125742 S1 M5 CRF c4591001 1095 10951173

Document text

Page 1 of 220
***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: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022348
Page 2 of 220
***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: 10951173 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
Aug/29/2020
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022349
Page 3 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951173]
2.Birth Date: 1971
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022350
Page 4 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022351
Page 5 of 220
***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: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022352
Page 6 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022353
Page 7 of 220
***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: 10951173 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:[seasonal allergies]
Start Date: UNK/UNK/2006
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022354
Page 8 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
2.Weight: [87.5]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [31.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022355
Page 9 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/29/2020
2.Randomization Number: [74020]
3.Randomization Group: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022356
Page 10 of 220
***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: 10951173 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:
Aug/29/2020
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 [BPCT38]
5.bSample ID [BPCT39]
5.cSample ID [BPY2VR]
5.dSample ID [BPY2VS]
5.eSample ID [BPY2VT]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022357
Page 11 of 220
***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: 10951173 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:
Aug/29/2020
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 [BP3BHM]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022358
Page 12 of 220
***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: 10951173 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: Aug/29/2020 15:16
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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022359
Page 13 of 220
***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: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022360
Page 14 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022361
Page 15 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022362
Page 16 of 220
***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: 10951173 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/12/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[No nasal swab or vaccine administered due to SAE]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1N5T]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022363
Page 17 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022364
Page 18 of 220
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022365
Page 19 of 220
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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/11/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLJWV]
5.bSample ID [BRDG1M]
5.cSample ID [BRDG1N]
5.dSample ID [BRDG1P]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022366
Page 20 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022367
Page 21 of 220
***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: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022368
Page 22 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022369
Page 23 of 220
***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: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022370
Page 24 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022371
Page 25 of 220
***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: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022372
Page 26 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022373
Page 27 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022374
Page 28 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022375
Page 29 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022376
Page 30 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
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?
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022377
Page 31 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022378
Page 32 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022379
Page 33 of 220
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022380
Page 34 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022381
Page 35 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022382
Page 36 of 220
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/5/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022383
Page 37 of 220
***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: 10951173 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: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022384
Page 38 of 220
***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: 10951173 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:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022385
Page 39 of 220
***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: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022386
Page 40 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  STEMI: ST elevation Myo
cardial Infarction Sep/5/2020 U
NK:UNK NO
End Date Time:
Sep/9/2020 UNK:U
NK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  Right sided coronary artery
blockage Sep/5/2020 U
NK:UNK NO
End Date Time:
Sep/9/2020 UNK:U
NK
 Repeating
Pages
 3. ADVERSE
EVENT 3  Coronary Artery Disease  Sep/5/2020 U
NK:UNK YES  Repeating
Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022387
Page 41 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[STEMI: ST elevation Myocardial Infarction]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[undiagnosed Obstructive CAD]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022388
Page 42 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[2020365372]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022389
Page 43 of 220
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right sided coronary artery blockage ]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 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).YES
Is this serious event associated with congenital anomaly or birth defect?
Did this serious event result in death?
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
Is this serious event life threatening?
Other medically important serious event
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:
[CAD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022390
Page 44 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022391
Page 45 of 220
***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: 10951173 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)[Coronary Artery Disease]
4.Start Date Time: Sep/5/2020 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CAD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022392
Page 46 of 220
***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: 10951173 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[ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022393
Page 47 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022394
Page 48 of 220
***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: 10951173 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[ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022395
Page 49 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of MedicationStart D
ateForm Instan
ce
 1.1  VACCINATIO
NS NO  Influenza vaccine 1 dose IM once f
or influenza prevention Oct/28/
2020 Repeating
Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022396
Page 50 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influenza vaccine 1 dose IM once for influenza prevention]
5.Date: Oct/28/2020
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022397
Page 51 of 220
***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: 10951173 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
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022398
Page 52 of 220
***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: 10951173 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?
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022399
Page 53 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022400
Page 54 of 220
***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: 10951173 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?
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022401
Page 55 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022402
Page 56 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022403
Page 57 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022404
Page 58 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Feb/4/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022405
Page 59 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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/12/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 11:01
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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022406
Page 60 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022407
Page 61 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022408
Page 62 of 220
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022409
Page 63 of 220
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022410
Page 64 of 220
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022411
Page 65 of 220
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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 [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022412
Page 66 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022413
Page 67 of 220
***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: 10951173 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022414
Page 68 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022415
Page 69 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022416
Page 70 of 220
***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: 10951173 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: [ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022417
Page 71 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022418
Page 72 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Done Comments
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022419
Page 73 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022420
Page 74 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022421
Page 75 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022422
Page 76 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022423
Page 77 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022424
Page 78 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/5/2020
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022425
Page 79 of 220
***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: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022426
Page 80 of 220
***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: 10951173 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
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022427
Page 81 of 220
***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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-29-2020 14:24:53 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022428
Page 82 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022429
Page 83 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022430
Page 84 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022431
Page 85 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022432
Page 86 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022433
Page 87 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022434
Page 88 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022435
Page 89 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022436
Page 90 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022437
Page 91 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022438
Page 92 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
10Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022439
Page 93 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
11Oct-12-2020 09:50:03 (UTC-06:00) Central Time
(US & Canada)Due to SAE participant will remain in the study
without second vaccine.
Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022440
Page 94 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:54:34 (UTC-06:00) Central Time
(US & Canada)not done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022441
Page 95 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:52:43 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022442
Page 96 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-24-2021 10:52:43 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022443
Page 97 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormMar-03-2021 14:20:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormFeb-08-2021 10:53:27 (UTC-06:00) Central Time
(US & Canada)
FormFeb-04-2021 11:06:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022444
Page 98 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:53:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022445
Page 99 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-24-2021 10:53:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022446
Page 100 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-24-2021 10:53:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022447
Page 101 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-24-2021 10:53:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022448
Page 102 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-24-2021 10:53:00 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022449
Page 103 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:53:18 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022450
Page 104 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-24-2021 10:53:18 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022451
Page 105 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-24-2021 10:53:18 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022452
Page 106 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-24-2021 10:53:18 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022453
Page 107 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-24-2021 10:53:18 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022454
Page 108 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:53:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022455
Page 109 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-24-2021 10:53:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022456
Page 110 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-24-2021 10:53:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022457
Page 111 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-24-2021 10:53:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022458
Page 112 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-24-2021 10:53:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022459
Page 113 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022460
Page 114 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022461
Page 115 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022462
Page 116 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022463
Page 117 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022464
Page 118 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022465
Page 119 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022466
Page 120 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022467
Page 121 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022468
Page 122 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022469
Page 123 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
10Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022470
Page 124 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
11Feb-24-2021 10:54:08 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022471
Page 125 of 220
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-02-2021 17:11:04 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Nov-17-2020 19:54:27 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-14-2020 12:00:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Nov-14-2020 07:24:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-11-2020 09:45:54 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022472
Page 126 of 220
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
N/A
Paul Pickrell  Approved Nov-10-2020 21:20:36 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022473
Page 127 of 220
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-29-2020 14:23:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-29-2020 14:23:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022474
Page 128 of 220
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020 14:24:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/29/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022475
Page 129 of 220
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-03-2020 07:49:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-02-2020 07:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This has been updated
Sep-23-2020 04:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 2:'Coronary
artery occlusion' (onset
date:05SEP2020)is still
missing in AE CRF. Please
confirm and update
accordingly
Sep-22-2020 20:36:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed event added
Sep-22-2020 11:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this has been updated
Sep-22-2020 07:51:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered more information is
forthcoming
Sep-22-2020 05:10:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020365372R
sided coronary blockage
resulting in MI PT
Myocardial infarction' (onset
date:05SEP2020)was
reported as serious in Safety
database but missing in AE
CRF.Please confirm and
update CRF.If safety update
is required, submit a form
Sep-22-2020 05:10:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020365372R
sided coronary blockage
resulting in MI PT 'Coronary
artery occlusion(onset
date:05SEP2020)was
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022476
Page 130 of 220
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
reported as serious in Safety
database but missing in AE
CRF.Please confirm and
update CRF.If safety update
is required, submit a form
Aug-29-2020 14:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10951173Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020 14:23:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1971Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020 14:24:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-29-2020 14:24:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020 14:24:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASIANInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022477
Page 131 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 06:57:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-12-2020 08:25:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Participant is coming
in today.
Oct-12-2020 04:00:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Details on visit
‘V2VX2L’ are
missing. Kindly
consider to update or
else clarify. Thank
you.
Aug-29-2020 14:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022478
Page 132 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-29-2020 14:25:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020 14:25:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020 14:25:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022479
Page 133 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-29-2020 15:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:seasonal allerg
ies
Start Date: UNK/UNK/20
06
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-29-2020 15:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-29-2020 15:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-29-2020 15:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-29-2020 15:19:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022480
Page 134 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-29-2020 15:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:vasectomy
Start Date: UNK/UNK/201
4
Ongoing: NO
End Date:
UNK/UNK/2
014Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-29-2020 15:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-29-2020 15:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
vasectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-29-2020 15:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-29-2020 15:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022481
Page 135 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
87.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.4Initial Entry
7.a
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022482
Page 136 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020 14:25:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022483
Page 137 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020 15:18:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020 15:18:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
74020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022484
Page 138 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 14:26:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 14:26:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 17:55:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 01:53:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 14:26:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 14:26:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022485
Page 139 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-01-2020 17:55:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCT38Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 17:55:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPCT38Initial Entry
5.b
Date Location User Value Reason
Sep-01-2020 17:56:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCT39Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 17:56:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPCT39Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020 18:04:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2VRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 18:04:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2VRInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 18:04:51
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
Sample ID: BPY2VSInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1022486
Page 140 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US & Canada)
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 18:04:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2VSInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 18:05:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2VTInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 18:05:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2VTInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022487
Page 141 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 14:26:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 14:26:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 10:06:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 01:53:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 14:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 14:26:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022488
Page 142 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-01-2020 10:06:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BHMInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 10:06:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BHMInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022489
Page 143 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020 15:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022490
Page 144 of 220
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-29-2020 15:19:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022491
Page 145 of 220
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-29-2020 14:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022492
Page 146 of 220
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-15-2020
10:49:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3:
Closedbarcode has been
entered
Nov-14-2020
07:45:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3:
Reissued:
OpenedHold recon: Nasal
swab with barcode
BP1N5T received at
Lab; however
missing in database.
Please provide
missing data or else
update SCF.
Nov-13-2020
16:47:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3:
AnsweredPlease unfreeze and
requery
Nov-13-2020
03:04:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3:
OpenedHold recon: Nasal
swab with barcode
BP1N5T received at
Lab; however
missing in database.
Please provide
missing data or else
update SCF.
Oct-14-2020
00:19:41
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2:
ClosedAs per site
confirmation -
updated PD tracker
Oct-13-2020
09:16:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2:
AnsweredData is correct, due
to SAE visit out of
window
Oct-13-2020
05:09:29
(UTC-06:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 2:
OpenedPDQ: Date of visit at
V2_VAX2_L is out
of window for 21
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022493
Page 147 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Central Time
(US & Canada)days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately. 
Oct-12-2020
09:48:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Ent
ry:
Oct/12/20
20Initial Entry
Sep-27-2020
02:43:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies
query
Sep-25-2020
17:38:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1:
AnsweredThis pt has not come
in for visit yet. Will
complete once visit
occurs.
Sep-25-2020
05:48:06
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1:
OpenedDM: Kindly review
and complete ‘Date
of Visit, Nasal Swab,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022494
Page 148 of 220
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022495
Page 149 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-12-2020 09:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022496
Page 150 of 220
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 09:49:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 09:49:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-14-2020 12:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-14-2020 12:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Transcription Error
Nov-14-2020 12:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Sample
Collected?" is No,
but Barcodes are
present on the page.
Oct-14-2020 10:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-14-2020 09:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022497
Page 151 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
review and update as
appropriate.
Oct-14-2020 09:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-14-2020 09:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-13-2020 05:54:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-12-2020 09:49:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-12-2020 09:49:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-14-2020 10:41:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
No nasal swab or vaccine administe
red due to SAEInitial Entry
5.a
Date Location User Value Reason
Nov-14-2020 12:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1N5TInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022498
Page 152 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-14-2020 12:00:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1N5TInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022499
Page 153 of 220
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Route:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022500
Page 154 of 220
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-12-2020 09:50:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022501
Page 155 of 220
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020 09:47:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022502
Page 156 of 220
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 09:47:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 09:47:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 08:00:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-11-2020 11:42:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Please enter missing
barcodes or provide
date (or estimated
date) as to when the
missing information
is available. Please
provide DATE as to
when we can expect
the information.
Thank you!
Nov-11-2020 09:47:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-11-2020 09:47:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022503
Page 157 of 220
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a
Date Location User Value Reason
Nov-12-2020 08:00:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJWVInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 08:00:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJWVInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020 08:04:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDG1MInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 08:04:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRDG1MInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020 08:04:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDG1NInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 08:04:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRDG1NInitial Entry
5.d
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022504
Page 158 of 220
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-12-2020 08:04:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDG1PInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-12-2020 08:04:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRDG1PInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022505
Page 159 of 220
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 04:53:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-11-2020 13:56:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered This has been updated
Nov-11-2020 12:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM: Form is not
frozen. Please review
query and update as
appropriate.
Nov-11-2020 09:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/5/2020Transcription Error
Nov-11-2020 09:45:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered please unfreeze and
re-query so this can
be updated
Nov-10-2020 20:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened The discontinuation
date of 29AUG2020
should be relative to
the AE causing the
the withdrawal of the
study vaccine, AE
start 05SEP2020 and
end 09SEP2020 (date
should not be PRIOR
to start of AE). Please
adjust
Discontinuation da
Oct-30-2020 21:04:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020 14:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-29-2020 14:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/29/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022506
Page 160 of 220
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-26-2020 20:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical - End of
Treatment log CRF
would record the
subject's reason for
not receiving any
additional study drug
(ie no VAX 2). This is
separate from End of
Study, which is not
required here as
subject is continuing
in the study for
Followup.
Oct-21-2020 18:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please clarify EOT
reason as participant
is going to continue in
study just without
second vaccine.
Oct-21-2020 10:24:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical - SAE report
states subject elected
NOT to receive VAX
#2. If correct, please
complete the End of
Treatment
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 14:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-08-2020 09:52:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-06-2020 15:08:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Nov-06-2020 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022507
Page 161 of 220
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-06-2020 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered updated
Nov-06-2020 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTupdated
Nov-04-2020 05:14:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 4: Opened Action taken for the
SAE "STEMI: ST
elevation Myocardial
Infarction" is reported
as "DRUG
WITHDRAWN",
however status is
reported as
"OTHER". Please
verify and confirm
whether this needs to
be updated as
'Adverse event'. Else
clarify.
Nov-03-2020 06:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-02-2020 14:27:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered updated
Nov-02-2020 14:27:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-02-2020 14:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is OTHER but
"Specify Status" is
missing.
Nov-02-2020 14:26:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERupdated
Nov-01-2020 04:48:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM 1: There is no
Adverse Event with
'Did the adverse event
cause the subject to be
discontinued from the
study' reported as
YES. Please recheck
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022508
Page 162 of 220
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
and update AE page
accordingly, else
clarify.
Oct-30-2020 15:25:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Per CRM, participant
will remain in the
study although he
chooses to not receive
the second vaccine.
Oct-30-2020 00:04:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM : Status is
recorded as
ADVERSE EVENT.
However, Response to
Did the adverse event
cause the subject to be
discontinued from the
study? Is not recorded
as YES on AE Log
page. Please review
and update. Else,
clarify.
Oct-29-2020 14:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 14:21:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Participant is not
discontinuing from
study only from
second vaccine.
Please clarify if this
should be answered
dif.
Oct-29-2020 14:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Oct-29-2020 14:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022509
Page 163 of 220
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-29-2020 14:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-06-2020 15:08:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: updated as requested
Nov-02-2020 14:27:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is choosing to not receiv
e 2nd vaccine, per CRM, participan
t is okay to continue in studInitial Entry
Oct-29-2020 14:22:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: updated
Oct-29-2020 14:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Patient to continue without second
vaccineInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022510
Page 164 of 220
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022511
Page 165 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-12-2020 13:28:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022512
Page 166 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022513
Page 167 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020
17:33:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clos
edResponse satisfies query
Oct-13-2020
15:16:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Ans
weredChanged Information
Oct-13-2020
15:16:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
STEMI
: ST ele
vation
Myocar
dial Inf
arctionChanged Information
Oct-13-2020
10:41:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Open
edCLINICAL recent SAE safety
update changed the event term to
STEMI; please harmonize the
event term on the AE CRF
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022514
Page 168 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-28-2020
05:01:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clos
edResponse satisfies query
Sep-26-2020
00:30:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Clos
edDiscrepancy has been closed.
Sep-25-2020
17:31:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Ans
weredupdated
Sep-25-2020
17:31:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredupdated
Sep-25-2020
17:31:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Myocar
dial Inf
arctionupdated
Sep-25-2020
07:17:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Open
edSAE
RECON:AER#2020365372,term
was updated to MYOCARDIAL
INFARCTION in Safety
database while retained as 'Right
sided coronary blockage
resulting in Myocardial
Infarction'in AE CRF.Please
confirm.If safety update is
required, please submit a
follow-up form
Sep-24-2020
10:04:53
(UTC-06:00)
Central TimeACV0PFEINFP6000  Quan Jason
GongQuery
1: Clos
edThis will be addressed by the
response to a separate query
which requesting coronary
blockage and MI to be listed as
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022515
Page 169 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US &
Canada)2 separate events.
Sep-24-2020
00:42:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Open
edMultiple concepts in the term
RIGHT SIDED CORONARY
BLOCKAGE RESULTING IN
MYOCARDIAL
INFARCTION. Split the term
into RIGHT SIDED
CORONARY BLOCKAGE and
MYOCARDIAL INFARCTION
and submit separately. Thank
you.
Sep-23-2020
18:42:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-23-2020
18:42:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Right si
ded cor
onary b
lockage
resultin
g in My
ocardia
l Infarct
ionTranscription Error
Sep-23-2020
15:14:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery
1: Open
edGPDClin: The SAE reporting
term "right sided coronary
blockage resulting in myocardial
infarction (MI)" includes 2
SAEs. Please add "right sided
coronary blockage" as a separate
SAE.
Sep-22-2020
11:26:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Myocar
dial Inf
arctionTranscription Error
Sep-22-2020
11:24:23
(UTC-06:00)ACV0PFEINFP6000  Data E
ntry:
UndiagTranscription Error
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022516
Page 170 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Central Time
(US &
Canada)nosed o
bstructi
ve CA
D causi
ng Myo
cardial
Infarcti
on
Sep-22-2020
07:50:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
Myocar
dial Inf
arctionInitial Entry
4. Start Date Time:
Date Location User ValueReason
Nov-11-2020
09:23:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Nov-10-2020
17:39:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredPlease unfreeze and
requery/date will be entered
as 21SEP2020
Nov-10-2020
15:01:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dThe status date on EOT
should be the date when the
subject was withdrawn from
the treatment, therefore
equal to or after the AE start
date since drug was
withdrawn due to this AE.
Nov-10-2020
13:40:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredThe date of completion is
representing last treatment
received. Please advise on
how to enter this if this is
incorrect. Participant
received 1 injection and
prior to vaccine 2 had an
MI. Participant is choosing
to not receive 2nd vaccine.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022517
Page 171 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-09-2020
05:40:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW5308222;The Latest
Action to Study Treatment
is DRUG WITHDRAWN,
but the Start Date of this AE
is AFTER the Date of
Completion/Discontinuation
/Death on Disposition-
Treatment Form. Please
review and update as
appropriate.
Nov-02-2020
19:41:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_AE001_33
Nov-02-2020
00:22:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM : Date of
Completion/Discontinuation
/Death (29/Aug/2020) on
EOT is prior to AE start
date (5/Sep/2020). Please
review and update. Else,
clarify.
Oct-30-2020
13:23:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredPlease clarify if you would
like the date to be last date
of vaccine (being vaccine 1)
or date of second visit,
although no vaccine took
place. Please advise.
Oct-30-2020
02:41:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5223299;The Latest
Action to Study Treatment
is DRUG WITHDRAWN,
but the Start Date of this AE
is AFTER the Date of
Completion/Discontinuation
/Death on Disposition-
Treatment Form. Please
review and update as
appropriate.
Sep-22-2020
07:50:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Sep/5/
2020
UNK:
UNKInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022518
Page 172 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-22-2020 11:31:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/9/2020 UNK:UNKNew Information
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-22-2020 11:26:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
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).
Date Location User Value Reason
Mar-04-2021 01:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 5: Closed Response satisfies
query
Mar-03-2021 15:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered EDC updated, SAE
will be updated and
sent
Mar-03-2021 15:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NOEDC updated, SAE
will be updated and
sent
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022519
Page 173 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
YES
Other medically important seriou
s event
NO
Mar-02-2021 20:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 5: Opened GPDClin: The SAE
was considered Grade
4, meaning
life-threatening, so
please check that
criterion "Yes".
Alternatively, if it was
not life-threatening,
then change the grade
to 3 or lower.
Nov-10-2020 22:41:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID test
info
Nov-10-2020 17:44:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered This has been updated
and will be
resubmitted.
Oct-30-2020 19:17:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020365372] to
provide whether
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022520
Page 174 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
COVID testing was
performed (yes/no)
and if yes, the results.
Oct-30-2020 03:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Data amended
Oct-29-2020 14:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Transcription Error
Oct-29-2020 14:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-29-2020 14:23:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
NOTranscription Error
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022521
Page 175 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-29-2020 13:31:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 4: Opened Only the seriousness
criteria "Did this
serious event require
or prolong
hospitalization?" is
answered, all other
serious criterias are
left blank. Please
answer all seriousness
criteria questions with
"Yes" or "No"
response. Thank you.
Oct-21-2020 10:26:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020365372] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Sep-23-2020 02:48:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-22-2020 20:37:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 11:27:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered updated
Sep-22-2020 11:26:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require or
prolong hospitalization?
YES
Is this serious event life threateni
ng?Transcription Error
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022522
Page 176 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
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).
Date Location User Value Reason
Sep-22-2020 11:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Myocardial
Infarction: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-22-2020 11:25:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require or
prolong hospitalization?
YES
Is this serious event life threateni
ng?
YESTranscription Error
Sep-22-2020 11:24:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Undiagnosed
obstructive CAD
causing Myocardial
Infarction: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-22-2020 07:50:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please
review and update as
appropriate.
Sep-22-2020 07:50:18 ACV0PFEINFP6000  auto query Query 1: Candidate For AE Myocardial
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022523
Page 177 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)(autoquery) Infarction: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-22-2020 07:50:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require or
prolong hospitalization?
YESInitial Entry
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.
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-08-2020
21:57:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Katherine Puig Query 1: Clos
edCaptured under
AE2
Oct-06-2020
08:16:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredPlease clarify -
All data
collected has
been entered.
Oct-03-2020
01:25:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Ope
nedPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field
[Obstructive
CAD]. Any
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022524
Page 178 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. If this is
already in the
predefined list
above please
choose the
appropriate
value. Please
review and
update as
necessary.
Sep-22-2020
11:25:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELAT
ED
If Not Relat
ed to study t
reatment(s),
this event is
due to:
OTHER
If Other,
specify:
undiagn
osed O
bstructi
ve CA
DInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
13:38:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Answered New Information
Mar-12-2021
13:38:09
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOT APPLICABLENew Information
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022525
Page 179 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
Mar-12-2021
02:49:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 6: Reissued:Opene
dSAE RECON: Form is now
unfrozen. Please update per query
response below.
Mar-11-2021
08:09:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 6: Answered BECAUSE THE PARTICIPANT
DECIDED TO RECEIVE THE
SECOND VACCINE THIS
INFORMATION WAS
CHANGED. PLEASE
UNFREEZE SO THAT I CAN
CORRECT.
Mar-11-2021
04:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 6: Opened SAE
RECON:AER#2020365372 ,action
taken was updated to DRUG
WITHDRAWN in AE CRF.Per
PSSR confirmation, action
reported was NOT APPLICABLE
in SAE FORM.Please confirm
correct outcome.
Nov-18-2020
13:01:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed updated in safety
Nov-18-2020
10:28:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered This will be updated if directed to
do so by ICON. I have a call in
and will wait for reply. EDC data
is correct.
Nov-14-2020
09:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opene
dSAE RECON 2: Please submit a
follow up SAE form to Pfizer
safety to update action taken in
Safety database to Drug
withdrawn to match Inform action
taken.
Nov-13-2020
16:38:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Please clarify what is meant by
AEM
Nov-13-2020
05:31:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opene
dSAE RECON 1:Per Clinical,based
on decision, the event should be
withdrawn in safety as the second
vax was not given.A follow up
AEM form is required to update
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022526
Page 180 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
action taken in Safety
database.Please confirm and
submit form and indicate correct
action taken
Nov-11-2020
01:22:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Candi
dateFor Clinical review
Nov-10-2020
13:36:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Technically drug is not
withdrawn, however participant is
requesting to not receive. Per
sponsor participant can continue
in the study.
Nov-10-2020
10:05:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Response satisfies query
Nov-04-2020
02:04:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened Clinical The reported action taken
with study drug is withdrawn for
AE (as reported under the AE);
however End of Treatment does
NOT state study drug was
withdrawn for AE. Please review
and harmonize the AE/Study drug
reporting in AE/SAE/EOT
Nov-04-2020
01:54:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Candidate Clinical The reported action taken
with study drug is withdrawn for
AE (as reported under the AE);
however End of Treatment does
NOT state study drug was
withdrawn for AE. Please review
and harmonize the AE/Study drug
reporting in AE/SAE/EOT
Oct-30-2020 19:19:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Oct-30-2020 06:40:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE
RECON:AER#2020365372 ,action
taken was updated to DRUG
WITHDRAWN in AE CRF while
retained as Not applicable in
Safety database.Please confirm if
a follow up AEM form was sent
to update action taken in Safety
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022527
Page 181 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
database.
Oct-29-2020 14:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-29-2020 14:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNTranscription Error
Oct-27-2020 09:23:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opene
dCLINICAL Unfrozen. Per SAE
report, Decision was now made to
not administer VAX2. Per CRF
Completion Guide 8.50.9: For this
study: DRUG WITHDRAWN
should be selected if the second
vaccination dose was not
administered due to the AE.
Oct-23-2020 18:12:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Please unfreeze and requery
Oct-22-2020 12:10:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL Per SAE report,
Decision was now made to not
administer VAX2. Per CRF
Completion Guide 8.50.9: For this
study: DRUG WITHDRAWN
should be selected if the second
vaccination dose was not
administered due to the AE.
Oct-22-2020 12:09:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed closed to add completion
guidelines section
Oct-22-2020 12:04:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL Per SAE report,
Decision was made to not
administer VAX2. Please update
last action taken with study
treatment.
Oct-08-2020 10:59:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-06-2020 08:14:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered updated - participant will be given
the option to move forward with
second vaccine or discontinue
vaccine. Attempts have been
made to reach participant have
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022528
Page 182 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
been unsuccessful.
Oct-06-2020 08:14:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEupdated - participant will be given
the option to move forward with
second vaccine or discontinue
vaccine. Attempts have been
made to reach participant have
been unsuccessful.
Sep-29-2020 09:50:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY If study drug is
withdrawn for this AE, please
complete the End of Treatment
CRF
Sep-22-2020 07:50:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-22-2020 07:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-22-2020 11:31:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 11:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Myocardial
Infarction: Response
to "What was the
outcome of this
adverse event?" is 3
but End Date/Time is
missing.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022529
Page 183 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-22-2020 11:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDChanged
Information
Sep-22-2020 07:50:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 10:15:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-23-2020 08:58:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-23-2020 08:58:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Sep-23-2020 00:41:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Did the adverse
event cause the
subject to be
discontinued from
the study?" is
missing. Kindly
review and update.
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022530
Page 184 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-22-2020 20:37:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020365372Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022531
Page 185 of 220
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-11-2020 19:30:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-06-2020 14:02:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered drug withdrawal
marked in error.
Oct-05-2020 20:36:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Right
sided coronary artery
blockage: Noted
drug withdrawal on
AE CRF but no
Disposition
Treatment form. If
the Participant does
not complete the
treatment period,
select the status
accordingly (CCR
section 8.55).
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right sided coronary artery blocka
geInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022532
Page 186 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
4. Start Date Time:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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).
Date Location User Value Reason
Oct-12-2020 14:33:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Data was deleted.
Oct-12-2020 13:28:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered will delete
Oct-07-2020 05:39:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1:The
term in Safety
database was updated
to Myocardial
Infarction which
matches AE#1 hence,
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022533
Page 187 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
right sided coronary
artery blockage was
not captured. If event
should be added as
separate AE in SDB,
submit a follow up
form.
Oct-06-2020 16:57:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered An SAE has been
submitted for this. If
you are looking for
something else,
please clarify.
Oct-03-2020 07:19:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:Right
sided coronary artery
blockage(Onset
date:05Sep2020) is
not reported to Safety
database but marked
serious on AE
CRF.Please confirm if
event should be
added in SDB as
separate SAE.If this
event is not serious,
downgrade the event
on AE CRF
Oct-02-2020 09:50:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-02-2020 07:53:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered prolonged
hospitalization
required is marked as
YES
Oct-02-2020 07:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please
review and update as
appropriate.
Oct-02-2020 07:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Right sided
coronary artery
blockage: Response
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022534
Page 188 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-02-2020 07:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require o
r prolong hospitalization?
YESInitial Entry
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.
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
CADInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-06-2020 16:27:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Oct-06-2020 14:01:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022535
Page 189 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-06-2020 14:01:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLETranscription Error
Oct-06-2020 13:53:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY:
DRUG
WITHDRAWN is
reported for this
adverse event. If this
is correct that subject
will not receive Vax2,
then please complete
the EOT page to
indicate end of
treatment.
Oct-02-2020 07:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-02-2020 07:52:31
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1022536
Page 190 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
(US & Canada)
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022537
Page 191 of 220
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery DiseaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022538
Page 192 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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).
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
CADInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 11:18:14 ACV0PFEINFP6000  Quan Jason Query 1: Closed Response satisfies
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022539
Page 193 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Gong query
Mar-09-2021 09:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-09-2021 09:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Mar-02-2021 20:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if any
medication was
given. If yes, please
change to "Yes" here.
Nov-16-2020 18:10:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 18:10:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022540
Page 194 of 220
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Nov-11-2020 09:46:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022541
Page 195 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-11-2020 09:46:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-11-2020 09:46:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-11-2020 09:46:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-12-2020
01:04:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Nov-11-2020
15:04:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edTranscription
Error
Nov-11-2020
15:04:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Influenza vaccine
1 dose IM once f
or influenza prev
entionTranscription
Error
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022542
Page 196 of 220
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail 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: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Nov-11-2020
14:09:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify
INFLUENZA
VACCINE 1
DOSE UN ONCE
FOR
INFLUENZA
PREVENTION as
follows¿Please
spell out the
abbreviation UN.
If reporting
INFLUENZA
VACCINE 1
DOSE IN ONCE
FOR
INFLUENZA
PREVENTION
update the
verbatim term as
such. Otherwise
clarify and update
the term as
appropriate or
provide
reference/label.
Thank you.
Nov-11-2020
09:46:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Influenza vaccine
1 dose UN once f
or influenza prev
entionInitial Entry
5. Date:
Date Location User Value Reason
Nov-11-2020 09:46:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022543
Page 197 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 16:39:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022544
Page 198 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2.a
Date Location User Value Reason
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1022545
Page 199 of 220
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Feb-25-2021 16:40:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022546
Page 200 of 220
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Oct/12/2020
Reason(s) for Temporary Delay of
Vaccination
FEVER OR ACUTE ILLNESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021 11:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022547
Page 201 of 220
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-25-2021 16:41:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022548
Page 202 of 220
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 23:13:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 15:57:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered uploaded consent
with coordinator
signature.
Feb-24-2021 20:06:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Person obtaining
consent signature is
not on ICF V6.0,
instead the subject
signed. It is either
because Pg 20 not
uploaded properly or
subjects signed.
Please re-upload or
correct the error,
thanks
Feb-02-2021 17:11:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022549
Page 203 of 220
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-08-2021 10:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Transcription Error
Feb-02-2021 17:11:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national recom
mendations and confirmed to ha
ve received only placebo at Vac
cination 1/2Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022550
Page 204 of 220
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-02-2021 17:11:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-02-2021 17:11:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022551
Page 205 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 02:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-03-2021 14:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This has been added
Feb-26-2021 05:38:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: REVAX IE
form has been
unfrozen. Please
update.
Feb-25-2021 14:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered unfreeze& requery
please.
Feb-25-2021 05:28:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM2: Thank you
for response. Kindly
confirm if visit is
erroneous visit if
yes add form level
comment as Not
Applicable on
REVAX IE form of
this visit by
referring CCG
section 4.10. Else
clarify.
Feb-24-2021 10:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered data updated
Feb-10-2021 03:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you
for your reply.
However, form level
comment is not
present on rest for
forms. Kindly
consider to add form
level comment by
selecting Not Done
or Not Applicable
option on rest of
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022552
Page 206 of 220
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
forms or else clarify.
Feb-09-2021 16:26:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirm visit was
erroneous and did
not occur.
Feb-09-2021 04:52:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Erroneous visit
is marked. Please
confirm if this visit
occurred. If yes,
kindly untick
erroneous visit
button. If entered in
error, kindly mark
the rest of forms as
Not Done or Not
Applicable at form
level comment or
else clarify.
Feb-08-2021 10:52:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Feb-04-2021 11:06:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-08-2021 10:52:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022553
Page 207 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-24-2021 10:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-08-2021 10:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-04-2021 11:06:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/4/2021Initial Entry
090177e196ae2fb5\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1022554
Page 208 of 220
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-24-2021 10:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-08-2021 10:53:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-04-2021 11:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-24-2021 10:53:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Feb-08-2021 10:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEI
…[truncated]