Document text
Page 1 of 460
***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: 10951009 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 version30 JUN 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020530
Page 2 of 460
***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: 10951009 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
Jul/31/2020
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020531
Page 3 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951009]
2.Birth Date: /1981
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:
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020532
Page 4 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/31/2020
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020533
Page 5 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and in this
protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020534
Page 6 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study
intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020535
Page 7 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020536
Page 8 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of
the study, site staff otherwise supervised by the investigator, and their
respective family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020537
Page 9 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJul/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020538
Page 10 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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:[Moderate Anxiety]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[subdural hematoma]
Start Date: Apr/3/2006
Ongoing: NO
End Date:
Apr/5/2006
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: May/15/2018
Ongoing: NO
End Date:
May/15/2018
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2015
Ongoing: YES
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020539
Page 11 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sinus surgery]
Start Date: Apr/UNK/2020
Ongoing: NO
End Date:
Apr/UNK/2020
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[deviated septum]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
Apr/UNK/2020
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heavy menses]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
May/15/2018
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020540
Page 12 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Jul/31/2020
2.Weight: [81.6]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020541
Page 13 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020542
Page 14 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Jul/31/2020
2.Randomization Number: [40705]
3.Randomization Group: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020543
Page 15 of 460
***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: 10951009 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:
Jul/31/2020
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 [BP3BLG]
5.bSample ID [BP3BLH]
5.cSample ID [BP3BLJ]
5.dSample ID [BPLJ9V]
5.eSample ID [BPLJ9W]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020544
Page 16 of 460
***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: 10951009 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:
Jul/31/2020
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 [BP3B72]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020545
Page 17 of 460
***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: 10951009 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: Jul/31/2020 10:11
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
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020546
Page 18 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020547
Page 19 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020548
Page 20 of 460
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020549
Page 21 of 460
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020550
Page 22 of 460
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020551
Page 23 of 460
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020552
Page 24 of 460
***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: 10951009 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/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3BC2]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020553
Page 25 of 460
***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: 10951009 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/21/2020 11:42
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
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020554
Page 26 of 460
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020555
Page 27 of 460
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020556
Page 28 of 460
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020557
Page 29 of 460
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BPY2CC]
5.bSample ID [BPY2CD]
5.cSample ID [BPY2CF]
5.dSample ID [BPCT75]
5.eSample ID [BPCT76]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020558
Page 30 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020559
Page 31 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom Started: Nov/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020560
Page 32 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020561
Page 33 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/5/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020562
Page 34 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/5/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: INDETERMINATE
8.Comments/Findings/Details: [Per Pt, results negative DAO 12NOV2020]
9.Trade Name Other, Specify: [NALT unknown]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020563
Page 35 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/9/2020
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 [RW80000]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020564
Page 36 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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:[home self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020565
Page 37 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020566
Page 38 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020567
Page 39 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020568
Page 40 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020569
Page 41 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[viral upper respiratory Infection]
Date of Diagnosis:
Nov/10/2020
3.Toxicity Grade: 2
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020570
Page 42 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020571
Page 43 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020572
Page 44 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020573
Page 45 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020574
Page 46 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020575
Page 47 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020576
Page 48 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020577
Page 49 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done Sponsor-Define
d IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020578
Page 50 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020579
Page 51 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020580
Page 52 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020581
Page 53 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020582
Page 54 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020583
Page 55 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020584
Page 56 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020585
Page 57 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020586
Page 58 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020587
Page 59 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020588
Page 60 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020589
Page 61 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020590
Page 62 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020591
Page 63 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020592
Page 64 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020593
Page 65 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020594
Page 66 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020595
Page 67 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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:
Dec/8/2020
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 [BP1T3Z]
5.bSample ID [BP1T3Y]
5.cSample ID [BP1T3X]
5.dSample ID [BPLJZR]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020596
Page 68 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020597
Page 69 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020598
Page 70 of 460
***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: 10951009 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/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020599
Page 71 of 460
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020600
Page 72 of 460
***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: 10951009 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:
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020601
Page 73 of 460
***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: 10951009 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 [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020602
Page 74 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 torsion of right
ovary Dec/23/2020 UNK
:UNK NO
End Date Time:
Jan/18/2021 UNK:UNK
Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020603
Page 75 of 460
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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)[torsion of right ovary]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/18/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020604
Page 76 of 460
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[ovarian cyst]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021113364]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020605
Page 77 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020606
Page 78 of 460
***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: 10951009 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[ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020607
Page 79 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020608
Page 80 of 460
***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: 10951009 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: //
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020609
Page 81 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020610
Page 82 of 460
***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: 10951009 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?
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020611
Page 83 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020612
Page 84 of 460
***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: 10951009 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?
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020613
Page 85 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020614
Page 86 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020615
Page 87 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020616
Page 88 of 460
***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: 10951009 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:
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020617
Page 89 of 460
***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: 10951009 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:
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020618
Page 90 of 460
***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: 10951009 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?
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020619
Page 91 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020620
Page 92 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020621
Page 93 of 460
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020622
Page 94 of 460
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020623
Page 95 of 460
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020624
Page 96 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020625
Page 97 of 460
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification
of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020626
Page 98 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020627
Page 99 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/3/2021
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020628
Page 100 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020629
Page 101 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020630
Page 102 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020631
Page 103 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR3WKL]
5.bSample ID [BR3WKM]
5.cSample ID [BR3WKN]
5.dSample ID [BPCTK9]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020632
Page 104 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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:
Feb/3/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0VFM]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020633
Page 105 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 14:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020634
Page 106 of 460
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020635
Page 107 of 460
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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: Mar/2/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020636
Page 108 of 460
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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:
Mar/2/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0VGB]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020637
Page 109 of 460
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/2/2021 14:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020638
Page 110 of 460
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020639
Page 111 of 460
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020640
Page 112 of 460
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020641
Page 113 of 460
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020642
Page 114 of 460
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020643
Page 115 of 460
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020644
Page 116 of 460
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
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Subject No: 10951009 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
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Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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6.aAug-24-2020 18:43:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Subject No: 10951009 Subject Initials: ---
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
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ItemDate User Comment
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Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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ItemDate User Comment
5.aNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
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Time (US & Canada)Not Done
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Site No: 1095 Site Name: (1095) Tekton Research
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
5.dNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
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Time (US & Canada)Not Done
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ItemDate User Comment
5.dNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Site No: 1095 Site Name: (1095) Tekton Research
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5.eNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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ItemDate User Comment
5.eNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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5.eNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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5.eNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Time (US & Canada)Not Done
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ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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ItemDate User Comment
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Time (US & Canada)Not Done
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ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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ItemDate User Comment
5.gNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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ItemDate User Comment
5.gNov-10-2020 09:38:41 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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2Nov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Time (US & Canada)Not Done
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
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Time (US & Canada)Not Done
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***Confidential***
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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5.eNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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5.eNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Back to Form
ItemDate User Comment
5.gNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.gNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.hNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.hNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.hNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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FDA-CBER-2021-5683-1020740
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
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Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
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FDA-CBER-2021-5683-1020743
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.iNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020745
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***Confidential***
Header Text: c4591001
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020746
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***Confidential***
Header Text: c4591001
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on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020747
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***Confidential***
Header Text: c4591001
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on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5.jNov-10-2020 09:38:58 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020748
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Header Text: c4591001
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020749
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020750
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020751
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020752
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020753
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-10-2020 09:39:13 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020754
Page 226 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-10-2020 09:39:32 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020755
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-10-2020 09:39:32 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020756
Page 228 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2.aNov-10-2020 09:39:32 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-1020757
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-10-2020 09:40:01 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-1020758
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-10-2020 09:40:01 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-1020759
Page 231 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-10-2020 09:40:01 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-1020760
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-10-2020 09:40:01 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020761
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020762
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-1020763
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020764
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020765
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020766
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020767
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Nov-10-2020 09:40:14 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020768
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormNov-10-2020 09:40:26 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020769
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Nov-10-2020 09:40:26 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
(6)
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FDA-CBER-2021-5683-1020770
Page 242 of 460
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Nov-10-2020 09:40:26 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020771
Page 243 of 460
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Nov-10-2020 09:40:26 (UTC-06:00) Central
Time (US & Canada)Not Done
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b)
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FDA-CBER-2021-5683-1020772
Page 244 of 460
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Nov-10-2020 09:40:26 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), (b)
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-08-2021 08:22:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-03-2021 16:20:57 (UTC-06:00) Central
Time (US & Canada)
FormFeb-03-2021 16:19:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b)
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Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-08-2021 08:22:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-04-2021 13:16:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-03-2021 16:20:57 (UTC-06:00) Central
Time (US & Canada)
1Feb-03-2021 16:19:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
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FDA-CBER-2021-5683-1020775
Page 247 of 460
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Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-08-2021 08:21:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-03-2021 16:21:24 (UTC-06:00) Central
Time (US & Canada)
FormFeb-03-2021 16:20:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\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-2021-5683-1020776
Page 248 of 460
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-08-2021 08:21:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-04-2021 13:16:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-03-2021 16:21:24 (UTC-06:00) Central
Time (US & Canada)
1Feb-03-2021 16:20:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\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-2021-5683-1020777
Page 249 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-03-2021 16:22:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020778
Page 250 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020779
Page 251 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020780
Page 252 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020781
Page 253 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020782
Page 254 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020783
Page 255 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Feb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020784
Page 256 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aFeb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020785
Page 257 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aFeb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020786
Page 258 of 460
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aFeb-03-2021 16:23:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020787
Page 259 of 460
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-03-2021 16:19:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Jan-22-2021 17:10:48 (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 Dec-09-2020 14:21:38 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-14-2020 07:15:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020788
Page 260 of 460
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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 Nov-11-2020 08:08:26 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Nov-10-2020 21:14:01 (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-10-2020 09:30:54 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Oct-12-2020 19:03:39 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020789
Page 261 of 460
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 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 Sep-22-2020 09:13:20 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell Approved Sep-18-2020 09:28:59 (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.
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020790
Page 262 of 460
***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: 10951009 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
Jul-31-2020 08:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jul-31-2020 08:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020791
Page 263 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Jul-31-2020 08:54:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Jul/31/2020Initial Entry
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020792
Page 264 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Jul-31-2020 08:53:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10951009Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Jul-31-2020 08:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1981Enrollment Entry
3. Sex:
Date Location User Value Reason
Jul-31-2020 08:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jul-31-2020 12:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Jul-31-2020 12:18:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
196ae2fb6\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-2021-5683-1020793
Page 265 of 460
***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: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-31-2020 08:54:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/31/2020Initial Entry
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020794
Page 266 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Male or female partici
pants between the ages
of 18 and 55 years, inc
lusive, 65 and 85 years
, inclusive, or 18 and 8
5 years, inclusive, at ra
ndomization (depende
nt upon study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24 ACV0PFEINFP6000 Data Entry: Initial Entry
196ae2fb6\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-2021-5683-1020795
Page 267 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Male or female participants bet
ween the ages of 18 and 55 yea
rs, inclusive, 65 and 85 years, i
nclusive, or 18 and 85 years, in
clusive, at randomization (dep
endent upon study stage)
1.a Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion D
escrip
tion:Participants who are w
illing and able to com
ply with all scheduled
visits, vaccination pla
n, laboratory tests, life
style considerations, a
nd other study proced
ures
Criter
ion m
et?:YESInitial Entry
196ae2fb6\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-2021-5683-1020796
Page 268 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, la
boratory tests, lifestyle conside
rations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
196ae2fb6\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-2021-5683-1020797
Page 269 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:3
Criter
ion D
escrip
tion:Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of the
investigator to be eligi
ble for inclusion in the
study
Criter
ion m
et?:YES
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN03A00Initial Entry
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020798
Page 270 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Inclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are d
etermined by medical history,
physical examination, and clini
cal judgment of the investigato
r to be eligible for inclusion in
the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:4Initial Entry
196ae2fb6\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-2021-5683-1020799
Page 271 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criter
ion De
scripti
on:Capable of giving pers
onal signed informed
consent, which includ
es compliance with th
e requirements and res
trictions listed in the I
CD and in this protoco
l
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020800
Page 272 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Inclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the re
quirements and restrictions list
ed in the ICD and in this proto
colInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:1Initial Entry
196ae2fb6\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-2021-5683-1020801
Page 273 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Crite
rion
Descr
iption
:Other medical or psyc
hiatric condition incl. r
ecent (within past year
) or active suicidal ide
ation/behavior/lab abn
ormality that may incr
ease the risk of study p
articipation
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideati
on/behavior/lab abnormality th
at may increase the risk of stud
y participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24 ACV0PFEINFP6000 Data Entry: Initial Entry
196ae2fb6\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-2021-5683-1020802
Page 274 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)NO
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Desc
ription:Known infection wit
h human immunodef
iciency virus (HIV),
hepatitis C virus (HC
V), or hepatitis B vir
us (HBV)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX02A00Initial Entry
196ae2fb6\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-2021-5683-1020803
Page 275 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.b Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human i
mmunodeficiency virus (HIV),
hepatitis C virus (HCV), or he
patitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:3Initial Entry
196ae2fb6\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-2021-5683-1020804
Page 276 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criter
ion De
scripti
on:History of severe adve
rse reaction associated
with a vaccine and/or
severe allergic reactio
n (eg, anaphylaxis) to
any component of the
study intervention(s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020805
Page 277 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.c Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse react
ion associated with a vaccine a
nd/or severe allergic reaction (
eg, anaphylaxis) to any compo
nent of the study intervention(s
)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:4Initial Entry
196ae2fb6\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-2021-5683-1020806
Page 278 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criterion
Description
:Receipt of medic
ations intended t
o prevent COVI
D-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intende
d to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
196ae2fb6\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-2021-5683-1020807
Page 279 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:8
Criter
ion De
scripti
on:Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
amination
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00Initial Entry
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1020808
Page 280 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.e Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individu
als with known or suspected i
mmunodeficiency, as determin
ed by history and/or laboratory
/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:10Initial Entry
196ae2fb6\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-2021-5683-1020809
Page 281 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criter
ion De
scripti
on:Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the o
pinion of the investiga
tor, contraindicate intr
amuscular injection
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
196ae2fb6\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1020810
Page 282 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.f Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition
associated with prolonged blee
ding that would, in the opinion
of the investigator, contraindic
ate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:11
Criterion De
scription:Women who ar
e pregnant or b
reastfeedingInitial Entry
196ae2fb6\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)
FDA-CBER-2021-5683-1020811
Page 283 of 460
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951009 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Jul-31-2020 12:19:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reaso
…[truncated]