Document text
Page 1 of 164
***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: 10951141 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
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022184
Page 2 of 164
***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: 10951141 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/26/2020
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022185
Page 3 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951141]
2.Birth Date: 1969
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022186
Page 4 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022187
Page 5 of 164
***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: 10951141 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
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022188
Page 6 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022189
Page 7 of 164
***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: 10951141 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:[Type II Diabetes]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Traumatic Stress Disorder]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Deep Vein Thrombosis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Itching of Legs]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022190
Page 8 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Excessive Perspiration]
Start Date: UNK/UNK/2014
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Environmental Allergies]
Start Date: UNK/UNK/2019
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Eye Cataract Surgery]
Start Date: Aug/12/2020
Ongoing: NO
End Date:
Aug/12/2020
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Amputation of 10 Toes]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2019
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteomyelitis]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022191
Page 9 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts right eye]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Aug/12/2020
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cataracts Left eye]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Aug/12/2020
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peripheral Neuropathy secondary to Type II Diabetes]
Start Date: Jun/5/2020
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pain in feet post-op toe amputations]
Start Date: Dec/UNK/2019
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022192
Page 10 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [99.7]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [35.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022193
Page 11 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/26/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022194
Page 12 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [68046]
3.Randomization Group: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022195
Page 13 of 164
***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: 10951141 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/26/2020
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 [BPY2RJ]
5.bSample ID [BPY2RK]
5.cSample ID [BPY2RL]
5.dSample ID [BPLJLP]
5.eSample ID [BPLJLR]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022196
Page 14 of 164
***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: 10951141 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/26/2020
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 [BP3BF6]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022197
Page 15 of 164
***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: 10951141 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/26/2020 12:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022198
Page 16 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022199
Page 17 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022200
Page 18 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022201
Page 19 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022202
Page 20 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject is withdrawn from study]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022203
Page 21 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022204
Page 22 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022205
Page 23 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022206
Page 24 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022207
Page 25 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022208
Page 26 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022209
Page 27 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022210
Page 28 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022211
Page 29 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022212
Page 30 of 164
***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: 10951141 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:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022213
Page 31 of 164
***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: 10951141 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: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022214
Page 32 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022215
Page 33 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022216
Page 34 of 164
***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: 10951141 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?
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022217
Page 35 of 164
***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: 10951141 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:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022218
Page 36 of 164
***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: 10951141 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:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022219
Page 37 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022220
Page 38 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022221
Page 39 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022222
Page 40 of 164
***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: 10951141 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/16/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022223
Page 41 of 164
***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: 10951141 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/16/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022224
Page 42 of 164
***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: 10951141 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:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022225
Page 43 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022226
Page 44 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Diabetic Foot Ulcer R
Foot Sep/14/2020 UNK:
UNK YES Repeating
Pages
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022227
Page 45 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 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)[Diabetic Foot Ulcer R Foot]
4.Start Date Time: Sep/14/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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:
[Diabetes]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022228
Page 46 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022229
Page 47 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022230
Page 48 of 164
***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: 10951141 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[ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022231
Page 49 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022232
Page 50 of 164
***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: 10951141 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: //
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022233
Page 51 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022234
Page 52 of 164
***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: 10951141 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?
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022235
Page 53 of 164
***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: 10951141 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
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022236
Page 54 of 164
***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: 10951141 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?
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022237
Page 55 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022238
Page 56 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022239
Page 57 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022240
Page 58 of 164
***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: 10951141 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:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022241
Page 59 of 164
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022242
Page 60 of 164
***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: 10951141 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?
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022243
Page 61 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022244
Page 62 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022245
Page 63 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022246
Page 64 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022247
Page 65 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022248
Page 66 of 164
***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: 10951141 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 [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022249
Page 67 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - 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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022250
Page 68 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022251
Page 69 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022252
Page 70 of 164
***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: 10951141 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/16/2020
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022253
Page 71 of 164
***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: 10951141 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: [ ]
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022254
Page 72 of 164
***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: 10951141 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/16/2020
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022255
Page 73 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 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
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022256
Page 74 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 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
Name Signature
MeaningDate Type Action
Paul Pickrell Approved Nov-17-2020 19:51:59 (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.
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022257
Page 75 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-26-2020 14:54:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022258
Page 76 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022259
Page 77 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022260
Page 78 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022261
Page 79 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022262
Page 80 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022263
Page 81 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022264
Page 82 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022265
Page 83 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022266
Page 84 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-16-2020 14:00:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022267
Page 85 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022268
Page 86 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022269
Page 87 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022270
Page 88 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022271
Page 89 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022272
Page 90 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022273
Page 91 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022274
Page 92 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022275
Page 93 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022276
Page 94 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022277
Page 95 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
10Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022278
Page 96 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
11Sep-16-2020 13:37:28 (UTC-06:00) Central Time
(US & Canada)Vaccine not done as participant withdrew from the
study and verbalized wish to withdraw consent.
Not Done
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022279
Page 97 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 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
Name Signature
MeaningDate Type Action
Paul Pickrell Approved Nov-17-2020 19:51:59 (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-17-2020 15:32:00 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-14-2020 07:22:55 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-11-2020 13:52:16 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Oct-23-2020 19:06:00 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022280
Page 98 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 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.
N/A Oct-06-2020 07:47:47 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Sep-18-2020 10:24:41 (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.
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022281
Page 99 of 164
***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: 10951141 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-26-2020 14:53:42
(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-26-2020 14:53:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022282
Page 100 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 14:53:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/26/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022283
Page 101 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 14:53:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10951141Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 14:53:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1969Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 14:54:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 14:54:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 14:54:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022284
Page 102 of 164
***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: 10951141 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-26-2020 14:54:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022285
Page 103 of 164
***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: 10951141 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-26-2020 14:54:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 14:54:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 14:54:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022286
Page 104 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020 14:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Type II Diabet
es
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 14:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type II DiabetesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 14:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 14:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022287
Page 105 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-26-2020 14:56:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Post Traumatic Stres
s Disorder
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:56:06
(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-26-2020 14:56:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Post Traumatic Stress DisorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 14:56:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 14:56:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-26-2020 14:56:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Deep Vein Throm
bosis
Start Date: UNK/UNK/2015Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022288
Page 106 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:56:21
(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
Sep-11-2020 17:23:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-11-2020 14:32:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Ongoing
Sep-11-2020 09:43:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if the condition
is still
ongoing/present. If
not, please add End
Date.
Aug-26-2020 14:56:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Deep Vein ThrombosisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020 14:56:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020 14:56:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022289
Page 107 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-26-2020 14:56:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Itching of Legs
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:56:37
(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-26-2020 14:56:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Itching of LegsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020 14:56:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020 14:56:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-26-2020 14:56:49
(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
14Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022290
Page 108 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:56:49
(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
Aug-26-2020 14:56:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020 14:56:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020 14:56:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-26-2020 14:57:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Excessive Perspir
ation
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022291
Page 109 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:57:05
(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-26-2020 14:57:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Excessive PerspirationInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020 14:57:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020 14:57:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-26-2020 14:57:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Environmental All
ergies
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022292
Page 110 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:57:20
(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-26-2020 14:57:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Environmental AllergiesInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-26-2020 14:57:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-26-2020 14:57:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-26-2020 14:57:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:Right Eye Cataract
Surgery
Start Date: Aug/12/2020
Ongoing: NO
End Date:
Aug/12/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022293
Page 111 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.h Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:57:49
(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-26-2020 14:57:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Right Eye Cataract SurgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-26-2020 14:57:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-26-2020 14:57:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/12/2020Initial Entry
1.i
Date Location User Value Reason
Aug-26-2020 14:58:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Amputation of 10
Toes
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/20
19Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022294
Page 112 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.i Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:58:15
(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-26-2020 14:58:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Amputation of 10 ToesInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-26-2020 14:58:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-26-2020 14:58:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.j
Date Location User Value Reason
Aug-27-2020 16:53:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Osteomyelitis
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2019Transcription Error
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022295
Page 113 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-26-2020 14:58:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:Osteomyelitis
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022296
Page 114 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Aug-26-2020 14:58:37
(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-27-2020 17:21:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-27-2020 16:53:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Aug-27-2020 11:43:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Please
confirm if the
condition is still
ongoing. If not please
add End Date.
Aug-26-2020 14:58:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OsteomyelitisInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-26-2020 14:58:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-27-2020 16:53:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Transcription Error
Aug-26-2020 14:58:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022297
Page 115 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.k
Date Location User Value Reason
Sep-10-2020 16:23:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 11
Medical History Te
rm:cataracts right e
ye
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Aug/12/202
0Transcription Error
Sep-10-2020 16:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Te
rm:cataracts right e
ye
Start Date: UNK/UNK/202
0
Ongoing: NO
End Date:
Aug/12/202
0Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022298
Page 116 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.k Line/MH Number:
Date Location User Value Reason
Sep-10-2020 16:22:00
(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
Sep-10-2020 16:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cataracts right eyeInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-10-2020 16:23:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 16:23:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Transcription Error
Sep-10-2020 16:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
26/Aug/2020. Please
review and update as
appropriate.
Sep-10-2020 16:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-10-2020 16:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/12/2020Initial Entry
1.l
Date Location User Value Reason
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022299
Page 117 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-10-2020 16:23:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Ter
m:Cataracts Left e
ye
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
Aug/12/2020Initial Entry
1.l Line/MH Number:
Date Location User Value Reason
Sep-10-2020 16:23:53
(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
Sep-10-2020 16:23:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataracts Left eyeInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-10-2020 16:23:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-10-2020 16:23:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/12/2020Initial Entry
1.m
Date Location User Value Reason
Sep-14-2020 16:15:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:13Transcription Error
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022300
Page 118 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Medical Hi
story Term
:Peripheral Neuropathy s
econdary to Type II Dia
betes
Start Date: Jun/5/2020
Ongoing: YES
Sep-14-2020 16:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:13
Medical History
Term:Peripheral Neuro
pathy
Start Date: Jun/5/2020
Ongoing: YESTranscription Error
Sep-10-2020 16:25:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Term: Neuropathy
Start Date: Jun/5/2020
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022301
Page 119 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.m Line/MH Number:
Date Location User Value Reason
Sep-10-2020 16:25:01
(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
Sep-15-2020 23:34:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-14-2020 16:15:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral Neuropathy secondary to T
ype II DiabetesTranscription Error
Sep-14-2020 16:13:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-14-2020 16:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Sep-14-2020 16:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-14-2020 16:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Peripheral NeuropathyTranscription Error
Sep-13-2020 20:12:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened ClinQuery: Please add
the underlying cause
(e.g. diabetes,
hypertension etc.) to
the reported term; if
no underlying cause
has been identified
please add
"idiopathic".
Sep-12-2020 11:47:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 1: Opened GPDClin: Is this
peripheral neuropathy
or other types of
neuropathy, please be
more specific.
Sep-10-2020 16:25:01 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022302
Page 120 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central Time
(US & Canada)Neuropathy
1.m Start Date:
Date Location User Value Reason
Sep-10-2020 16:25:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/5/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-10-2020 16:25:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-10-2020 16:25:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Histo
ry Term:Pain in feet post-op to
e amputations
Start Date: Dec/UNK/2019
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022303
Page 121 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.n Line/MH Number:
Date Location User Value Reason
Sep-10-2020 16:25:54
(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
Sep-10-2020 16:25:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Pain in feet post-op toe amputationsInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-10-2020 16:25:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2019Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-10-2020 16:25:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Sep-10-2020 16:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:15
Medical History T
erm:Hypercholesterol
emia
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022304
Page 122 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.o Line/MH Number:
Date Location User Value Reason
Sep-10-2020 16:26:31
(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
Sep-10-2020 16:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-10-2020 16:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-10-2020 16:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022305
Page 123 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
99.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.3Initial Entry
7.a
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022306
Page 124 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022307
Page 125 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022308
Page 126 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020 14:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022309
Page 127 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 14:59:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 14:59:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
68046Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022310
Page 128 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 14:59:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 14:59:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 18:22:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 14:59:52
(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-26-2020 14:59:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 18:22:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2RJInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 18:22:46 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022311
Page 129 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central Time
(US & Canada)BPY2RJ
5.b
Date Location User Value Reason
Aug-26-2020 18:22:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2RKInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 18:22:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY2RKInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 18:22:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY2RLInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 18:22:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY2RLInitial Entry
5.d
Date Location User Value Reason
Aug-26-2020 18:23:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLJLPInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 18:23:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLJLPInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022312
Page 130 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.e
Date Location User Value Reason
Aug-26-2020 18:23:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLJLRInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 18:23:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPLJLRInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022313
Page 131 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 15:01:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 15:01:33
(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-26-2020 18:23:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 15:01:33
(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-26-2020 15:01:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 18:23:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3BF6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 18:23:30 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022314
Page 132 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central Time
(US & Canada)BP3BF6
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022315
Page 133 of 164
***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: 10951141 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-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 15:02:01
(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-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 12:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 15:02:01
(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-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022316
Page 134 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Aug-26-2020 15:02:01
(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-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-26-2020 15:02:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022317
Page 135 of 164
***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: 10951141 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-26-2020 15:02:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022318
Page 136 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020 13:33:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022319
Page 137 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 13:34:05
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1022320
Page 138 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US & Canada)
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022321
Page 139 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:Not Applicable
Test:: Choriogonadotropi
n Beta_PX113Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022322
Page 140 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Result:: Not Applicable
Not Done:: Not Applicable
Sep-16-2020 14:00:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done::Transcription Error
Sep-16-2020 13:34:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-16-2020 14:00:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Sep-16-2020 13:34:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020 13:34:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022323
Page 141 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
6.a Not Done:
Date Location User Value Reason
Sep-16-2020 14:00:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Sep-16-2020 14:00:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-16-2020 13:34:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022324
Page 142 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 13:34:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 13:34:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 05:40:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-17-2020 11:17:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Sep-17-2020 08:23:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thank you for
you response.
However, 'Sample
Collected?' is marked
as No and 'If no
sample was collected
or sample was not
collected according to
protocol, please
provide reason' is
missing. Please
review and update as
appropriate.
Sep-16-2020 13:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Participant withdrew
from study
Sep-16-2020 13:34:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022325
Page 143 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Sep-16-2020 13:34:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-17-2020 11:17:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subject is withdrawn from studyInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-1022326
Page 144 of 164
***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: 10951141 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
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Sep-18-2020
06:10:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Sep-17-2020
11:16:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredSubject returned for visit
however, decided to withdraw
from study due to health
reasons. Subject did not
receive vaccine 2.
Sep-16-2020
19:52:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4725960;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022327
Page 145 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
appropriate.
Sep-16-2020
13:37:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not D
oneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022328
Page 146 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-16-2020 13:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022329
Page 147 of 164
***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: 10951141 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-16-2020 13:38:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 13:38:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020
16:44:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Cl
osedResponse satisfies
query
Nov-17-2020
15:32:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: A
nsweredChanged data per
query
Nov-14-2020
00:53:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Re
issued:Open
edPer response please
update the Action
Taken with Study
Treatment for AE to
DRUG
WITHDRAWN.
Thank you
Nov-13-2020
17:00:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: A
nsweredPI discussed diabetes
mellitus and
numerous
comorbidities with
patient noting
worsening of diabetic
neuropathy and need
to Rx a foot ulcer.
Patient withdrew
consent to focus on
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022330
Page 148 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
health issues.
Nov-13-2020
09:52:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Re
issued:Open
edDM1: Please verify
query response since
the Vaccination at
visit 2 is entered as
"Not Done". Please
review and update as
appropriate.
Nov-12-2020
17:23:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: A
nsweredParticipant did
withdraw from the
study due to AE.
Drug withdrawn is
N/A as she already
received her 2
vaccines.
Nov-11-2020
17:36:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 4: O
penedDMW5359691;Status
is reported as Adverse
Event, but there is no
Adverse Event with
'Latest Action Taken
with Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as appropriate.
Nov-11-2020
13:53:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Cl
osedClose Auto Query
Nov-11-2020
13:52:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: O
penedResponse to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Nov-11-2020
13:52:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
ADVERSE
EVENTupdated
Oct-07-2020
19:08:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Cl
osedResponse satisfies
query
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022331
Page 149 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-06-2020
07:48:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: A
nsweredThis has been
updated, this is NA as
there is no drug to
withdraw
Oct-05-2020
20:22:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: O
penedClinQuery: Diabetic
Foot Ulcer R Foot is
listed to have drug
withdrawn on 14 Sep,
however, EOT is
completed on 16 Sep.
Please review and
update as appropriate
Sep-18-2020
05:31:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies
query
Sep-16-2020
13:39:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: A
nsweredPlease advise on
initiation of this form
Sep-16-2020
13:38:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: O
penedStatus is selected as
''WITHDRAWAL BY
SUBJECT'' and
WITHDRAWAL OF
CONSENT form is
not initiated. Please
review and update as
appropriate.
Sep-16-2020
13:38:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
WITHDRA
WAL BY S
UBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-11-2020 13:53:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: subject withdrawn
due to AE
Sep-16-2020 13:38:48
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
Consent withdrawn as wellInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1022332
Page 150 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US & Canada)
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022333
Page 151 of 164
***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: 10951141 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-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 13:54:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-11-2020 13:54:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-11-2020 13:54:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ADVERSE EVENTSubject withdrawn
from study due to AE
Sep-18-2020 05:35:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Sep-16-2020 13:42:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Please advise on how
to initiate this form
Sep-16-2020 13:40:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Status is selected as
''WITHDRAWAL BY
SUBJECT'' and
WITHDRAWAL OF
CONSENT form is not
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022334
Page 152 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
initiated. Please
review and update as
appropriate.
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-11-2020 13:54:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Sep-16-2020 13:40:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant withdrew from study and
is withdrawing consentInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022335
Page 153 of 164
***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: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022336
Page 154 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Sep-16-2020 13:47:21
(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-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020 18:32:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-22-2020 14:54:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Participant requested
to withdraw to focus
on other ongoing
health issues, this is
tied into the ongoing
diabetic foot ulcer but
at her request.
Oct-18-2020 19:52:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clin:Diabetic Foot
Ulcer R Foot: Per
adverse event log AE
caused the subject to
be discontinued from
the study. Disposition
Treatment CRF &
Disposition
Follow-up CRF
statuses are not
'Adverse
Event'.Please review
section 8.55.2 of the
CCR and update.
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Diabetic Foot Ulcer R FootInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022337
Page 155 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4. Start Date Time:
Date Location User Value Reason
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020 05:38:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-16-2020 13:48:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Participant reported
this today, wound
was debrided but
participant has
withdrawn consent.
Sep-16-2020 13:47:21
(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-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022338
Page 156 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-16-2020 13:47:21
(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
Sep-16-2020 13:47:21
(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-16-2020 13:47:21
(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:
DiabetesInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 15:32:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNTranscription Error
Oct-07-2020 19:08:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-06-2020 07:47:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated
Oct-06-2020 07:47:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEupdated
Oct-05-2020 20:23:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Diabetic
Foot Ulcer R Foot is
listed to have drug
withdrawn, however,
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022339
Page 157 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
the EOT page states
primary reason for
discontinuation was
withdrawal by subject.
Please review and
update as appropriate
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-16-2020 13:47:21
(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-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-16-2020 13:47:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 23:43:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-11-2020 13:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Both EOT and FUP
have been updated to
reflect AE as reason
for discontinuing in
study.
Nov-11-2020 09:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM RQ:The EOT and
FUP form have been
unfrozen. Please
update the EOT and
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1022340
Page 158 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
FUP forms.
Nov-10-2020 17:31:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Can you please query
on area you are
requesting change?
Nov-07-2020 07:40:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened The form is
unfroze.Per Adverse
Event form, AE was
the reason for
discontinued from the
study. However
DISPOSITION -
TREATMENT and
DISPOSITION -
FOLLOW-UP do not
have the Status
updated as Adverse
Event. Please review
and update as
appropriate.
Nov-06-2020 15:06:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please unfreeze and
requery
Nov-05-2020 20:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine Puig Query 2: Opened DM: Per Adverse
Event form, AE was
the reason for
discontinued from the
study. However
DISPOSITION -
TREATMENT and
DISPOSITION -
FOLLOW-UP do not
have the Status
updated as Adverse
Event. Please review
and update as
appropriate.
Oct-02-2020 09:52:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-30-2020 14:19:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This was a withdraw
by participant so that
she could focus on
ongoing health issues,
this includes the
diabetic foot ulcer.
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022341
Page 159 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-30-2020 03:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM 1: Response to
Did the adverse event
cause the subject to be
discontinued from the
study? Is YES.
However, 'Status is
recorded as
"WITHDRAWAL BY
SUBJECT" on EOT
and DISPOSTION
FOLLOW UP forms.
Please review and
update.
Sep-29-2020 11:16:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered both disposition
treatment and
disposition follow up
have been updated
Sep-27-2020 02:31:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: As per Adverse
Event form, AE was
the reason for
discontinued from the
study. However
DISPOSITION -
TREATMENT and
DISPOSITION -
FOLLOW-UP do not
have the Status
updated as Adverse
Event. Please review
and update as
appropriate.
Sep-25-2020 07:55:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered I am seeing these
completed. Please let
me know if this needs
follow up
Sep-23-2020 04:18:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022342
Page 160 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
appropriate.
Sep-16-2020 13:47:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-16-2020 13:47:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1022343
Page 161 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Sep-16-2020 13:45:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022344
Page 162 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020 13:54:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDSubject withdrawn
from study due to AE
Nov-11-2020 13:52:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDupdated
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-16-2020 13:38:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-26-2020 14:59:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-26-2020 14:54:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 13:54:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Subject withdrawn
from study due to AE
Nov-11-2020 13:52:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020updated
Sep-16-2020 13:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
Sep-16-2020 13:38:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/16/2020Initial Entry
Aug-26-2020 14:59:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022345
Page 163 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-26-2020 14:54:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022346
Page 164 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-16-2020 13:39:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fb9\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022347