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormOct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794101
Page 151 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794102
Page 152 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794103
Page 153 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794104
Page 154 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794105
Page 155 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
5Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
5Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794106
Page 156 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-10-2020 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
6Nov-25-2020 13:04:39 (UTC-06:00) Central Time
(US & Canada)Not Done
6Oct-22-2020 17:24:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
6Oct-19-2020 18:01:27 (UTC-06:00) Central Time
(US & Canada)
6Sep-21-2020 15:32:20 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794107
Page 157 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-03-2020 17:27:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormDec-02-2020 14:30:28 (UTC-06:00) Central Time
(US & Canada)
FormNov-25-2020 13:04:23 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794108
Page 158 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-03-2020 17:27:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Dec-02-2020 14:30:28 (UTC-06:00) Central Time
(US & Canada)
1Nov-25-2020 13:04:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794109
Page 159 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-03-2020 17:27:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-02-2020 14:30:28 (UTC-06:00) Central Time
(US & Canada)
2Nov-25-2020 13:04:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794110
Page 160 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-03-2020 17:27:42 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-02-2020 14:30:28 (UTC-06:00) Central Time
(US & Canada)
3Nov-25-2020 13:04:23 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794111
Page 161 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-10-2020 10:54:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormNov-25-2020 13:03:42 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-22-2020 17:25:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormOct-19-2020 18:01:47 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:33:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794112
Page 162 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-10-2020 10:54:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Nov-25-2020 13:03:42 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-22-2020 17:25:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-19-2020 18:01:47 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:33:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794113
Page 163 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-10-2020 10:54:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Nov-25-2020 13:03:42 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-22-2020 17:25:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-19-2020 18:01:47 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:33:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794114
Page 164 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-10-2020 10:54:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-25-2020 13:03:42 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-22-2020 17:25:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-19-2020 18:01:47 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:33:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794115
Page 165 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-10-2020 10:54:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Nov-25-2020 13:03:42 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-22-2020 17:25:26 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-19-2020 18:01:47 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:33:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794116
Page 166 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormNov-25-2020 13:03:24 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
FormSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794117
Page 167 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Nov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
1Sep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794118
Page 168 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Nov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
2Sep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794119
Page 169 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
3Sep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794120
Page 170 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Nov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
4Sep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794121
Page 171 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794122
Page 172 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794123
Page 173 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794124
Page 174 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794125
Page 175 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794126
Page 176 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794127
Page 177 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794128
Page 178 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794129
Page 179 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794130
Page 180 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794131
Page 181 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794132
Page 182 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794133
Page 183 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794134
Page 184 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794135
Page 185 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794136
Page 186 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794137
Page 187 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794138
Page 188 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794139
Page 189 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794140
Page 190 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794141
Page 191 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794142
Page 192 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794143
Page 193 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794144
Page 194 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794145
Page 195 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794146
Page 196 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794147
Page 197 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794148
Page 198 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:54:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:24 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:06 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:38:07 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gSep-21-2020 15:33:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794149
Page 199 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormNov-25-2020 13:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
FormSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794150
Page 200 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Nov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
1Sep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794151
Page 201 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Nov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
2Sep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794152
Page 202 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
3Sep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794153
Page 203 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Nov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
4Sep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794154
Page 204 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794155
Page 205 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794156
Page 206 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794157
Page 207 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.aOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.aSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794158
Page 208 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794159
Page 209 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794160
Page 210 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794161
Page 211 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.bOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.bSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794162
Page 212 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794163
Page 213 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794164
Page 214 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794165
Page 215 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.cOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.cSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794166
Page 216 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794167
Page 217 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794168
Page 218 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794169
Page 219 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.dOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.dSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794170
Page 220 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794171
Page 221 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794172
Page 222 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794173
Page 223 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.eOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.eSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794174
Page 224 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794175
Page 225 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794176
Page 226 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794177
Page 227 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 fOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 fSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794178
Page 228 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794179
Page 229 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794180
Page 230 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794181
Page 231 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5.gOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5.gSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794182
Page 232 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 hOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 hSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794183
Page 233 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 hOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 hSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794184
Page 234 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 hOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 hSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794185
Page 235 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hNov-25-2020 13:03:08 (UTC-06:00) Central Time
(US & Canada)Not Done
5 hOct-22-2020 17:26:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
5 hOct-19-2020 18:02:29 (UTC-06:00) Central Time
(US & Canada)
5 hSep-21-2020 15:33:56 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3dc8\Final\Final On: 01-Apr-2021 04:41 (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-2021-5683-0794186
Page 236 of 495
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171058 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iDec-10-2020 10:55:08 (UTC-06:00) Central Time
(US & Canada)Not Applic
…[truncated]