125742 S1 M5 CRF c4591001 1117 11171086

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

501

Download PDF ↗ Live URL (may be dead)

Document text

Page 1 of 501
***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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794597
Page 2 of 501
***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: 11171086 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
Sep/3/2020
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794598
Page 3 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171086]
2.Birth Date: /1947
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:
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794599
Page 4 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794600
Page 5 of 501
***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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794601
Page 6 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794602
Page 7 of 501
***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: 11171086 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:[AORTIC ANEURYSM]
Start Date: Dec/UNK/2017
Ongoing: NO
End Date:
Dec/19/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC OBSTRUCTIVE PULMONARY DISEASE]
Start Date: Dec/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY BYPASS GRAFTING]
Start Date: Dec/19/2017
Ongoing: NO
End Date:
Dec/19/2017
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794603
Page 8 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INSERTION]
Start Date: Dec/UNK/2018
Ongoing: NO
End Date:
Dec/UNK/2018
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOCARDIAL INFARCTION ]
Start Date: Dec/UNK/2018
Ongoing: NO
End Date:
Dec/UNK/2018
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CIGARETTE SMOKER]
Start Date: UNK/UNK/1960
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIGH CHOLESTEROL]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794604
Page 9 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CRACK COCAINE USE]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
Dec/UNK/2019
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MARIJUANA USE]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
Dec/UNK/2018
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHOLECYSTECTOMY]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHOLELITHIASIS]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794605
Page 10 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BASAL CELL CARCINOMA FOREHEAD]
Start Date: Jul/13/2020
Ongoing: NO
End Date:
Jul/13/2020
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BASAL CELL CARCINOMA FOREHEAD REMOVAL]
Start Date: Jul/13/2020
Ongoing: NO
End Date:
Jul/13/2020
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL VISION IMPAIRMENT]
Start Date: UNK/UNK/2010
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEPATITIS C]
Start Date: UNK/UNK/1987
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794606
Page 11 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DILAUDID ALLERGY]
Start Date: UNK/UNK/2010
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST TRAUMATIC STRESS SYNDROME]
Start Date: UNK/UNK/2012
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HARVONI TREATMENT ]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.tLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PERIPHERAL OPACITY OF CORNEA]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794607
Page 12 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IMPAIRED GLUCOSE TOLERANCE]
Start Date: UNK/UNK/2017
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PULMONARY HYPERTENSION]
Start Date: UNK/UNK/2010
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN PROSTATE HYPERPLASIA]
Start Date: UNK/UNK/2018
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[EPITHELIAL BASEMENT MEMBRANE DYSTROPHY]
Start Date: UNK/UNK/2018
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CONGESTIVE HEART FAILURE]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794608
Page 13 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CAROTID SUBCLAVIAN TRANSPOSITION, LEFT]
Start Date: Dec/18/2017
Ongoing: NO
End Date:
Dec/18/2017
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[AORTIC ARCH RECONSTRUCTION]
Start Date: Dec/19/2017
Ongoing: NO
End Date:
Dec/19/2017
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEADACHES]
Start Date: Feb/UNK/2020
Ongoing: YES
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIA, INGUINAL, RIGHT]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794609
Page 14 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HERNIA REPAIR, INGUINAL, RIGHT]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HOARSE VOICE]
Start Date: Dec/20/2017
Ongoing: YES
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INSOMNIA]
Start Date: UNK/UNK/2019
Ongoing: YES
1.ahLine/MH Number: [34]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DYSPHAGIA]
Start Date: Dec/20/2017
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794610
Page 15 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.aiLine/MH Number: [35]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PNEUMONIA]
Start Date: Mar/28/2019
Ongoing: NO
End Date:
Apr/UNK/2019
1.ajLine/MH Number: [36]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACUTE HEART FAILURE]
Start Date: Mar/28/2019
Ongoing: NO
End Date:
Apr/UNK/2019
1.akLine/MH Number: [37]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIVERTICULOSIS]
Start Date: Feb/UNK/2016
Ongoing: YES
1.alLine/MH Number: [38]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEMORRHOIDS, INTERNAL]
Start Date: Feb/UNK/2016
Ongoing: YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794611
Page 16 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.amLine/MH Number: [39]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FRACTURE, ORBITAL, LEFT]
Start Date: Mar/UNK/2018
Ongoing: NO
End Date:
Jun/UNK/2018
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794612
Page 17 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [117.8]
3.Unit: LB
4.Height: [65.2]
5.Unit: in
6.Body Mass Index: [19.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794613
Page 18 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [244989]
3.Randomization Group: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794614
Page 19 of 501
***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: 11171086 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:
Sep/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8YCB]
5.bSample ID [BM8YCC]
5.cSample ID [BM8YCV]
5.dSample ID [BPRV15]
5.eSample ID [BPRV16]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794615
Page 20 of 501
***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: 11171086 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/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP58P0]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794616
Page 21 of 501
***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: 11171086 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/3/2020 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794617
Page 22 of 501
***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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794618
Page 23 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794619
Page 24 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794620
Page 25 of 501
***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: 11171086 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/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8YMP]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794621
Page 26 of 501
***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: 11171086 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/22/2020 11:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794622
Page 27 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794623
Page 28 of 501
***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: 11171086 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/21/2020
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 [BRSRPN]
5.bSample ID [BRSRPP]
5.cSample ID [BP58WT]
5.dSample ID [BP58WV]
5.eSample ID [BP58WW]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794624
Page 29 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794625
Page 30 of 501
***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: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794626
Page 31 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794627
Page 32 of 501
***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: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794628
Page 33 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794629
Page 34 of 501
***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: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794630
Page 35 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794631
Page 36 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
//Comments
2.Date of First Symptom Started: Not Done
//Comments
3.Symptoms Ongoing? Not Done Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Done Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Done Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Done Comments
4.dSymptoms: CHILLS
Was symptom present? Not Done Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Done Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794632
Page 37 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Done Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Done Comments
4.iSymptoms: VOMITING
Was symptom present? Not Done Comments
Symptoms - Other
5.aSymptoms - Other Text: Not Done
[ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794633
Page 38 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794634
Page 39 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794635
Page 40 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Sep/14/2020Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[SELF SWAB TAKEN WITHOUT ILLNESS] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV19066]
5.bSample ID Not Applicable
[ ]Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794636
Page 41 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794637
Page 42 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Done Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Done Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Done Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Done Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Done Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Done
[ ]Comments
Health Care Utilization
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794638
Page 43 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794639
Page 44 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794640
Page 45 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794641
Page 46 of 501
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794642
Page 47 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794643
Page 48 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794644
Page 49 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794645
Page 50 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794646
Page 51 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794647
Page 52 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794648
Page 53 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794649
Page 54 of 501
***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: 11171086 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 Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794650
Page 55 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794651
Page 56 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794652
Page 57 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794653
Page 58 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794654
Page 59 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794655
Page 60 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794656
Page 61 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794657
Page 62 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794658
Page 63 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794659
Page 64 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794660
Page 65 of 501
***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: 11171086 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 Done  Not Done  Not Done  Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794661
Page 66 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794662
Page 67 of 501
***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: 11171086 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
cationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794663
Page 68 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794664
Page 69 of 501
***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: 11171086 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 Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794665
Page 70 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794666
Page 71 of 501
***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: 11171086 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:
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794667
Page 72 of 501
***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: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794668
Page 73 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794669
Page 74 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794670
Page 75 of 501
***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: 11171086 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794671
Page 76 of 501
***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: 11171086 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: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794672
Page 77 of 501
***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: 11171086 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:
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794673
Page 78 of 501
***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: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794674
Page 79 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  EXACERBATION O
F COPD Feb/14/2021 UNK
:UNK YES  Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794675
Page 80 of 501
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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)[EXACERBATION OF COPD]
4.Start Date Time: Feb/14/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794676
Page 81 of 501
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[MEDICAL HISTORY OF COPD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021178960]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794677
Page 82 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794678
Page 83 of 501
***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: 11171086 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[ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794679
Page 84 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart DateForm Instan
ce
 1. DELETED 1  VACCINATIO
NS NO  Harvoni Trea
tment UNK/UN
K/2020 Repeating
Pages
 2. 2  VACCINATIO
NS NO  FLU VACCI
NE Oct/14/20
20 Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794680
Page 85 of 501
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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
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).[Harvoni Treatment ]
5.Date: UNK/UNK/2020
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794681
Page 86 of 501
***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: 11171086 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).[FLU VACCINE]
5.Date: Oct/14/2020
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794682
Page 87 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794683
Page 88 of 501
***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: 11171086 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?
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794684
Page 89 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794685
Page 90 of 501
***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: 11171086 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?
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794686
Page 91 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794687
Page 92 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794688
Page 93 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794689
Page 94 of 501
***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: 11171086 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:
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794690
Page 95 of 501
***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: 11171086 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?
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794691
Page 96 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794692
Page 97 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794693
Page 98 of 501
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794694
Page 99 of 501
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794695
Page 100 of 501
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794696
Page 101 of 501
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 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 [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794697
Page 102 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794698
Page 103 of 501
***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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794699
Page 104 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794700
Page 105 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794701
Page 106 of 501
***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: 11171086 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: [ ]
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794702
Page 107 of 501
***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: 11171086 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/21/2020
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794703
Page 108 of 501
***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: 11171086 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
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0794704
Page 109 of 501
***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: 11171086 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 12:12:40 (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.
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794705
Page 110 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-04-2020 19:46:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794706
Page 111 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-12-2020 20:27:16 (UTC-06:00) Central
Time (US & Canada)
2Sep-25-2020 14:33:24 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794707
Page 112 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-05-2020 15:29:20 (UTC-06:00) Central
Time (US & Canada)
4Sep-29-2020 16:46:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794708
Page 113 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
FormOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
FormOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794709
Page 114 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
1Oct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Oct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
1Oct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Oct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
1Oct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794710
Page 115 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
2Oct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
2Oct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
2Oct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794711
Page 116 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
3Oct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
3Oct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
3Oct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794712
Page 117 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.aNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.aOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.aOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.aOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.aOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.aOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.aOct-05-2020 15:22:54 (UTC-06:00) Central
Time (US & Canada)
4.aSep-30-2020 14:19:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794713
Page 118 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.bNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.bOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.bOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.bOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.bOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.bOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.bOct-05-2020 15:12:02 (UTC-06:00) Central
Time (US & Canada)
4.bSep-30-2020 14:19:20 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794714
Page 119 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.cNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.cOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.cOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.cOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.cOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.cOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.cOct-05-2020 15:11:47 (UTC-06:00) Central
Time (US & Canada)
4.cSep-30-2020 14:19:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794715
Page 120 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.dNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.dOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.dOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.dOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.dOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.dOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.dOct-05-2020 15:11:32 (UTC-06:00) Central
Time (US & Canada)
4.dSep-30-2020 14:19:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794716
Page 121 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.eNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.eOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.eOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.eOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.eOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.eOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.eOct-05-2020 15:11:16 (UTC-06:00) Central
Time (US & Canada)
4.eSep-30-2020 14:19:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794717
Page 122 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 fNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4 fOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 fOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4 fOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 fOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4 fOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 fOct-05-2020 15:10:14 (UTC-06:00) Central
Time (US & Canada)
4 fSep-30-2020 14:19:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794718
Page 123 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.gNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.gOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.gOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.gOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.gOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.gOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.gOct-05-2020 15:09:52 (UTC-06:00) Central
Time (US & Canada)
4.gSep-30-2020 14:20:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794719
Page 124 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4 hNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4 hOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 hOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4 hOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 hOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4 hOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 hOct-05-2020 15:10:53 (UTC-06:00) Central
Time (US & Canada)
4 hSep-30-2020 14:20:13 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794720
Page 125 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4.iNov-16-2020 16:19:21 (UTC-06:00) Central
Time (US & Canada)Not Done
4.iOct-27-2020 19:25:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.iOct-27-2020 19:16:03 (UTC-06:00) Central
Time (US & Canada)
4.iOct-17-2020 18:20:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.iOct-12-2020 14:00:04 (UTC-06:00) Central
Time (US & Canada)
4.iOct-06-2020 17:43:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.iOct-05-2020 15:10:37 (UTC-06:00) Central
Time (US & Canada)
4.iSep-30-2020 14:20:26 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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-2021-5683-0794721
Page 126 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794722
Page 127 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
1Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794723
Page 128 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
2Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794724
Page 129 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
3Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794725
Page 130 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
4Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794726
Page 131 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
5Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794727
Page 132 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
6Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794728
Page 133 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
7Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794729
Page 134 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
8Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794730
Page 135 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Dec-15-2020 11:12:15 (UTC-06:00) Central
Time (US & Canada)Not Done
9Oct-17-2020 18:20:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794731
Page 136 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormMar-04-2021 11:44:09 (UTC-06:00) Central
Time (US & Canada)
FormFeb-22-2021 17:56:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794732
Page 137 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Mar-04-2021 11:44:09 (UTC-06:00) Central
Time (US & Canada)
1Feb-22-2021 17:56:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794733
Page 138 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Mar-04-2021 11:44:09 (UTC-06:00) Central
Time (US & Canada)
2Feb-22-2021 17:56:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794734
Page 139 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Mar-04-2021 11:44:09 (UTC-06:00) Central
Time (US & Canada)
3Feb-22-2021 17:56:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Nov-07-2020 21:07:03 (UTC-06:00) Central
Time (US & Canada)SUBJECT COLLECTED THE SELF
COLLECTION KIT IN ERROR.
PARTICIPANT WAS REEDUCATED AND
PROVIDED AN ADDITIONAL KIT.
090177e196ae3dc7\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-2021-5683-0794735
Page 140 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Mar-04-2021 11:44:09 (UTC-06:00) Central
Time (US & Canada)
4Feb-22-2021 17:56:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794736
Page 141 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bMar-04-2021 13:28:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
5.bDec-15-2020 10:28:16 (UTC-06:00) Central
Time (US & Canada)SELF SWAB TAKEN WITHOUT ILLNESS
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794737
Page 142 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-15-2020 10:47:39 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-17-2020 18:20:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794738
Page 143 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-15-2020 10:47:39 (UTC-06:00) Central
Time (US & Canada)Not Done
1Oct-17-2020 18:20:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794739
Page 144 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-15-2020 10:47:39 (UTC-06:00) Central
Time (US & Canada)Not Done
2Oct-17-2020 18:20:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794740
Page 145 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-15-2020 10:47:39 (UTC-06:00) Central
Time (US & Canada)Not Done
3Oct-17-2020 18:20:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794741
Page 146 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-15-2020 10:47:39 (UTC-06:00) Central
Time (US & Canada)Not Done
4Oct-17-2020 18:20:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794742
Page 147 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
FormOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
FormOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794743
Page 148 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.aDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1.aOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.aOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1.aOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.aOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1.aOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794744
Page 149 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.bDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1.bOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.bOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1.bOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.bOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1.bOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794745
Page 150 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.cDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1.cOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.cOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1.cOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.cOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1.cOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794746
Page 151 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.dDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1.dOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.dOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1.dOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.dOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1.dOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794747
Page 152 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1.eDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1.eOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.eOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1.eOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1.eOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1.eOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794748
Page 153 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1 fDec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
1 fOct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1 fOct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
1 fOct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1 fOct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
1 fOct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794749
Page 154 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
2Oct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
2Oct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
2Oct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794750
Page 155 of 501
***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
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-15-2020 10:47:10 (UTC-06:00) Central
Time (US & Canada)Not Done
3Oct-17-2020 18:21:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-12-2020 13:59:40 (UTC-06:00) Central
Time (US & Canada)
3Oct-06-2020 17:44:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-05-2020 15:27:12 (UTC-06:00) Central
Time (US & Canada)
3Oct-02-2020 09:36:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794751
Page 156 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794752
Page 157 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794753
Page 158 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794754
Page 159 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794755
Page 160 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794756
Page 161 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794757
Page 162 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-16-2020 20:20:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794758
Page 163 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-27-2020 19:27:09 (UTC-06:00) Central
Time (US & Canada)
FormOct-17-2020 18:21:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-12-2020 13:59:16 (UTC-06:00) Central
Time (US & Canada)
FormOct-06-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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)
FDA-CBER-2021-5683-0794759
Page 164 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-27-2020 19:27:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Oct-27-2020 19:27:09 (UTC-06:00) Central
Time (US & Canada)
1Oct-17-2020 18:21:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Oct-12-2020 13:59:16 (UTC-06:00) Central
Time (US & Canada)
1Oct-06-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3dc7\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-2021-5683-0794760
Page 165 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-27-2020 19:28:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-27-2020 19:27:09 (UTC-06:00) Central
Time (US & Canada)
2Oct-17-2020 18:21:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-12-2020 13:59:16 (UTC-06:00) Central
Time (US & Canada)
2Oct-06-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Oct-05-2020 15:27:39 (UTC-06:00) Central
Time (US & Canada)
2Sep-30-2020 14:12:00 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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)
FDA-CBER-2021-5683-0794761
Page 166 of 501
***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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-27-2020 19:28:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-27-2020 19:27:09 (UTC-06:00) Central
Time (US & Canada)
3Oct-17-2020 18:21:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-12-2020 13:59:16 (UTC-06:00) Central
Time (US & Canada)
3Oct-06-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Oct-05-2020 15:27:59 (UTC-06:00) Central
Time (US & Canada)
3Sep-30-2020 14:12:19 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\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)
FDA-CBER-2021-5683-0794762
Page 167 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:20:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794763
Page 168 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:20:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794764
Page 169 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:20:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794765
Page 170 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:20:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794766
Page 171 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:20:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794767
Page 172 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794768
Page 173 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794769
Page 174 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794770
Page 175 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794771
Page 176 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794772
Page 177 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794773
Page 178 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794774
Page 179 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794775
Page 180 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794776
Page 181 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794777
Page 182 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794778
Page 183 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794779
Page 184 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794780
Page 185 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794781
Page 186 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794782
Page 187 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794783
Page 188 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794784
Page 189 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794785
Page 190 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794786
Page 191 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794787
Page 192 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794788
Page 193 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794789
Page 194 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794790
Page 195 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794791
Page 196 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794792
Page 197 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794793
Page 198 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794794
Page 199 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794795
Page 200 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794796
Page 201 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794797
Page 202 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794798
Page 203 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794799
Page 204 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:17 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794800
Page 205 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794801
Page 206 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794802
Page 207 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794803
Page 208 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794804
Page 209 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794805
Page 210 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794806
Page 211 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794807
Page 212 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794808
Page 213 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794809
Page 214 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794810
Page 215 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794811
Page 216 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794812
Page 217 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794813
Page 218 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794814
Page 219 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794815
Page 220 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794816
Page 221 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794817
Page 222 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794818
Page 223 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794819
Page 224 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794820
Page 225 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794821
Page 226 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794822
Page 227 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794823
Page 228 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794824
Page 229 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794825
Page 230 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794826
Page 231 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794827
Page 232 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794828
Page 233 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 fNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794829
Page 234 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794830
Page 235 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794831
Page 236 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794832
Page 237 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794833
Page 238 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794834
Page 239 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794835
Page 240 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794836
Page 241 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5 hNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794837
Page 242 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794838
Page 243 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794839
Page 244 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794840
Page 245 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794841
Page 246 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794842
Page 247 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794843
Page 248 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794844
Page 249 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-16-2020 20:21:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794845
Page 250 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794846
Page 251 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794847
Page 252 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aNov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794848
Page 253 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aNov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794849
Page 254 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aNov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794850
Page 255 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aNov-16-2020 20:21:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794851
Page 256 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:22:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794852
Page 257 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:22:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794853
Page 258 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aNov-16-2020 20:22:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794854
Page 259 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: OXYGENATION PARAMETERS - 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:22:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794855
Page 260 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: OXYGENATION PARAMETERS - 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:22:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794856
Page 261 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: OXYGENATION PARAMETERS - 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:22:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794857
Page 262 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: OXYGENATION PARAMETERS - 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: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:22:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794858
Page 263 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794859
Page 264 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794860
Page 265 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794861
Page 266 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794862
Page 267 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794863
Page 268 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794864
Page 269 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-16-2020 20:22:43 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794865
Page 270 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-16-2020 20:32:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794866
Page 271 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-16-2020 20:32:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794867
Page 272 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-16-2020 20:32:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794868
Page 273 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-16-2020 20:32:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794869
Page 274 of 501
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/14/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-16-2020 20:32:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0794870
Page 275 of 501
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
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 12:12:40 (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.
 N/A Dec-15-2020 10:27:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-17-2020 17:58:25 (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.
 N/A Nov-07-2020 21:05:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794871
Page 276 of 501
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
 Approved Oct-30-2020 16:15:16 (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.
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794872
Page 277 of 501
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 19:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020 19:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794873
Page 278 of 501
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 19:45:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/3/2020Initial Entry
090177e196ae3dc7\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0794874
Page 279 of 501
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171086 Subject Initials: ---
Generated By: Generated Time
…[truncated]