125742 S1 M5 CRF c4591001 1095 10951197

Document text

Page 1 of 917
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022704
Page 2 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022705
Page 3 of 917
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951197]
2.Birth Date: /1982
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:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022706
Page 4 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022707
Page 5 of 917
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022708
Page 6 of 917
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022709
Page 7 of 917
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Jan/1/1996
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Degenerative disc disease]
Start Date: Jan/1/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: Jan/1/1993
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Epstein-Barr based on high IgG titers without acute infection]
Start Date: Jan/1/2019
Ongoing: YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022710
Page 8 of 917
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibromyalgia]
Start Date: Jan/1/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iron deficient anemia]
Start Date: Jan/1/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Irritable bowel syndrome]
Start Date: Jan/1/2012
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[pyelonephritis (both kidneys)]
Start Date: Apr/UNK/2017
Ongoing: NO
End Date:
Apr/UNK/2017
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022711
Page 9 of 917
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ovarian cysts]
Start Date: Jan/1/2016
Ongoing: NO
End Date:
Jan/1/2016
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[laperoscopic cyst removal]
Start Date: Jan/UNK/2016
Ongoing: NO
End Date:
Jan/UNK/2016
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spinal stenosis]
Start Date: Jan/1/2013
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: Jan/UNK/1990
Ongoing: YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022712
Page 10 of 917
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitiligo]
Start Date: Jan/1/1994
Ongoing: YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022713
Page 11 of 917
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [84.6]
3.Unit: kg
4.Height: [176.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022714
Page 12 of 917
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022715
Page 13 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [77334]
3.Randomization Group: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022716
Page 14 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPY2XR]
5.bSample ID [BPY2XS]
5.cSample ID [BPY2XT]
5.dSample ID [BPCT4C]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022717
Page 15 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP3BJ9]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022718
Page 16 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/1/2020 16:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022719
Page 17 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022720
Page 18 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022721
Page 19 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022722
Page 20 of 917
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022723
Page 21 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP1MMY ]
5.bSample ID [BP1MMZ ]
5.cSample ID [BP1MN0 ]
5.dSample ID [BP1N70]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022724
Page 22 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Oct/5/2020
Reason(s) for Temporary Delay of Vaccination
RECENT SYSTEMIC CORTICOSTEROID TREATMENT
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/19/2020 16:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022725
Page 23 of 917
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022726
Page 24 of 917
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BPLJXF]
5.bSample ID [BRDG34]
5.cSample ID [BRDG35]
5.dSample ID [BRDG36]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022727
Page 25 of 917
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022728
Page 26 of 917
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022729
Page 27 of 917
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022730
Page 28 of 917
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022731
Page 29 of 917
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022732
Page 30 of 917
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022733
Page 31 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022734
Page 32 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/21/2020
2.Date of First Symptom Started: Sep/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/3/2020
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? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022735
Page 33 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Symptoms - Other
5.aSymptoms - Other Text: [Chills]
5.bSymptoms - Other Text: [Diarrhea]
5.cSymptoms - Other Text: [muscle pain ]
5.dSymptoms - Other Text: [vomiting]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022736
Page 34 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Insta
nce
 1. DELETED Sep/21/2
020 SWABBED
MATERIAL
 NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022737
Page 35 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/21/2020
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 COV2 DIAGNOSTIC TEST
6.Trade Name: Not Applicable Comments
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022738
Page 36 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV17728]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022739
Page 37 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[self swab collected] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022740
Page 38 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022741
Page 39 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022742
Page 40 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022743
Page 41 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[upper respiratory infection]
Date of Diagnosis:
Sep/21/2020Comments
3.Toxicity Grade: 2 Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022744
Page 42 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022745
Page 43 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022746
Page 44 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest: Result:
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne 
Not Done  Not Applic
able Not Do
ne Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022747
Page 45 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022748
Page 46 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022749
Page 47 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022750
Page 48 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022751
Page 49 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one 
Not Done  Not Appli
cable Not D
one Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022752
Page 50 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022753
Page 51 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022754
Page 52 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022755
Page 53 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022756
Page 54 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022757
Page 55 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022758
Page 56 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Applicable  Not Done  Not Done Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022759
Page 57 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022760
Page 58 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Applicable  Not Done Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022761
Page 59 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022762
Page 60 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022763
Page 61 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022764
Page 62 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022765
Page 63 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022766
Page 64 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022767
Page 65 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022768
Page 66 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022769
Page 67 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/29/2020
2.Date of First Symptom Started: Dec/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/31/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022770
Page 68 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Symptoms - Other
5.aSymptoms - Other Text: [elevated temp-99.9 F]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022771
Page 69 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022772
Page 70 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022773
Page 71 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Spoke with participant today and she reports she did not swab.PD written.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022774
Page 72 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:[patient took self-swab at home]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022775
Page 73 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022776
Page 74 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022777
Page 75 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022778
Page 76 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Viral URI]
Date of Diagnosis:
Dec/29/2020
3.Toxicity Grade: 2
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022779
Page 77 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022780
Page 78 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022781
Page 79 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022782
Page 80 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022783
Page 81 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022784
Page 82 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022785
Page 83 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022786
Page 84 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022787
Page 85 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022788
Page 86 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022789
Page 87 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022790
Page 88 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022791
Page 89 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022792
Page 90 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022793
Page 91 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022794
Page 92 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022795
Page 93 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022796
Page 94 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022797
Page 95 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022798
Page 96 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022799
Page 97 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022800
Page 98 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022801
Page 99 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022802
Page 100 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022803
Page 101 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022804
Page 102 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/28/2021
2.Date of First Symptom Started: Jan/25/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/27/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022805
Page 103 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Symptoms - Other
5.aSymptoms - Other Text: [elevated temp 99.9]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022806
Page 104 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022807
Page 105 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022808
Page 106 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [CV00540]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022809
Page 107 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:[Participant will complete home swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022810
Page 108 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022811
Page 109 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022812
Page 110 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022813
Page 111 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[viral upper respiratory infection]
Date of Diagnosis:
Jan/28/2021
3.Toxicity Grade: 1
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022814
Page 112 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022815
Page 113 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022816
Page 114 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022817
Page 115 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022818
Page 116 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022819
Page 117 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022820
Page 118 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022821
Page 119 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022822
Page 120 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022823
Page 121 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022824
Page 122 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022825
Page 123 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022826
Page 124 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022827
Page 125 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022828
Page 126 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022829
Page 127 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022830
Page 128 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022831
Page 129 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022832
Page 130 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022833
Page 131 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022834
Page 132 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022835
Page 133 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022836
Page 134 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022837
Page 135 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/28/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022838
Page 136 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/19/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022839
Page 137 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/19/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP1MMY]
5.bSample ID [BP1MMZ]
5.cSample ID [BP1MN0]
5.dSample ID [BPLJSP]
5.eSample ID [BPLJSR]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022840
Page 138 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022841
Page 139 of 917
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BRBTJ5]
5.bSample ID [BRBTJ6]
5.cSample ID [BRBTJ7]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022842
Page 140 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/21/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022843
Page 141 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/21/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022844
Page 142 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/21/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/21/2020
Contact Outcome:
VISIT NOT ARRANGED, UNABLE TO ATTEND
3.Comments: [Subject reports productive cough, sore throat and myalgia for 3 days. Denies
fever or other symptoms. Subject spoke with co-PI. Subject will do nasal swab at
home as instructed.]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022845
Page 143 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022846
Page 144 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022847
Page 145 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Nov/2/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022848
Page 146 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022849
Page 147 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Nov/2/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: NO
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
5.cSymptom: HEADACHE
Symptom Present: NO
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: NO
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022850
Page 148 of 917
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Nov/02/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022851
Page 149 of 917
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022852
Page 150 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022853
Page 151 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022854
Page 152 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022855
Page 153 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  upper respiratory infectio
n Sep/19/2020 U
NK:UNK NO
End Date Time:
Oct/3/2020 UNK:U
NK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Fixed drug erruption on f
eet bilaterally Oct/26/2020 U
NK:UNK YES  Repeating
Pages
 3. ADVERSE
EVENT 3  exacerbation of Degener
ative Disc Disease Jan/14/2021 U
NK:UNK NO
End Date Time:
Jan/15/2021 UNK:
UNK
 Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022856
Page 154 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[upper respiratory infection ]
4.Start Date Time: Sep/19/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[viral infection ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022857
Page 155 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022858
Page 156 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[Fixed drug erruption on feet bilaterally]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022859
Page 157 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022860
Page 158 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[exacerbation of Degenerative Disc Disease]
4.Start Date Time: Jan/14/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/15/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022861
Page 159 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[DEGENERATIVE DISC DISEASE]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2021218683]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022862
Page 160 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022863
Page 161 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022864
Page 162 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022865
Page 163 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022866
Page 164 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022867
Page 165 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022868
Page 166 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022869
Page 167 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022870
Page 168 of 917
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022871
Page 169 of 917
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022872
Page 170 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022873
Page 171 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022874
Page 172 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022875
Page 173 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022876
Page 174 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022877
Page 175 of 917
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022878
Page 176 of 917
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022879
Page 177 of 917
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022880
Page 178 of 917
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022881
Page 179 of 917
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022882
Page 180 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022883
Page 181 of 917
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022884
Page 182 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/23/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022885
Page 183 of 917
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022886
Page 184 of 917
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022887
Page 185 of 917
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/17/2020
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022888
Page 186 of 917
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022889
Page 187 of 917
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022890
Page 188 of 917
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-01-2020 16:41:50 (UTC-06:00) Central
Time (US & Canada)N/A
FormSep-01-2020 16:41:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022891
Page 189 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Oct-06-2020 08:41:17 (UTC-06:00) Central Time
(US & Canada)entered information incorrectly. COVID
microbiology specimen not collected
Not Applicable
6Sep-30-2020 14:18:44 (UTC-06:00) Central
Time (US & Canada)entered information incorrectly. COVID
microbiology specimen not collected
6Sep-30-2020 12:59:00 (UTC-06:00) Central
Time (US & Canada)entered information incorrectly.
Not Done
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022892
Page 190 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-03-2020 08:23:54 (UTC-06:00) Central
Time (US & Canada)
FormSep-30-2020 13:48:53 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-29-2020 14:59:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022893
Page 191 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-03-2020 08:23:54 (UTC-06:00) Central
Time (US & Canada)
1Sep-30-2020 13:48:53 (UTC-06:00) Central
Time (US & Canada)Not Done
1Sep-29-2020 14:59:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022894
Page 192 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-03-2020 08:23:54 (UTC-06:00) Central
Time (US & Canada)
2Sep-30-2020 13:48:53 (UTC-06:00) Central
Time (US & Canada)Not Done
2Sep-29-2020 14:59:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022895
Page 193 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-03-2020 08:23:54 (UTC-06:00) Central
Time (US & Canada)
3Sep-30-2020 13:48:53 (UTC-06:00) Central
Time (US & Canada)Not Done
3Sep-29-2020 14:59:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022896
Page 194 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-03-2020 08:23:54 (UTC-06:00) Central
Time (US & Canada)
4Sep-30-2020 13:48:53 (UTC-06:00) Central
Time (US & Canada)Not Done
4Sep-29-2020 14:59:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022897
Page 195 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-21-2020 09:16:36 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-19-2020 18:07:43 (UTC-06:00) Central
Time (US & Canada)
FormSep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022898
Page 196 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
1Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
1Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022899
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
2Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
2Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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(6)
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FDA-CBER-2021-5683-1022900
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
3Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
3Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1022901
Page 199 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
4Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
4Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
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FDA-CBER-2021-5683-1022902
Page 200 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
5Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
5Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
5Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022903
Page 201 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Oct-21-2020 09:16:36 (UTC-06:00) Central Time
(US & Canada)Not Done
6Oct-19-2020 18:07:43 (UTC-06:00) Central Time
(US & Canada)
6Sep-30-2020 13:49:23 (UTC-06:00) Central
Time (US & Canada)Not Done
6Sep-29-2020 15:00:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
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FDA-CBER-2021-5683-1022904
Page 202 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-30-2020 14:15:27 (UTC-06:00) Central
Time (US & Canada)
FormSep-29-2020 15:00:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1022905
Page 203 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-30-2020 14:15:27 (UTC-06:00) Central
Time (US & Canada)
1Sep-29-2020 15:00:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022906
Page 204 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-30-2020 14:15:27 (UTC-06:00) Central
Time (US & Canada)
2Sep-29-2020 15:00:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022907
Page 205 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-30-2020 14:15:27 (UTC-06:00) Central
Time (US & Canada)
3Sep-29-2020 15:00:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022908
Page 206 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-21-2020 09:16:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-21-2020 08:44:58 (UTC-06:00) Central
Time (US & Canada)
FormOct-21-2020 08:25:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-19-2020 18:07:59 (UTC-06:00) Central
Time (US & Canada)
FormSep-29-2020 15:00:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022909
Page 207 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-21-2020 09:16:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-21-2020 08:44:58 (UTC-06:00) Central Time
(US & Canada)
1Oct-21-2020 08:25:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Oct-19-2020 18:07:59 (UTC-06:00) Central Time
(US & Canada)
1Sep-29-2020 15:00:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022910
Page 208 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-21-2020 09:16:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-21-2020 08:44:58 (UTC-06:00) Central Time
(US & Canada)
2Oct-21-2020 08:25:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Oct-19-2020 18:07:59 (UTC-06:00) Central Time
(US & Canada)
2Sep-29-2020 15:00:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022911
Page 209 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-21-2020 09:16:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-21-2020 08:44:58 (UTC-06:00) Central Time
(US & Canada)
3Oct-21-2020 08:25:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Oct-19-2020 18:07:59 (UTC-06:00) Central Time
(US & Canada)
3Sep-29-2020 15:00:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022912
Page 210 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-21-2020 09:16:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-21-2020 08:44:58 (UTC-06:00) Central Time
(US & Canada)
4Oct-21-2020 08:25:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Oct-19-2020 18:07:59 (UTC-06:00) Central Time
(US & Canada)
4Sep-29-2020 15:00:39 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
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(6)
(b) (4)
FDA-CBER-2021-5683-1022913
Page 211 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-21-2020 09:16:58 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-19-2020 18:08:13 (UTC-06:00) Central
Time (US & Canada)
FormSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022914
Page 212 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
1Sep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
1Sep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1022915
Page 213 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
2Sep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
2Sep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1022916
Page 214 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
3Sep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
3Sep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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FDA-CBER-2021-5683-1022917
Page 215 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
4Sep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
4Sep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
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(6)
(b) (4)
FDA-CBER-2021-5683-1022918
Page 216 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
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(b) (4), (b) 
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FDA-CBER-2021-5683-1022919
Page 217 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
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(b) (4)
FDA-CBER-2021-5683-1022920
Page 218 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022921
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022922
Page 220 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022923
Page 221 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022924
Page 222 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022925
Page 223 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1022926
Page 224 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022927
Page 225 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022928
Page 226 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022929
Page 227 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022930
Page 228 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022931
Page 229 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022932
Page 230 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022933
Page 231 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022934
Page 232 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.eSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.eSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022935
Page 233 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.eSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.eSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022936
Page 234 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.eSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.eSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022937
Page 235 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.eOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.eSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.eSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022938
Page 236 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5 fSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5 fSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022939
Page 237 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5 fSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5 fSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022940
Page 238 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5 fSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5 fSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022941
Page 239 of 917
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5 fOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5 fOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5 fSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5 fSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022942
Page 240 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.gSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.gSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022943
Page 241 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.gSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.gSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022944
Page 242 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.gSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.gSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022945
Page 243 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:16:58 (UTC-06:00) Central Time
(US & Canada)Not Done
5.gOct-19-2020 18:08:13 (UTC-06:00) Central Time
(US & Canada)
5.gSep-30-2020 13:50:13 (UTC-06:00) Central
Time (US & Canada)Not Done
5.gSep-29-2020 15:01:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022946
Page 244 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-21-2020 09:17:10 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-19-2020 18:08:26 (UTC-06:00) Central
Time (US & Canada)
FormSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
FormSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022947
Page 245 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
1Sep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
1Sep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022948
Page 246 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
2Sep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
2Sep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022949
Page 247 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
3Sep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
3Sep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022950
Page 248 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
4Sep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
4Sep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022951
Page 249 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022952
Page 250 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022953
Page 251 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022954
Page 252 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.aOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.aSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.aSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022955
Page 253 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022956
Page 254 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022957
Page 255 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022958
Page 256 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.bOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.bSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.bSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022959
Page 257 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022960
Page 258 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022961
Page 259 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022962
Page 260 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.cOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.cSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.cSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022963
Page 261 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022964
Page 262 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:17:10 (UTC-06:00) Central Time
(US & Canada)Not Done
5.dOct-19-2020 18:08:26 (UTC-06:00) Central Time
(US & Canada)
5.dSep-30-2020 13:50:27 (UTC-06:00) Central
Time (US & Canada)Not Done
5.dSep-29-2020 15:02:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fbc\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022965
Page 263 of 917
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research

…[truncated]