Document text
Page 1 of 616
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795672
Page 2 of 616
***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: 11171141 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/22/2020
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795673
Page 3 of 616
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11171141]
2.Birth Date: 1947
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795674
Page 4 of 616
***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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795675
Page 5 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795676
Page 6 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795677
Page 7 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:[CANCER, CERVICAL]
Start Date: Jul/15/1992
Ongoing: NO
End Date:
Jul/31/1992
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYSTERECTOMY, TOTAL]
Start Date: Jul/31/1992
Ongoing: NO
End Date:
Jul/31/1992
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795678
Page 8 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RESTLESS LEG SYNDROME]
Start Date: UNK/UNK/2005
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ANEMIA]
Start Date: May/UNK/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OBSTRUCTIVE SLEEP APNEA]
Start Date: May/UNK/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BARRETT'S SYNDROME]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795679
Page 9 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BULGING DISC, LUMBAR]
Start Date: UNK/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OSTEOARTHRITIS, HIP, BILATERAL]
Start Date: UNK/UNK/2016
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HERNIA, ABDOMINAL]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
Dec/UNK/1995
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795680
Page 10 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TONSILLITIS]
Start Date: Apr/UNK/1977
Ongoing: NO
End Date:
Apr/UNK/1977
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TONSILLECTOMY]
Start Date: Apr/UNK/1977
Ongoing: NO
End Date:
Apr/UNK/1977
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OSTEOARTHRITIS, KNEE, BILATERAL]
Start Date: UNK/UNK/1967
Ongoing: YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795681
Page 11 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ARTHROSCOPIC SURGERY, KNEE, BILATERAL]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[IDIOPATHIC NEUROPATHY, LOWER EXTREMITY, LEFT]
Start Date: May/UNK/2020
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHOLELITHIASIS]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795682
Page 12 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:[CHOLECYCSTECTEMY]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CATARACTS, BILATERAL]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2018
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CATARACT REMOVAL, BILATERAL]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795683
Page 13 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[VISION IMPAIRMENT, BILATERAL]
Start Date: UNK/UNK/1966
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CARPAL TUNNEL SYNDROME, RIGHT]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2019
1.vLine/MH Number: [22]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CARPAL TUNNEL RELEASE, RIGHT]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795684
Page 14 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.wLine/MH Number: [23]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ECTOPIC PREGNANCY]
Start Date: UNK/UNK/1972
Ongoing: NO
End Date:
UNK/UNK/1972
1.xLine/MH Number: [24]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[EDEMA, LOW EXTERMITY, LEFT]
Start Date: UNK/UNK/2018
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HERPES LABIALIS]
Start Date: UNK/UNK/1970
Ongoing: YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795685
Page 15 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.zLine/MH Number: [26]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHRONIC LOW BACK PAIN]
Start Date: UNK/UNK/2016
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HERNIA REPAIR, ABDOMINAL]
Start Date: UNK/UNK/1989
Ongoing: NO
End Date:
UNK/UNK/1989
1.abLine/MH Number: [28]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[HERNIA REPAIR, ABDOMINAL]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795686
Page 16 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.acLine/MH Number: [29]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[PEPTIC ULCER]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.adLine/MH Number: [30]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BRONCHITIS, CHRONIC]
Start Date: UNK/UNK/2018
Ongoing: YES
1.aeLine/MH Number: [31]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[PNEUMONIA]
Start Date: Feb/UNK/2018
Ongoing: NO
End Date:
Dec/UNK/2019
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795687
Page 17 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.afLine/MH Number: [32]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[MORBID OBESITY]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795688
Page 18 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795689
Page 19 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
2.Weight: [256.8]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [44.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795690
Page 20 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795691
Page 21 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/22/2020
2.Randomization Number: [262947]
3.Randomization Group: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795692
Page 22 of 616
***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: 11171141 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/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 [BM8YN6]
5.bSample ID [BM8YN5]
5.cSample ID [BM8YN4]
5.dSample ID [BPRV54]
5.eSample ID [BPRV53]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795693
Page 23 of 616
***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: 11171141 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 [BM8YKF]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795694
Page 24 of 616
***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: 11171141 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 10:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795695
Page 25 of 616
***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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795696
Page 26 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795697
Page 27 of 616
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795698
Page 28 of 616
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/13/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795699
Page 29 of 616
***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: 11171141 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:
Oct/13/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ8G2]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795700
Page 30 of 616
***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: 11171141 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: Oct/13/2020 12:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795701
Page 31 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795702
Page 32 of 616
***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: 11171141 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:
Nov/11/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRSRVN]
5.bSample ID [BRSRVP]
5.cSample ID [BM8YS2]
5.dSample ID [BRDFK1]
5.eSample ID [BRDFK2]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795703
Page 33 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795704
Page 34 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/7/2020
2.Date of First Symptom
Started:Dec/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/25/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795705
Page 35 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [RUNNY NOSE]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795706
Page 36 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descri
ptionDevice TypeForm Insta
nce
1.Dec/2/2
020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTIC
TEST Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795707
Page 37 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and
Description:SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA CERTIFIED LAB]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795708
Page 38 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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_SELF
3.Sample Collected? YES
Date of Collection:
Dec/6/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV11473]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795709
Page 39 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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? NO
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[SEE SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795710
Page 40 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795711
Page 41 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795712
Page 42 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1.Not Done Not Done Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795713
Page 43 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795714
Page 44 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19
Illness?NO
3.Toxicity Grade: 2
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795715
Page 45 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical
Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795716
Page 46 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795717
Page 47 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Done Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done
Not Done Not
Done Not
Done Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795718
Page 48 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
AddressNot 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795719
Page 49 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795720
Page 50 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795721
Page 51 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795722
Page 52 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795723
Page 53 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795724
Page 54 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795725
Page 55 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.Not Done Not Done Not Don
e Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
DoneNot
DoneRepeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795726
Page 56 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category f
or Lab Tes
tVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795727
Page 57 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
AddressNot 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795728
Page 58 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795729
Page 59 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795730
Page 60 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795731
Page 61 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795732
Page 62 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795733
Page 63 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795734
Page 64 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795735
Page 65 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795736
Page 66 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795737
Page 67 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795738
Page 68 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795739
Page 69 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795740
Page 70 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795741
Page 71 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Done Not Done Not Done Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795742
Page 72 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795743
Page 73 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.Not Done Not Done Not Done Not Done Not D
one Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795744
Page 74 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795745
Page 75 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessm
entLocation of Assess
mentImaging Meth
odOverall Assessm
entForm Instance
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795746
Page 76 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795747
Page 77 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795748
Page 78 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:
Jan/6/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDFP5]
5.bSample ID [BRDFP6]
5.cSample ID [BRDFP7]
5.dSample ID [BSFB37]
5.eSample ID [BSFB38]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795749
Page 79 of 616
***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: 11171141 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:
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795750
Page 80 of 616
***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: 11171141 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 [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795751
Page 81 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795752
Page 82 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795753
Page 83 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
1.ADVER
SE EVE
NT 1 THIGH MUSCLE, ST
RAIN, LEFT Oct/11/2020
UNK:UNK NO
End Date Time:
Oct/17/2020 U
NK:UNK
Repeating
Pages
2.ADVER
SE EVE
NT 2 SMALL BOWEL OBS
TRUCTION Nov/27/202
0 UNK:UN
K NO
End Date Time:
Nov/30/2020
UNK:UNK
Repeating
Pages
3.ADVER
SE EVE
NT 3 SMALL BOWEL OBS
TRUCTION Dec/27/2020
UNK:UNK NO
End Date Time:
Dec/30/2020
UNK:UNK
Repeating
Pages
4.ADVER
SE EVE
NT 4 HEPATIC STEATOSIS
Nov/27/202
0 UNK:UN
K YES Repeating
Pages
5.ADVER
SE EVE
NT 5 HEPATIC CYST Nov/27/202
0 UNK:UN
K YES Repeating
Pages
6.ADVER
SE EVE
NT 6 INFRAUMBILICAL V
ENTRAL HERNIA Dec/27/2020
UNK:UNK YES Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795754
Page 84 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
7.ADVER
SE EVE
NT 7 SWOLLEN LYMPH N
ODES, RIGHT CERVI
CAL Jan/23/2021
UNK:UNK NO
End Date Time:
Jan/27/2021 U
NK:UNK
Repeating
Pages
8.ADVER
SE EVE
NT 8 TOE INFLAMMATIO
N, GREAT TOE, LEFT
Jan/19/2021
UNK:UNK NO
End Date Time:
Jan/26/2021 U
NK:UNK
Repeating
Pages
9.ADVER
SE EVE
NT 9 ABNORMAL THRYO
ID LABORATORY VA
LUES Nov/UNK/2
020 UNK:U
NK YES Repeating
Pages
10.ADVER
SE EVE
NT 10 ACTINIC KERATOSI
S, SCALP, WORSENI
NG Jan/UNK/20
21 UNK:UN
K YES Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795755
Page 85 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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)[THIGH MUSCLE, STRAIN, LEFT]
4.Start Date Time: Oct/11/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/17/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795756
Page 86 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[INCIDENTAL MIS-STEP FROM CURB]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795757
Page 87 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795758
Page 88 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[SMALL BOWEL OBSTRUCTION]
4.Start Date Time: Nov/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/30/2020 UNK:UNK
6.Toxicity Grade: 4
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795759
Page 89 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ETIOLOGY UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795760
Page 90 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020471440]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795761
Page 91 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[SMALL BOWEL OBSTRUCTION]
4.Start Date Time: Dec/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/30/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795762
Page 92 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[INTRAABDOMINAL SCAR FORMATION FROM
PRIOR SURGERIES]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795763
Page 93 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020520647]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795764
Page 94 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[HEPATIC STEATOSIS]
4.Start Date Time: Nov/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795765
Page 95 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[MORBID OBESITY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795766
Page 96 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795767
Page 97 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[HEPATIC CYST]
4.Start Date Time: Nov/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795768
Page 98 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ETIOLOGY UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795769
Page 99 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795770
Page 100 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[INFRAUMBILICAL VENTRAL HERNIA]
4.Start Date Time: Dec/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795771
Page 101 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[MORBID OBESITY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795772
Page 102 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795773
Page 103 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[SWOLLEN LYMPH NODES, RIGHT CERVICAL]
4.Start Date Time: Jan/23/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795774
Page 104 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ETILOGY UNKNOWN]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795775
Page 105 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795776
Page 106 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[TOE INFLAMMATION, GREAT TOE, LEFT]
4.Start Date Time: Jan/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795777
Page 107 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[INGROWN TOE NAIL]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795778
Page 108 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795779
Page 109 of 616
***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: 11171141 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: [9]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ABNORMAL THRYOID LABORATORY VALUES]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795780
Page 110 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNKNOWN ETIOLOGY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795781
Page 111 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795782
Page 112 of 616
***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: 11171141 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: [10]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ACTINIC KERATOSIS, SCALP, WORSENING]
4.Start Date Time: Jan/UNK/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795783
Page 113 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PREEXISTING CONDITION]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795784
Page 114 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795785
Page 115 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedication
ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795786
Page 116 of 616
***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: 11171141 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[ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795787
Page 117 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO FLU VACCI
NATION Nov/3/
2020 Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795788
Page 118 of 616
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[FLU VACCINATION]
5.Date: Nov/3/2020
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795789
Page 119 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795790
Page 120 of 616
***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: 11171141 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?
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795791
Page 121 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795792
Page 122 of 616
***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: 11171141 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?
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795793
Page 123 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795794
Page 124 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795795
Page 125 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795796
Page 126 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795797
Page 127 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11171141 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:
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795798
Page 128 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795799
Page 129 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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?
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795800
Page 130 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795801
Page 131 of 616
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795802
Page 132 of 616
***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: 11171141 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: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795803
Page 133 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795804
Page 134 of 616
***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, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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 per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795805
Page 135 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795806
Page 136 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795807
Page 137 of 616
***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: 11171141 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: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795808
Page 138 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795809
Page 139 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/6/2021
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795810
Page 140 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795811
Page 141 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795812
Page 142 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/14/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795813
Page 143 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:
Jan/14/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDFSS]
5.bSample ID [BRDFST]
5.cSample ID [BRDFSV]
5.dSample ID [BRSRGM]
5.eSample ID [BRSRGN]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795814
Page 144 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:
Jan/14/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDFN0]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795815
Page 145 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/14/2021 14:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795816
Page 146 of 616
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795817
Page 147 of 616
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/4/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795818
Page 148 of 616
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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:
Feb/4/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6RTK]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795819
Page 149 of 616
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 14:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795820
Page 150 of 616
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795821
Page 151 of 616
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/9/2021
3.Comments: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795822
Page 152 of 616
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795823
Page 153 of 616
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795824
Page 154 of 616
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795825
Page 155 of 616
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795826
Page 156 of 616
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795827
Page 157 of 616
***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: 11171141 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 Nov/11/2020
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795828
Page 158 of 616
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11171141 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
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4)
FDA-CBER-2021-5683-0795829
Page 159 of 616
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11171141 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-12-2021 13:19:03 (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.
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795830
Page 160 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-04-2020 19:40:41 (UTC-06:00)
Central Time (US & Canada)
2Sep-28-2020 14:30:21 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795831
Page 161 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-28-2020 14:30:46 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795832
Page 162 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-28-2020 14:31:20 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795833
Page 163 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:25:37 (UTC-06:00)
Central Time (US & Canada)
4Sep-29-2020 16:56:15 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795834
Page 164 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-06-2020 16:25:50 (UTC-06:00)
Central Time (US & Canada)
4Sep-29-2020 16:44:39 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795835
Page 165 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795836
Page 166 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795837
Page 167 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795838
Page 168 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795839
Page 169 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795840
Page 170 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795841
Page 171 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-09-2020 11:48:27 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795842
Page 172 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:49:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0795843
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Visit: POT_COVID_ILL 1 -
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Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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ItemDate User Comment
1Dec-09-2020 11:49:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795844
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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ItemDate User Comment
2Dec-09-2020 11:49:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795845
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
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Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:49:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795846
Page 176 of 616
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:49:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795847
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795848
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***Confidential***
Header Text: c4591001
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Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795849
Page 179 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795850
Page 180 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795851
Page 181 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795852
Page 182 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795853
Page 183 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795854
Page 184 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795855
Page 185 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795856
Page 186 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795857
Page 187 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795858
Page 188 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795859
Page 189 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795860
Page 190 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795861
Page 191 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795862
Page 192 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795863
Page 193 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795864
Page 194 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795865
Page 195 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795866
Page 196 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795867
Page 197 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795868
Page 198 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795869
Page 199 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795870
Page 200 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795871
Page 201 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795872
Page 202 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795873
Page 203 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795874
Page 204 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795875
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Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795876
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795877
Page 207 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795878
Page 208 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795879
Page 209 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:40 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795880
Page 210 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795881
Page 211 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795882
Page 212 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795883
Page 213 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795884
Page 214 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795885
Page 215 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795886
Page 216 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795887
Page 217 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795888
Page 218 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795889
Page 219 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795890
Page 220 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795891
Page 221 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795892
Page 222 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795893
Page 223 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795894
Page 224 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795895
Page 225 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795896
Page 226 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795897
Page 227 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795898
Page 228 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795899
Page 229 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795900
Page 230 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795901
Page 231 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795902
Page 232 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795903
Page 233 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795904
Page 234 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795905
Page 235 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795906
Page 236 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795907
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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ItemDate User Comment
5.fDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795908
Page 238 of 616
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Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795909
Page 239 of 616
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795910
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Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795911
Page 241 of 616
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795912
Page 242 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795913
Page 243 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795914
Page 244 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795915
Page 245 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795916
Page 246 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795917
Page 247 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795918
Page 248 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795919
Page 249 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795920
Page 250 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795921
Page 251 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795922
Page 252 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795923
Page 253 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795924
Page 254 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jDec-09-2020 11:49:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795925
Page 255 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795926
Page 256 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795927
Page 257 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aDec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795928
Page 258 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aDec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795929
Page 259 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aDec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795930
Page 260 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aDec-09-2020 11:50:36 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795931
Page 261 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:50:51 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795932
Page 262 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:50:51 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795933
Page 263 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2.aDec-09-2020 11:50:51 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795934
Page 264 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:51:06 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795935
Page 265 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:51:06 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795936
Page 266 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:51:06 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795937
Page 267 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:51:06 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795938
Page 268 of 616
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795939
Page 269 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795940
Page 270 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795941
Page 271 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795942
Page 272 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795943
Page 273 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795944
Page 274 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-09-2020 11:51:22 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795945
Page 275 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-09-2020 11:51:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795946
Page 276 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-09-2020 11:51:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795947
Page 277 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-09-2020 11:51:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795948
Page 278 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-09-2020 11:51:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795949
Page 279 of 616
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-09-2020 11:51:57 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795950
Page 280 of 616
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-16-2021 17:09:17 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0795951
Page 281 of 616
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11171141 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-12-2021 13:19:03 (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 Mar-11-2021 12:47:04 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-10-2021 11:12:57 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795952
Page 282 of 616
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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-01-2020 15:47:41 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Larkin
Wadsworth Approved Nov-13-2020 19:40:44 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LarkinWadsworth, 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.
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795953
Page 283 of 616
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
N/A Nov-12-2020 17:59:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 17:47:16 (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.
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795954
Page 284 of 616
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 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-28-2020
14:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020
14:28:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795955
Page 285 of 616
***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: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020
14:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/22/2020Initial Entry
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795956
Page 286 of 616
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-28-2020
14:28:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11171141Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-28-2020
14:28:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1947Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-28-2020
14:29:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795957
Page 287 of 616
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-28-2020
14:29:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-28-2020
14:29:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3dca\Final\Final On: 01-Apr-2021 04:41 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0795958
Page 288 of 616
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1117 Site Name: (1117) Sundance Clinical Research
Subject No: 11171141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020
06:48:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-30-2020
15:01:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answere
dOriginal value is
correct
Sep-29-2020
11:56:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000
…[truncated]