125742 S1 M5 CRF c4591001 1095 10951107

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
214
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021598
Page 2 of 214
***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: 10951107 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/7/2020
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021599
Page 3 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951107]
2.Birth Date: 1938
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021600
Page 4 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021601
Page 5 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021602
Page 6 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021603
Page 7 of 214
***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: 10951107 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:[Coronary artery disease]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes mellitus Type 2]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hepatitis A]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021604
Page 8 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Irritable Bowel Syndrome]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/2016
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary stents Insertion (3)]
Start Date: UNK/UNK/1995
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Thyroidectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021605
Page 9 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eastern Equine Encephalitis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Traumatic Stress Disorder]
Start Date: UNK/UNK/1995
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Mild cellulitis (right arm)]
Start Date: Mar/UNK/2020
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Muscle strain (left arm)]
Start Date: Jul/31/2020
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021606
Page 10 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperthyroidism]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pacemaker Implant]
Start Date: Dec/23/2019
Ongoing: NO
End Date:
Dec/23/2019
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pacemaker Explant]
Start Date: Jul/24/2020
Ongoing: NO
End Date:
Jul/24/2020
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: Jul/15/2020
Ongoing: YES
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021607
Page 11 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [103.8]
3.Unit: kg
4.Height: [180.0]
5.Unit: cm
6.Body Mass Index: [32.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021608
Page 12 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [224438]
3.Randomization Group: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021609
Page 13 of 214
***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: 10951107 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/7/2020
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 [BP3BY2]
5.bSample ID [BP3BY3]
5.cSample ID [BP3BY4]
5.dSample ID [BPLJJR]
5.eSample ID [BPLJJS]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021610
Page 14 of 214
***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: 10951107 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/7/2020
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 [BP3BB8]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021611
Page 15 of 214
***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: 10951107 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/7/2020 17:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021612
Page 16 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021613
Page 17 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021614
Page 18 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021615
Page 19 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021616
Page 20 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021617
Page 21 of 214
***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: 10951107 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/27/2020
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 [BP3BG5]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021618
Page 22 of 214
***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: 10951107 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/27/2020 15:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021619
Page 23 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021620
Page 24 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021621
Page 25 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021622
Page 26 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BPY2MW]
5.bSample ID [BPY2MX]
5.cSample ID [BPY2MY]
5.dSample ID [BPCTCJ]
5.eSample ID [BPCTCK]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021623
Page 27 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021624
Page 28 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021625
Page 29 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021626
Page 30 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021627
Page 31 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021628
Page 32 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021629
Page 33 of 214
***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: 10951107 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:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021630
Page 34 of 214
***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: 10951107 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: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021631
Page 35 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021632
Page 36 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021633
Page 37 of 214
***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: 10951107 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?
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021634
Page 38 of 214
***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: 10951107 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:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021635
Page 39 of 214
***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: 10951107 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:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021636
Page 40 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021637
Page 41 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021638
Page 42 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021639
Page 43 of 214
***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: 10951107 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021640
Page 44 of 214
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/28/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [due to ongoing medical issues]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021641
Page 45 of 214
***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: 10951107 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:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021642
Page 46 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021643
Page 47 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Hypoglycemia  Aug/12/2020 12:
00 NO
End Date Time:
Aug/12/2020 13:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  Dizziness, secondary to Cloni
dine reaction Aug/31/2020 16:
00 NO
End Date Time:
Sep/2/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE E
VENT 3  Suspected tachy-arrythmia  Sep/8/2020 UNK
:UNK NO
End Date Time:
Sep/22/2020 UNK:UN
K
 Repeating
Pages
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021644
Page 48 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 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)[Hypoglycemia]
4.Start Date Time: Aug/12/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/12/2020 13:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hypoglycemia, on insulin, is type II diabetic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021645
Page 49 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021646
Page 50 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness, secondary to Clonidine reaction]
4.Start Date Time: Aug/31/2020 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/2/2020 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?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021647
Page 51 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 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?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020339734]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021648
Page 52 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 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)[Suspected tachy-arrythmia]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/22/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021649
Page 53 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[underlying cardiac condition likely requiring pacemaker]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES Comments
12.Was a Non-Drug Treatment given? NO Comments
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[2020353828]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021650
Page 54 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021651
Page 55 of 214
***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: 10951107 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[ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021652
Page 56 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021653
Page 57 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021654
Page 58 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021655
Page 59 of 214
***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: 10951107 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?
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021656
Page 60 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021657
Page 61 of 214
***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: 10951107 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?
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021658
Page 62 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021659
Page 63 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021660
Page 64 of 214
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021661
Page 65 of 214
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021662
Page 66 of 214
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021663
Page 67 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021664
Page 68 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021665
Page 69 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021666
Page 70 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021667
Page 71 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021668
Page 72 of 214
***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: 10951107 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 [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021669
Page 73 of 214
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021670
Page 74 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021671
Page 75 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021672
Page 76 of 214
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/28/2020
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021673
Page 77 of 214
***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: 10951107 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: [ ]
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021674
Page 78 of 214
***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: 10951107 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/28/2020
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021675
Page 79 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021676
Page 80 of 214
***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: 10951107 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
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021677
Page 81 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-13-2020 13:48:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021678
Page 82 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
11Nov-16-2020 11:47:05 (UTC-06:00) Central Time
(US & Canada)
11Sep-11-2020 17:35:03 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021679
Page 83 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
12Nov-16-2020 11:45:25 (UTC-06:00) Central Time
(US & Canada)
12Sep-11-2020 17:37:32 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021680
Page 84 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormMar-11-2021 10:48:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021681
Page 85 of 214
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Mar-11-2021 10:48:00 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021682
Page 86 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormMar-11-2021 10:50:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021683
Page 87 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Mar-11-2021 10:50:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021684
Page 88 of 214
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Mar-11-2021 10:50:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021685
Page 89 of 214
***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: 10951107 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-23-2021 16:33:00 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Nov-17-2020 19:50:39 (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-16-2020 11:45:25 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Oct-30-2020 15:32:47 (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 Oct-27-2020 18:48:47 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021686
Page 90 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
N/A
Paul Pickrell  Approved Oct-23-2020 18:58:18 (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 Oct-23-2020 17:54:36 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Oct-14-2020 07:43:30 (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 Sep-28-2020 17:18:55 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Sep-22-2020 17:10:34 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021687
Page 91 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021688
Page 92 of 214
***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: 10951107 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-07-2020 18:13:25
(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-07-2020 18:13:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021689
Page 93 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020 18:13:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/7/2020Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021690
Page 94 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020 18:13:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10951107Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020 18:13:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1938Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020 18:13:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-07-2020 18:13:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020 18:13:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021691
Page 95 of 214
***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: 10951107 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-09-2020 04:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-06-2020 16:00:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered I have spoken with our
CRA and we are not
comfortable with
making this change as
when we screened this
participant
inclusion/exclusion
was met.
Nov-02-2020 04:16:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened ClinQuery: many
thanks for this
information, I
appreciate that the
subject did not
disclose their history,
but as it is now known
please update the
inc/ex to reflect the
data that is now
available.
Oct-30-2020 14:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered If participant had been
a reliable historian
then indeed,
participant would have
been a screen fail.
Participant did not
disclose this
information until
already enrolled in the
study.
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: a deviation
has been written that
indicates Pacemaker
explant and new
ConMeds for
hypertension occurred
within 1 day to 3
weeks prior vax 1.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021692
Page 96 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Please consider if
subject meets
Inclusion criteria 3
(stable subject) and
update eligibility as
needed
Aug-14-2020 01:28:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM
Aug-13-2020 13:49:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This has been updated
Aug-13-2020 01:41:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Inclusion/Exclusion
criteria have been
added, vaccination
details present.
Inclusion/Exclusion is
expected only for
Screen Failure and
subjects randomized in
error. Please add Form
level comment “Not
Applicable” if
Incl/Excl was added in
error or confirm.
Aug-07-2020 18:13:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-1021693
Page 97 of 214
***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: 10951107 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-07-2020 18:14:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020 18:14:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020 18:14:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021694
Page 98 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020 18:14:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Coronary artery d
isease
Start Date: UNK/UNK/2013
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:14:48
(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
Sep-22-2020 21:22:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Wait for further
information from site.
Sep-11-2020 13:31:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened GPDClin: Please
reconcile the start
date of CAD 2013
with cardiac stent
since 1995. If
appropriate, please
revise CAD start to
1995.
Aug-11-2020 07:50:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-10-2020 18:32:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Placement due to
original diagnosis of
Angina. Per PI,
coronary Artery
Disease is more likely
correct diagnosis.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021695
Page 99 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-10-2020 16:54:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please confirm the
start date (year) of
this condition. The
current entry of
"2013" seems conflict
with the other
medical history item
of "coronary stents"
placement in 1995.
Aug-07-2020 18:14:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary artery diseaseInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-07-2020 18:14:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020 18:14:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-07-2020 18:15:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Diabetes mellitus
Type 2
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021696
Page 100 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:15:18
(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-07-2020 18:15:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes mellitus Type 2Initial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020 18:15:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-07-2020 18:15:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-07-2020 18:15:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hepatitis A
Start Date: UNK/UNK/196
5
Ongoing: NO
End Date:
UNK/UNK/1
965Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021697
Page 101 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:15:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:15:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hepatitis AInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-07-2020 18:15:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-07-2020 18:15:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Initial Entry
1.d
Date Location User Value Reason
Aug-07-2020 18:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History T
erm:Hypercholesterol
emia
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021698
Page 102 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-07-2020 18:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-07-2020 18:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-07-2020 18:16:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021699
Page 103 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:16:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 08:26:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-10-2020 14:40:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Per above query,
ongoing diagnosis,
not a new diagnosis
just a change in
therapy, no clinical
symptoms
Sep-03-2020 14:02:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per the
SAE report, the
participant started
clonidine and
hydralazine for this
condition started 1
day and 3 weeks
prior to the 1st study
dose. Please provide
assessment for
inclusion criterion 3-
stable disease in the
past 6 weeks and
rationale.
Aug-07-2020 18:16:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-07-2020 18:16:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021700
Page 104 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-07-2020 18:16:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-07-2020 18:17:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Irritable Bowel Sy
ndrome
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:17:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:17:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Irritable Bowel SyndromeInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-07-2020 18:17:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-07-2020 18:17:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021701
Page 105 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.g
Date Location User Value Reason
Aug-07-2020 18:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Sleep apnea
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sleep apneaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-07-2020 18:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-07-2020 18:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-10-2020 18:28:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num 8Transcription Error
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021702
Page 106 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
ber:
Medical Histor
y Term:Coronary stents Ins
ertion (3)
Start Date: UNK/UNK/1995
Ongoing: YES
Aug-07-2020 18:18:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Coronary stent
s
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021703
Page 107 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.h Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:18:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
08:20:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Aug-10-2020
18:28:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription Error
Aug-10-2020
18:28:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Coronary stents
Insertion (3)Transcription Error
Aug-07-2020
19:45:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opene
dClarify
CORONARY
STENTS as
follows...Are you
reporting
CORONARY
STENTS
INSERTION?
CORONARY
STENTS
REMOVAL?
OCCLUSION?
COMPLICATION?
If so, please edit as
such. Otherwise,
specify the term
further. Thank you.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021704
Page 108 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:18:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary stentsInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-07-2020 18:18:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-07-2020 18:18:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-07-2020 18:18:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:Thyroidectomy
Start Date: UNK/UNK/200
9
Ongoing: NO
End Date:
UNK/UNK/2
009Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021705
Page 109 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.i Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:18:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 07:29:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-10-2020 18:45:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirmed with
patient via phone call.
Subject confirmed
Hypothyroidism and
information was
added to medical
history.
Aug-10-2020 16:58:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please add the
corresponding medical
condition for this
procedure as a
separate medical
history item.
Aug-07-2020 18:18:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ThyroidectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-07-2020 18:18:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-07-2020 18:18:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021706
Page 110 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.j
Date Location User Value Reason
Aug-10-2020 18:23:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Eastern Equine En
cephalitis
Start Date: UNK/UNK/2010
Ongoing: YESTranscription Error
Aug-07-2020 18:19:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:East Nile Viru
s
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021707
Page 111 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.j Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:19:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
18:19:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Response satisfies
query
Aug-11-2020
14:42:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answer
edParticipant is
stable but
continues to
complain of
physical effects of
the disease.
Aug-11-2020
08:20:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Aug-11-2020
08:20:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Reissue
d:OpenedEastern Equine
Encephalitis is
very rare and
deadly disease.
You indicated the
condition is still
ongoing. please
clarify if the
participant is still
suffering ongoing
neurologic
problems.
Aug-10-2020
18:23:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answer
edTranscription
Error
Aug-10-2020 ACV0PFEINFP6000  auto query Query 1: Answer Transcription
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021708
Page 112 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
18:23:36
(UTC-06:00)
Central Time (US
& Canada)(autoquery) ed Error
Aug-10-2020
18:23:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Eastern Equine E
ncephalitisTranscription
Error
Aug-10-2020
16:57:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened In addition to the
query to confirm
the term, please
also clarify if it is
still present as
West Nile Virus
infection is not
commonly a
chronic disease.
Aug-07-2020
20:39:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify EAST
NILE VIRUS as
follows...Clarify
EAST. Are you
reporting WEST
NILE VIRUS?
Other? Please
update the
verbatim term to
clarify organism
only reported.
Please clarify if
reporting TEST or
TEST POSITIVE
or INFECTION or
other and update
the verbatim term
accordingly.
Thank you.
Aug-07-2020
18:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
East Nile VirusInitial Entry
1.j Start Date:
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021709
Page 113 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-07-2020 18:19:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-07-2020 18:19:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-07-2020 18:19:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Post Traumatic Stre
ss Disorder
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021710
Page 114 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.k Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:19:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:19:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Post Traumatic Stress DisorderInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-07-2020 18:19:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-07-2020 18:19:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-07-2020 18:20:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:Mild cellulitis (rig
ht arm)
Start Date: Mar/UNK/2020
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021711
Page 115 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.l Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:20:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 07:43:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-10-2020 18:34:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject is taking
Linezolid. 600 mg
BID. Taking since
17JUL2020
Aug-10-2020 17:02:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please clarify if the
condition has lasted
for $+ months since
Mar 2020 and still
present. Has there
been any treatment
given?
Aug-07-2020 18:20:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mild cellulitis (right arm)Initial Entry
1.l Start Date:
Date Location User Value Reason
Aug-07-2020 18:20:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2020Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-07-2020 18:20:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021712
Page 116 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-07-2020 18:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:Muscle strain (lef
t arm)
Start Date: Jul/31/2020
Ongoing: YESInitial Entry
1.m Line/MH Number:
Date Location User Value Reason
Aug-07-2020 18:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-07-2020 18:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Muscle strain (left arm)Initial Entry
1.m Start Date:
Date Location User Value Reason
Aug-07-2020 18:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-07-2020 18:20:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-11-2020 14:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:14
Medical History T
erm:Hypothyroidi
smTranscription Error
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021713
Page 117 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Start Date: UNK/UNK/2
009
Ongoing: YES
Aug-10-2020 18:44:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical History
Term:Hypothyroidis
m
Start Date: UNK/UNK/20
09
Ongoing: NO
End Date:
UNK/UNK/
2009Initial Entry
1.n Line/MH Number:
Date Location User Value Reason
Aug-10-2020 18:44:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 18:20:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-11-2020 14:41:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated
Aug-11-2020 08:09:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Typically,
hypothyroidism is the
result of
thyroidectomy, not
the cause. On the
other hand,
hyperthyroidism can
be the cause of
thyroidectomy. Please
clarify. Thank you.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021714
Page 118 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 18:44:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-10-2020 18:44:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-11-2020 14:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Aug-10-2020 18:44:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.o
Date Location User Value Reason
Aug-11-2020 14:40:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:15
Medical History T
erm:hyperthyroidism
Start Date: UNK/UNK/200
9
Ongoing: NO
End Date:
UNK/UNK/2
009Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1021715
Page 119 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.o Line/MH Number:
Date Location User Value Reason
Aug-11-2020 14:40:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 14:40:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hyperthyroidismInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-11-2020 14:40:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-11-2020 14:40:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.p
Date Location User Value Reason
Sep-09-2020 17:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History T
erm:Pacemaker Impl
ant
Start Date: Dec/23/2019
Ongoing: NO
End Date:
Dec/23/2019Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021716
Page 120 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.p Line/MH Number:
Date Location User Value Reason
Sep-09-2020 17:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-09-2020 17:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Pacemaker ImplantInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-09-2020 17:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/23/2019Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-09-2020 17:21:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/23/2019Initial Entry
1.q
Date Location User Value Reason
Sep-09-2020 17:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History T
erm:Pacemaker Expl
ant
Start Date: Jul/24/2020
Ongoing: NO
End Date:
Jul/24/2020Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021717
Page 121 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.q Line/MH Number:
Date Location User Value Reason
Sep-09-2020 17:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 08:25:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-10-2020 14:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered 1) PI believes this is
from an unstable
rhythm. Explant due
to body rejection of
the pacemaker
according to the pt. If
information would
have been reported by
pt at visit one, this
participant would not
have been enrolled.
Sep-09-2020 22:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Appreciate
the info that
pacemaker
implant/explant were
not reported by the
subject Visit 1. 1)
Please further obtain
the reason for those
procedures; 2) please
get PI' assessment
against Inclusion #3
(retrospectively
though).
Sep-09-2020 17:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Pacemaker ExplantInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-09-2020 17:23:37 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021718
Page 122 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central Time
(US & Canada)Jul/24/2020
1.q Ongoing:
Date Location User Value Reason
Sep-09-2020 17:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/24/2020Initial Entry
1.r
Date Location User Value Reason
Sep-10-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Term: insomnia
Start Date: Jul/15/2020
Ongoing: YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021719
Page 123 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.r Line/MH Number:
Date Location User Value Reason
Sep-10-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
insomniaInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-10-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/15/2020Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-10-2020 14:53:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021720
Page 124 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
103.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
180.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.0Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021721
Page 125 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7.a
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-07-2020 18:21:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021722
Page 126 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-07-2020 18:21:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-07-2020 18:21:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
224438Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021723
Page 127 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 18:42:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 18:42:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020 18:42:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 18:42:03
(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-07-2020 18:42:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020 18:42:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BY2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021724
Page 128 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-07-2020 18:42:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BY2Initial Entry
5.b
Date Location User Value Reason
Aug-07-2020 18:42:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BY3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-07-2020 18:42:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BY3Initial Entry
5.c
Date Location User Value Reason
Aug-07-2020 18:42:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BY4Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-07-2020 18:42:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BY4Initial Entry
5.d
Date Location User Value Reason
Aug-07-2020 18:42:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJJRInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021725
Page 129 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Aug-07-2020 18:42:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJJRInitial Entry
5.e
Date Location User Value Reason
Aug-07-2020 18:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJJSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-07-2020 18:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJJSInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021726
Page 130 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 18:43:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 18:43:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020 18:43:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020 18:42:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BB8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 18:42:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BB8Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021727
Page 131 of 214
***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: 10951107 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-07-2020 18:22:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-07-2020 18:22:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-07-2020 18:22:51
(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-07-2020 18:22:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020 17:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-07-2020 18:22:51
(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-07-2020 18:22:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021728
Page 132 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7. Route:
Date Location User Value Reason
Aug-07-2020 18:22:51
(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-07-2020 18:22:51
(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-07-2020 18:22:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021729
Page 133 of 214
***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: 10951107 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-07-2020 18:22:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021730
Page 134 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 16:14:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021731
Page 135 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021732
Page 136 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021733
Page 137 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.d
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021734
Page 138 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.e Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021735
Page 139 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021736
Page 140 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.h Symptom:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed?
:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021737
Page 141 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SIInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021738
Page 142 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
TE
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 16:15:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021739
Page 143 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 16:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2.a
Date Location User Value Reason
Aug-27-2020 16:15:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 16:15:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-27-2020 16:15:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-27-2020 16:15:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021740
Page 144 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-27-2020 16:15:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021741
Page 145 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 16:15:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 16:15:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 11:40:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 23:13:25
(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-27-2020 16:15:48
(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-27-2020 16:15:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021742
Page 146 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-28-2020 11:40:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BG5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 11:40:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BG5Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021743
Page 147 of 214
***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: 10951107 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-27-2020 16:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 16:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 16:16:12
(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-27-2020 16:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/27/2020 15:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 16:16:12
(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-27-2020 16:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021744
Page 148 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7. Route:
Date Location User Value Reason
Aug-27-2020 16:16:12
(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-27-2020 16:16:12
(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-27-2020 16:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021745
Page 149 of 214
***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: 10951107 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-07-2020 03:01:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site confirmation
Oct-05-2020 18:10:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Participant was in
hospital and SAE has
been sent, this was
not related to COVID
but to other medical
issues.
Oct-03-2020 00:22:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened As per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced any
of the following?”
for the COVID-19
symptoms or
diagnosis on
10SEP2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Sep-28-2020 17:18:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021746
Page 150 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021747
Page 151 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021748
Page 152 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.d
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021749
Page 153 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.e Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021750
Page 154 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021751
Page 155 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.h Symptom:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021752
Page 156 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTIONInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021753
Page 157 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
SITE
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 17:19:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021754
Page 158 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 17:19:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 17:19:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 18:28:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 17:19:53
(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.
Sep-28-2020 17:19:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 18:28:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2MWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021755
Page 159 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-28-2020 18:28:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2MWInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 18:28:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2MXInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 18:28:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2MXInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 18:28:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2MYInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 18:28:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2MYInitial Entry
5.d
Date Location User Value Reason
Sep-28-2020 18:28:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCTCJInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021756
Page 160 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.d Sample ID
Date Location User Value Reason
Sep-28-2020 18:28:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPCTCJInitial Entry
5.e
Date Location User Value Reason
Sep-28-2020 18:28:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCTCKInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-28-2020 18:28:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPCTCKInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021757
Page 161 of 214
***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: 10951107 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
Sep-28-2020 17:23:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 17:23:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020 13:32:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Closed Response satisfies
query
Oct-05-2020 11:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-05-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is COMPLETED but
"Specify Status" is
Provided.
Oct-05-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered confirmed
Oct-05-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDconfirmed
Oct-02-2020 01:52:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Opened GPD CLIN: Please
confirm if subject
received 2
vaccinations and
completed Visit 3 for
the safety follow up.
If confirmed, please
update reason for
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021758
Page 162 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
EOT as "completed"
per CCG guidance.
Sep-28-2020 17:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-05-2020 11:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Oct-05-2020 10:58:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
withdrawal by participant
due to ongoing medical issuesTranscription Error
Sep-28-2020 17:23:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
due to ongoing medical issuesInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021759
Page 163 of 214
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 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
Mar-10-2021 10:36:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-09-2021 09:39:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Participant did not
sign a new consent.
Was unblinded at
participant request
so that vaccine could
be sought outside of
study.
Mar-05-2021 09:27:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened This subject has a
reconsent date of
12Feb2021. Please
confirm this
occurred, if so and
the subject is no
longer withdrawn;
please clear this
form and complete
after all scheduled
events completed.
Else clarify
Sep-28-2020 17:24:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 17:24:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 17:24:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021760
Page 164 of 214
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4. Specify Status:
Date Location User Value Reason
Sep-28-2020 17:24:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
due to ongoing medical issuesInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021761
Page 165 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021762
Page 166 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Sep-01-2020 17:23:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021763
Page 167 of 214
***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: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Sep-11-2020 17:33:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021764
Page 168 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-27-2020 16:21:48
(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
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypoglycemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/12/2020 13:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021765
Page 169 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 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
Aug-27-2020 16:21:48
(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
Aug-27-2020 16:21:48
(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
Aug-27-2020 16:21:48
(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:
Hypoglycemia, on insulin, is ty
pe II diabeticInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021766
Page 170 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-27-2020 16:21:48
(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
Aug-27-2020 16:21:48
(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
Aug-27-2020 16:21:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021767
Page 171 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Sep-06-2020 12:52:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Moved the query
under the AE of
"Dizziness".
Sep-03-2020 14:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: SAE report
states "temazepam
(RESTORIL) for
insomnia from
15Jul2020 and
ongoing". Please
clarify if insomnia is
an ongoing MHx and
if yes, please add it in
MHx section.
Sep-01-2020 17:23:07
(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-01-2020 17:23:07
(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
Nov-02-2020
23:44:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 10: Closed Response satisfies query
Nov-02-2020
16:29:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 10: Answered This has been updated and submitted.
Nov-01-2020 ACV0PFEINFP6000  Query 10: Opened Clinical - please update SAE term to
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021768
Page 172 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
17:49:31
(UTC-06:00)
Central Time (US &
Canada)match event term 'Dizziness,
secondary to Clonidine reaction' if this
is the final term
Oct-30-2020
19:59:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 9: Closed Response satisfies query
Oct-30-2020
05:13:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 8: Closed Response satisfies query
Oct-29-2020
14:31:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 9: Answered updated
Oct-29-2020
14:31:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 8: Answered updated
Oct-29-2020
14:31:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Dizziness, secondary
to Clonidine reactionupdated
Oct-23-2020
13:14:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 9: Opened Clinical - For a reaction to any
medication, please use the clinical
event that describes the reaction to
report, with AE relationship to any
medication in the Causality field.
Please update in CRF and submit SAE
followup
Oct-23-2020
05:17:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 8: Opened SAE
RECON:AER#2020353828,appreciate
the update of term to 'Reaction to
medication' but codes to “unevaluable
event” in both databases.If 'dizziness'
previously submitted is the underlying
event,please update AE CRF and
submit follow up AEM form to Safety.
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021769
Page 173 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-13-2020
09:17:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 7: Closed Response satisfies query
Oct-13-2020
09:15:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Answered New Information
Oct-13-2020
09:15:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Reaction to medicati
onNew Information
Oct-13-2020
05:52:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 7: Opened SAE RECON:AER#2020339734, the
term in Safety database was updated
to 'REACTION TO MEDICATION'
while retained as 'Dizziness'in AE
CRF. Please confirm correct term. If
safety update is required, please
submit a follow-up form.
Oct-07-2020
12:17:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 6: Closed Response satisfies query
Oct-05-2020
18:07:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 6: Answered awaiting records, at this time this is
unknown
Sep-23-2020
13:03:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 6: Opened CLINICAL If relationship of
Dizziness event to change in BP
medication is highly probable per PI,
consider updating of OTHER
relationship = 'Unknown' to change in
BP medication
Sep-23-2020
07:38:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 6: Candidate CLINICAL If relationship of
Dizziness event to change in BP
medication is highly probable per PI,
consider updating of OTHER
relationship = 'Unknown' to change in
BP medication
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021770
Page 174 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-22-2020
21:19:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 5: Closed Wait for hospital discharge summary.
Sep-11-2020
13:38:17
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 5: Opened GPDClin: Thank you for all the
responses to multiple queries! Please
try to get the discharge diagnosis
which specified the underlying
cause/condition of the dizziness
symptom.
Sep-11-2020
09:09:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies query
Sep-11-2020
08:28:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 3: Closed Response satisfies query
Sep-10-2020
14:56:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 3: Answered Yes, ongoing and this has been
updated
Sep-10-2020
14:52:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 4: Answered Due to arrhythmia, start date
unknown, will follow up with
participant
Sep-09-2020
22:02:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 2: Closed Response satisfies query
Sep-09-2020
17:24:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered This has been updated and please
know this was NOT REPORTED at
visit 1.
Sep-09-2020
12:04:22ACV0PFEINFP6000  Query 4: Opened SAE history includes pacemaker
implant on 24 Dec 2019 and explant
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(  
FDA-CBER-2021-5683-1021771
Page 175 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00)
Central Time (US &
Canada)on 24 Jul 2020; it does not specify the
condition which required a pacemaker.
Please include this information in
Medical History, as there may be
relevance to the Dizziness SAE.
Sep-09-2020
09:27:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 2: Reissued:O
penedGPDClin: The MHx module is not
frozen on my end. Please let me know
if you can update it per the previous
query re pacemaker. "Please 1) add
those in MHX; 2)also add the
corresponding medical condition as
separate MHx item for those
procedures."
Sep-08-2020
19:18:22
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered Please unfreeze medical history and
requery
Sep-06-2020
12:51:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 3: Opened GPDClin: SAE report states
"temazepam (RESTORIL) for
insomnia from 15Jul2020 and
ongoing". Please clarify if insomnia is
an ongoing MHx and if yes, please
add it in MHx section.
Sep-03-2020
14:06:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 2: Opened GPDClin: SAE report states
"pacemaker implant on 24Dec2019,
pacemaker explant on 24Jul2020".
Please 1) add those in MHX; 2)also
add the corresponding medical
condition as separate MHx item for
those procedures.
Sep-03-2020
14:02:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 1: Closed This query should be moved to MHx
section for Hypertension.
Sep-03-2020
13:57:59
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Quan Jason Gong Query 1: Opened GPDClin: Per the SAE report, the
participant started clonidine and
hydralazine for this condition started 1
day and 3 weeks prior to the 1st study
dose. Please provide assessment for
inclusion criterion 3 (stable disease in
the past 6 weeks and rationale.
Sep-01-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1021772
Page 176 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
17:23:07
(UTC-06:00)
Central Time (US &
Canada)Dizziness
4. Start Date Time:
Date Location User Value Reason
Sep-01-2020 17:23:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020 15:36:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/2/2020 UNK:UNKTranscription Error
Oct-07-2020 01:17:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-06-2020 12:21:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-05-2020 18:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered updated info
Oct-05-2020 18:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Oct-05-2020 18:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/22/2020 UNK:UNKupdated info
Oct-05-2020 13:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL -
Followup
information for
substernal Chest Pain
SAE records an event
stop date of 10 Sept
2020; please review
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021773
Page 177 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
ongoing AE status
and update as
appropriate
Sep-30-2020 04:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Thank you for
your response.
However, please
keep the query open
until updates are
made. Else clarify.
Sep-29-2020 15:49:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered awaiting records
from hospital. will
update as soon as
records received.
Sep-28-2020 17:24:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021774
Page 178 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
6. Toxicity Grade:
Date Location User Value Reason
Sep-01-2020 17:37:15
(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-30-2020 19:52:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID test
info
Oct-29-2020 14:31:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered This is being
submitted today
Oct-27-2020 21:59:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical – If Med
records not
received/subject
cannot be contacted
to state whether
hospital COVID test
was performed,
please submit this
information to a
follow-up SAE, as
pertinent information
for this trial.
Oct-26-2020 20:10:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-22-2020 14:49:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered No additional
information has been
provided regarding
this. At this time we
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021775
Page 179 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
have attempted
several times to
request records and
pt. has withdrawn
from the study.
Oct-22-2020 02:05:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020339734] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Oct-21-2020 14:04:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Candidate Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020339734] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Sep-02-2020 06:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Dizziness:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birth
defect?
NOInitial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021776
Page 180 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us 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.
Date Location User Value Reason
Sep-01-2020 17:23:07
(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
Sep-23-2020 07:37:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed change to candidate
status
Sep-11-2020 09:11:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINICAL If
relationship of
Dizziness event to
change in BP
medication is highly
probable per PI,
consider updating of
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021777
Page 181 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
OTHER relationship
= 'Unknown' to
change in BP
medication
Sep-10-2020 14:57:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI, this is highly
probable this is
related to the change
in the bp medication.
Sep-09-2020 11:45:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened due to temporal
relationship, please
evaluate possible
relationship of
Dizziness SAE to
recent new HTN
medications
Sep-01-2020 17:23:07
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-01-2020 17:23:07 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021778
Page 182 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)NO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-12-2020 08:18:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Per PSSR confirmation, the
outcome is now
recovered/resolved in Argus
DB.
Oct-11-2020 08:09:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Candidate Pending SDB update
Oct-09-2020 15:30:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered This SAE was updated on
10SEP2020. This was
refaxed today as well as
sent to ICON as requested.
Oct-06-2020 22:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened SAE RECON 1:The
outcome was reported as
NOT RECOVERED/NOT
RESOLVED on Safety
database while
RECOVERED/RESOLVED
in AE CRF. Please confirm
correct outcome.
Oct-06-2020 13:22:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Please clarify what is meant
by SDB
Oct-06-2020 06:12:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020339734
,outcome was updated to
RECOVERED/RESOLVED
in AE CRF however,
reported as NOT
RECOVERED/NOT
RESOLVED on SDB.
Please confirm correct
outcome. If safety update is
required, please submit a
follow-up form
Oct-05-2020 18:07:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021779
Page 183 of 214
***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, Locked, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-05-2020 18:07:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDupdated
Oct-05-2020 18:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Dizziness:
Response to "What was the
outcome of this adverse
event?" is 'Not
Recovered/Not Resolved'
but AE End Date/Time is
present.
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT R
ESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-01-2020 17:23:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-02-2020 06:55:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020339734Initial Entry
090177e196ae2fbe\Final\Final On: 01-Apr-2021 03:50 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021780
Page 184 of 214
***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, Locked, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951107 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Sep-11-2020 17:33:06
(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-11-2020 17:33:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Ent
…[truncated]
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