Document text
Page 1 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986054
Page 2 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/22/2020
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986055
Page 3 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401306]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986056
Page 4 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986057
Page 5 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986058
Page 6 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986059
Page 7 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[acid reflux]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/2007
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[fundal plication]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[left tarsal bone fracture, foot]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[left avulsion fracture, foot]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis, both knees]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986060
Page 8 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[hypothyroidism]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[eye allergies]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[penicillin allergy]
Start Date: UNK/UNK/1971
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic Spastic Paraparesis]
Start Date: Sep/UNK/2020
Ongoing: YES
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986061
Page 9 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986062
Page 10 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
2.Weight: [180.4]
3.Unit: LB
4.Height: [73.78]
5.Unit: in
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986063
Page 11 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/22/2020
2.Randomization Number: [110686]
3.Randomization Group: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986064
Page 12 of 225
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BP8DDL]
5.bSample ID [BLGBL9]
5.cSample ID [BLGBLB]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986065
Page 13 of 225
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BP8DDK]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986066
Page 14 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Oct/22/2020 16:23
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
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986067
Page 15 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986068
Page 16 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986069
Page 17 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986070
Page 18 of 225
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [BP8DHH]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986071
Page 19 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?Not Done Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986072
Page 20 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986073
Page 21 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986074
Page 22 of 225
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986075
Page 23 of 225
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986076
Page 24 of 225
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986077
Page 25 of 225
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986078
Page 26 of 225
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986079
Page 27 of 225
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986080
Page 28 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986081
Page 29 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986082
Page 30 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986083
Page 31 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986084
Page 32 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986085
Page 33 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986086
Page 34 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Applicable Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986087
Page 35 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986088
Page 36 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986089
Page 37 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986090
Page 38 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Worsening of Chronic Spastic Pa
raparesis Nov/7/2020 14:00 YES Repeating
Pages
2.ADVERSE EV
ENT 2 short term memory loss Nov/7/2020 19:00 NO
End Date Time:
Nov/10/2020 08:00
Repeating
Pages
3.ADVERSE EV
ENT 3 Change in Visual Perception Nov/7/2020 14:00 NO
End Date Time:
Nov/9/2020 10:30
Repeating
Pages
4.ADVERSE EV
ENT 4 Bilateral Eye Pain Nov/7/2020 UNK:
UNK NO
End Date Time:
Jan/1/2021 UNK:UNK
Repeating
Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986091
Page 39 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Worsening of Chronic Spastic Paraparesis]
4.Start Date Time: Nov/7/2020 14:00
5.Is the adverse event still ongoing? YES
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).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown at this time]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986092
Page 40 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986093
Page 41 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[short term memory loss]
4.Start Date Time: Nov/7/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/10/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown at this time]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? YES
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986094
Page 42 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[2020449153]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986095
Page 43 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Change in Visual Perception]
4.Start Date Time: Nov/7/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 10:30
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
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:
[Spontaneous resolution, cause is unknown]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? NO
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986096
Page 44 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020449153]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986097
Page 45 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Bilateral Eye Pain]
4.Start Date Time: Nov/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/1/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[visual correction improved which was the cause (corrected vision with glasses)]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986098
Page 46 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986099
Page 47 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
1. Repeating Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986100
Page 48 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986101
Page 49 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ident
ifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986102
Page 50 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: //
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986103
Page 51 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
1. Repeating
Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986104
Page 52 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986105
Page 53 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986106
Page 54 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986107
Page 55 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986108
Page 56 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986109
Page 57 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986110
Page 58 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986111
Page 59 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986112
Page 60 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986113
Page 61 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986114
Page 62 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986115
Page 63 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986116
Page 64 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986117
Page 65 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986118
Page 66 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986119
Page 67 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986120
Page 68 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986121
Page 69 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986122
Page 70 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986123
Page 71 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986124
Page 72 of 225
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986125
Page 73 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986126
Page 74 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986127
Page 75 of 225
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Feb/23/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986128
Page 76 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986129
Page 77 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986130
Page 78 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986131
Page 79 of 225
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/23/2021
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986132
Page 80 of 225
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986133
Page 81 of 225
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986134
Page 82 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-23-2020 09:10:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986135
Page 83 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-13-2020 16:14:36 (UTC-05:00) Eastern Time
(US & Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986136
Page 84 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986137
Page 85 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986138
Page 86 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986139
Page 87 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986140
Page 88 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986141
Page 89 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986142
Page 90 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986143
Page 91 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986144
Page 92 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986145
Page 93 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986146
Page 94 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
11Nov-13-2020 16:14:36 (UTC-05:00) Eastern Time (US
& Canada)Vaccination withheld due to serious adverse event that
occurred previously. Subject came for visit and
evaluation.
Not Done
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986147
Page 95 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-13-2021 11:12:29 (UTC-05:00) Eastern Time (US
& Canada)No Corresponding Cov ILL was conducted. This CRF
is being completed only to record blood sample
barcodes per previous query request. Subject was on
site for a unscheduled safety visit following unplanned
contact. Samples were collected as COVID_A1 visit.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986148
Page 96 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Feb-03-2021 14:58:58 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986149
Page 97 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-11-2021 16:07:00 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
Not Applicable
FormFeb-04-2021 10:03:25 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
FormJan-13-2021 11:20:50 (UTC-05:00) Eastern Time (US
& Canada)No Corresponding Cov ILL was conducted. This CRF
is being completed only to record blood sample
barcodes per previous query request. Subject was on
site for a unscheduled safety visit following unplanned
contact. Samples were collected as COVID_A1 visit.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986150
Page 98 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-11-2021 16:07:00 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986151
Page 99 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Feb-11-2021 16:07:00 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986152
Page 100 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Feb-11-2021 16:07:00 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986153
Page 101 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Feb-11-2021 16:07:00 (UTC-05:00) Eastern Time (US
& Canada)NOT APPLICABLE
Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986154
Page 102 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-13-2020 16:15:43 (UTC-05:00) Eastern Time
(US & Canada)Data for this Visit entered under Vaccine 2 visit and
this Unplanned visit should be disregarded. Guidance
was given by monitor to enter data under vaccine 2
despite not being a visit in which the vaccine was
provided.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986155
Page 103 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-17-2020 13:54:03 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986156
Page 104 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-17-2020 13:54:03 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986157
Page 105 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-17-2020 13:54:17 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986158
Page 106 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-17-2020 13:54:17 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986159
Page 107 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Nov-17-2020 13:54:17 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986160
Page 108 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Nov-17-2020 13:54:17 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986161
Page 109 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-17-2020 13:54:35 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986162
Page 110 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-17-2020 13:54:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986163
Page 111 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aNov-17-2020 13:54:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986164
Page 112 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aNov-17-2020 13:54:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986165
Page 113 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2.aNov-17-2020 13:54:35 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986166
Page 114 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Nov/13/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-17-2020 13:54:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986167
Page 115 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986168
Page 116 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Nov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986169
Page 117 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Nov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986170
Page 118 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4.aNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986171
Page 119 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4.bNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986172
Page 120 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.aNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986173
Page 121 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.bNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986174
Page 122 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.cNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986175
Page 123 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.dNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986176
Page 124 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.eNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986177
Page 125 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 fNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986178
Page 126 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5.gNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986179
Page 127 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION - SYSTEMIC
EVENT - Comments
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5 hNov-17-2020 13:54:50 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986180
Page 128 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 14:58:58 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas Approved Jan-28-2021 20:50:22 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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 Jan-27-2021 10:08:11 (UTC-05:00) Eastern Time (US
& Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas Approved Jan-25-2021 11:51:23 (UTC-05:00) Eastern Time (US
& Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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 Jan-13-2021 11:09:52 (UTC-05:00) Eastern Time (US
& Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986181
Page 129 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Stephen Thomas Approved Jan-10-2021 21:06:51 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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-04-2020 08:19:39 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas Approved Dec-02-2020 11:29:16 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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-23-2020 15:31:55 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Thomas Approved Nov-20-2020 13:04:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-17-2020 19:32:18 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986182
Page 130 of 225
***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: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
Stephen Thomas Approved Nov-17-2020 18:27:57 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenThomas, 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.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986183
Page 131 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-23-2020 09:10:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-23-2020 09:10:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986184
Page 132 of 225
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-23-2020 09:10:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/22/2020Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986185
Page 133 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-14-2020 11:00:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed event added in AE CRF
Nov-13-2020 07:21:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020449153
change in visual
perception, short term
memory loss(onset
date:07Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-23-2020 09:10:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11401306Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-23-2020 09:08:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-23-2020 09:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-23-2020 09:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986186
Page 134 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-23-2020 09:10:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986187
Page 135 of 225
***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, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 09:10:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986188
Page 136 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-23-2020 09:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 09:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 09:11:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986189
Page 137 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Oct-23-2020 09:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:acid reflux
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/20
07Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
acid refluxInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-23-2020 09:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-23-2020 09:12:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.b
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986190
Page 138 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-23-2020 09:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:fundal plication
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/20
07Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
fundal plicationInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-23-2020 09:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-23-2020 09:12:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.c
Date Location User Value Reason
Oct-23-2020 09:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:left tarsal bone fractu
re, footTranscription Error
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986191
Page 139 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
Oct-23-2020 09:13:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:left tarsal bone frac
ture
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/200
2Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:13:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:15:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
left tarsal bone fracture, footTranscription Error
Oct-23-2020 09:13:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
left tarsal bone fractureInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-23-2020 09:13:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-23-2020 09:13:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986192
Page 140 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d
Date Location User Value Reason
Oct-23-2020 09:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:left avulsion fracture
, foot
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
left avulsion fracture, footInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-23-2020 09:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-23-2020 09:15:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.e
Date Location User Value Reason
Oct-23-2020 09:16:09
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
Line/MH Number 5Transcription Error
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986193
Page 141 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) :
Medical History T
erm:osteoarthritis, both
knees
Start Date: UNK/UNK/2016
Ongoing: YES
Oct-23-2020 09:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:osteoarthritis
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritis, both kneesTranscription Error
Oct-23-2020 09:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritisInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-23-2020 09:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-23-2020 09:15:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986194
Page 142 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-23-2020 09:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Term
:hypothyroidism
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-23-2020 09:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-23-2020 09:16:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-23-2020 09:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Term
:eye allergies
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986195
Page 143 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
eye allergiesInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-23-2020 09:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-23-2020 09:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-23-2020 09:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Term
:penicillin allerg
y
Start Date: UNK/UNK/197
1
Ongoing: YESInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986196
Page 144 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.h Line/MH Number:
Date Location User Value Reason
Oct-23-2020 09:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 09:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
penicillin allergyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-23-2020 09:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1971Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-23-2020 09:17:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Nov-23-2020 15:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Chronic Spastic Para
paresis
Start Date: Sep/UNK/2020
Ongoing: YESInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986197
Page 145 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Nov-23-2020 15:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020 15:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic Spastic ParaparesisInitial Entry
1.i Start Date:
Date Location User Value Reason
Nov-23-2020 15:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-23-2020 15:31:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986198
Page 146 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-23-2020 09:17:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV PO
SITIVEInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986199
Page 147 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
180.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
73.78Initial Entry
5. Unit:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3Initial Entry
7.a
Date Location User Value Reason
Oct-23-2020 09:17:58 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986200
Page 148 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)Record Identifier:: 1
Temperature: 98.5
Temperature Unit: F
Temperature Location
::ORAL CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-23-2020 09:17:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986201
Page 149 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-23-2020 09:31:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-27-2020 11:51:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-26-2020 13:46:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-26-2020 13:46:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
110686Transcription Error
Oct-24-2020 08:15:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Impala,
Randomization Number
is 110686, but in the
randomization CRF
Randomization Number
is 110668. Please
review and update as
appropriate.
Oct-23-2020 09:31:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
110668Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986202
Page 150 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 09:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 09:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 09:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 09:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-23-2020 09:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 09:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DDLInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 09:46:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DDLInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986203
Page 151 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b
Date Location User Value Reason
Oct-23-2020 09:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBL9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 09:46:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBL9Initial Entry
5.c
Date Location User Value Reason
Oct-23-2020 09:46:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBLBInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 09:46:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBLBInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986204
Page 152 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 09:18:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 09:18:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 09:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 09:18:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-23-2020 09:18:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 09:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DDKInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 09:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DDKInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986205
Page 153 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/22/2020 16:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-23-2020 09:19:22 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986206
Page 154 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-23-2020 09:19:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986207
Page 155 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-23-2020 09:19:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986208
Page 156 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020
15:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Closed Auto closed by
Validation Check:
VC_SV001_02
Nov-16-2020
12:42:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answer
edwe are unable to
delete UNPL crf.
This data belongs to
V2. See form level
comment for UNPL
visit
Nov-14-2020
03:29:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Opened DMW5380191;The
Date of Visit at
UNPL is same as the
Date of Visit at
V2_VAX2_L. Please
review for
duplication and
update as
appropriate.
Nov-13-2020
16:11:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0986209
Page 157 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2.a
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Location
::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-13-2020 16:11:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986210
Page 158 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:12:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:12:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 16:12:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:12:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-13-2020 16:12:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 16:13:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DHHTranscription Error
Nov-13-2020 16:12:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DHKInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986211
Page 159 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-13-2020 16:13:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DHHTranscription Error
Nov-13-2020 16:12:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DHKInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986212
Page 160 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-03-2020
05:28:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: C
losedNo Data Issue
Dec-02-2020
16:35:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: O
penedDMW6297485;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Nov-13-2020
16:14:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entr
y:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0986213
Page 161 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-13-2020 16:14:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986214
Page 162 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 04:59:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-11-2021 16:07:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered updated per query
request
Feb-04-2021 23:56:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1 : Thanks for
response. Please review
and consider to add
Form level comment as
Not Applicable on
SAMP TRK form.
Else, clarify.
Feb-04-2021 10:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per query
Jan-29-2021 15:09:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-28-2021 00:02:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Erroneous visit is
marked. However, data
is present on SAMP
TRK form. Kindly
consider to erase the
data and add form level
comment by selecting
Not Done or Not
Applicable option on
the SAMP TRK form
accordingly or else
clarify.
Jan-27-2021 10:08:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
either untick the
erroneous visit button
if visit occurred, or
mark any forms
containing data within
this visit as Not
Done/Not Applicable at
the form level.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986215
Page 163 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-15-2021 16:04:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Site to follow up with
CRA on how to enter
these data
Jan-13-2021 15:32:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Will reach out to CRA
re: entering barcodes
for an unscheduled
safety visit.
Jan-13-2021 14:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Per query
response on subject
status this was an
unplanned visit where
serum was collected.
Convalescent visits
should not be entered if
no illness visits have
occurred. Please follow
up with CRA about
where/if barcodes
should be entered.
Jan-13-2021 11:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-27-2021 11:54:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-27-2021 10:08:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-27-2021 10:08:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
Jan-25-2021 11:30:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened If the CONVA Visit did
not occur, please mark
as 'Erroneous Visit'.
Thank you.
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-04-2021 06:30:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986216
Page 164 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-03-2021 14:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Feb-03-2021 14:58:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-28-2021 10:55:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please provide a
response to Item #3 as
"Not Applicable".
Thank you.
Jan-27-2021 10:08:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered visit marked as
erroneous
Jan-25-2021 03:51:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please complete
this item. Thank you.
Jan-13-2021 15:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Entered in error
Jan-13-2021 11:09:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986217
Page 165 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021 16:07:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-04-2021 10:02:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Jan-27-2021 10:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Jan-13-2021 15:31:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Cleared per query
request
Jan-13-2021 11:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021 16:07:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-04-2021 10:02:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Jan-27-2021 10:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Jan-13-2021 15:31:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Cleared per query
request
Jan-13-2021 11:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-11-2021 16:07:00 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986218
Page 166 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern Time
(US & Canada)Not Applicable
Feb-04-2021 10:02:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Feb-04-2021 10:02:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Jan-28-2021 10:53:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Open query present
Jan-27-2021 10:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Jan-27-2021 10:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Jan-27-2021 10:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
Jan-25-2021 03:52:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Please complete
details on this form.
Thank you.
Jan-13-2021 15:31:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Cleared per query
request
Jan-13-2021 11:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 11:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-13-2021 11:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986219
Page 167 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov/13/2020
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-11-2021 16:07:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Feb-11-2021 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Feb-11-2021 15:57:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN0Transcription Error
Jan-13-2021 15:32:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN0cleared per query
request (DELETED)
Jan-13-2021 11:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-11-2021 15:57:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-11-2021 15:57:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN0Transcription Error
Jan-13-2021 15:32:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN0cleared per query
request (DELETED)
Jan-13-2021 11:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN0Initial Entry
5.b
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986220
Page 168 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-11-2021 15:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Feb-11-2021 15:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN1Transcription Error
Jan-13-2021 15:32:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN1Transcription Error
(DELETED)
Jan-13-2021 11:15:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBN1Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-11-2021 15:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-11-2021 15:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN1Transcription Error
Jan-13-2021 15:32:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN1Transcription Error
(DELETED)
Jan-13-2021 11:15:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBN1Initial Entry
5.c
Date Location User Value Reason
Feb-11-2021 15:58:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID:Transcription Error
Feb-11-2021 15:57:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DHKTranscription Error
Jan-13-2021 15:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DHKTranscription Error
(DELETED)
Jan-13-2021 11:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8DHKInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986221
Page 169 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit on
Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Feb-11-2021 15:58:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-11-2021 15:57:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DHKTranscription Error
Jan-13-2021 15:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DHKTranscription Error
(DELETED)
Jan-13-2021 11:16:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP8DHKInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986222
Page 170 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986223
Page 171 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986224
Page 172 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986225
Page 173 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986226
Page 174 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-03-2020
02:36:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 5:
ClosedResponse satisfies query
Dec-02-2020
09:45:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5:
AnsweredNew Information
Dec-02-2020
09:45:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Worsenin
g of Chro
nic Spasti
c Parapar
esisNew Information
Nov-24-2020
13:45:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 5:
OpenedThe AE Chronic Spastic
Paraparesis was reported but is
also listed in Medical History.
Please clarify if this is a
worsening of the baseline
condition, and if so, please
consider adding "worsening" to
the AE term. AE as baseline
conditions should only be
reported as AEs if they worsen.
"[vathm SDQ=61408]"
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0986227
Page 175 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-24-2020
09:21:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 4:
ClosedResponse satisfies query
Nov-23-2020
15:32:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
AnsweredMed Hx updated accordingly
Nov-23-2020
10:00:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 4:
Reissued:
OpenedMEd Hx has been unfrozen.
Thank you.
Nov-20-2020
10:49:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
AnsweredKindly unlock the Medhx CRF
Nov-19-2020
19:04:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 4:
OpenedIn the narrative the causality is
attributed to underlying
neurological conditions and the
event term is recorded as
"chronic". However, this
information is not recorded in
Med HX. Please revise and
update accordingly.
Nov-17-2020
19:34:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
Closedevent added as AE#3
Nov-17-2020
15:32:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
AnsweredChanged Information
Nov-17-2020
15:32:32
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Data Ent
ry:
Chronic S
pastic ParChanged Information
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986228
Page 176 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US &
Canada)aparesis
Nov-17-2020
05:37:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 3:
OpenedSAE
RECON:AER#2020449153,the
term was updated to
'worsening diagnosis was
spastic paraparesis'
however,event VISUAL
IMPAIRMENT is still reported
as a serious event in Safety
database.Please confirm if
event should be added back in
AE CRF
Nov-17-2020
05:29:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Closedto revised query text
Nov-17-2020
01:13:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedSAE RECON:
AER#2020449153,the term
was updated to 'worsening
diagnosis was spastic
paraparesis' in AE CRF. Please
confirm if a follow up SAE
form was submitted to update
term in Safety database.
Nov-16-2020
13:04:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Giselle Castillo Query 1:
ClosedThank you for the prompt
resolution.
Nov-16-2020
12:20:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answeredupdated per sd
Nov-16-2020
12:20:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
working d
iagnosis
was spasti
c parapar
esisupdated per sd
Nov-15-2020
11:33:39ACV0PFEINFP6000 Giselle Castillo Query 1:
OpenedPer case narrative, subject has
"working diagnosis was spastic
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986229
Page 177 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00)
Eastern Time
(US &
Canada)paraparesis". If this is
considered the final SAE,
please revise and update AE
log accordingly. Thank you.
Nov-13-2020
16:10:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
change in
visual per
ceptionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021 23:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-10-2021 14:46:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Adverse event remains
ongoing and subject is
no longer in the study.
No further follow-up
with this subject is
planned.
Mar-10-2021 12:59:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition Follow-up
form is completed and
this Adverse Event is
still ongoing. Please
review and update as
appropriate.
Dec-02-2020 23:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 09:49:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This was an ongoing
issue prior to subject
enrollment and is
medical history,
however it worsened
during participation
and remains ongoing.
Dec-02-2020 09:48:13
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition Follow-up
form is completed and
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986230
Page 178 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) this Adverse Event is
still ongoing. Please
review and update as
appropriate.
Nov-17-2020 15:33:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged Information
Nov-17-2020 13:58:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/9/2020 UNK:UNKNew Information
Nov-16-2020 12:27:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/8/2020 10:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-04-2020 08:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-02-2020 09:46:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE Worsening of
Chronic Spastic
Paraparesis: Response
to "Is the adverse event
serious?" is 'No' but
"Serious Adverse Event
Number" is present.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986231
Page 179 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-02-2020 09:46:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOSubject was admitted
for change in visual
perception and short
term memory loss, not
for spastic paraparesis.
This is not an SAE.
Nov-14-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE change in
visual perception :
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolon
g hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious even
t
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986232
Page 180 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), this
event is due to:
OTHER
If Other, specify:
Unknown at this timeInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 05:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed SDB action taken updated
Nov-16-2020 13:30:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies query
Nov-16-2020 12:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered EOT crf updated
Nov-14-2020 11:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened SAE
RECON:AER#2020449153 ,action
taken was reported as DRUG
WITHDRAWN in AE CRF while
NOT APPLICABLE in Safety
database.Please confirm. If safety
update is required, please submit a
follow up form
Nov-14-2020 11:05:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed invalid
Nov-14-2020 11:05:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed incorrect query text
Nov-14-2020 11:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened to correct query text
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986233
Page 181 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-14-2020 11:02:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020449153<
short term memory loss>,action
taken was reported as DRUG
WITHDRAWN in AE CRF while
NOT APPLICABLE in Safety
database.Please confirm. If safety
update is required, please submit a
follow up form
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986234
Page 182 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-14-2020 07:36:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened Clin: This AE is listed
to have drug
withdrawn, however,
the EOT page is blank.
please review and
update as appropriate.
thanks
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Dec-04-2020
08:20:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Clo
seddowngraded to non serious
Dec-04-2020
00:44:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Rei
ssued:
Candi
datePending SDB update
Dec-02-2020
09:47:10
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query
6: Ans
weredUpdated SAE form will be sent over
today with this corrected. This is
ongoing, other AE's that were
considered SAE's are resolved.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986235
Page 183 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US &
Canada)
Nov-19-2020
06:24:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
6: Op
enedSAE
RECON:AER#2020449153,outcome
in AE CRF was updated to NOT
RECOVERED/NOT RESOLVED.
per PSSR confirmation outcome 'In
the SAE form received, only
“chronic spastic paraparesis” was
mentioned to have recovered on
09Nov2020. Please confirm correct
outcome
Nov-18-2020
12:00:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Clo
sedResponse satisfies query
Nov-18-2020
09:30:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
5: Ans
weredTranscription Error
Nov-18-2020
09:30:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOT
RECO
VERE
D/NO
T RE
SOLV
EDTranscription Error
Nov-17-2020
21:32:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
5: Op
enedDMW5406414;Response to "What
was the outcome of this adverse
event?" is 'Recovered/Resolved' or
'Recovered/Resolved with Sequelae'
but End Date/Time is missing.
Please review and update as
appropriate.
Nov-17-2020
19:36:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Nov-17-2020 ACV0PFEINFP6000 auto query QueryClose Auto Query
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986236
Page 184 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14:01:13
(UTC-05:00)
Eastern Time
(US &
Canada)(autoquery) 4: Clo
sed
Nov-17-2020
14:01:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredNew Information
Nov-17-2020
14:01:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
RECO
VERE
D/RE
SOLV
EDNew Information
Nov-17-2020
13:58:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: Op
enedFor AE working diagnosis was
spastic paraparesis: Response to
"What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-17-2020
05:43:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedSAE RECON:AER#2020449153,per
PSSR confirmation outcome 'In the
SAE form received, only “chronic
spastic paraparesis” was mentioned
to have recovered on 09Nov2020. '.
Please confirm if outcome should be
updated to
RECOVERED/RESOLVED in AE
CRF.
Nov-17-2020
01:00:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedissue resolved
Nov-16-2020
12:27:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Nov-16-2020
12:20:42ACV0PFEINFP6000 auto query
(autoquery)Query
2: OpFor AE working diagnosis was
spastic paraparesis: Response to
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986237
Page 185 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00)
Eastern Time
(US &
Canada)ened"What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-16-2020
12:15:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedFor AE change in visual perception :
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-16-2020
12:15:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Nov-16-2020
12:15:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
RECO
VERI
NG/R
ESOL
VINGTranscription Error
Nov-14-2020
11:03:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2020449153,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-13-2020
16:10:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
RECO
VERE
D/RE
SOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 16:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986238
Page 186 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-04-2020 08:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: downgraded to non
serious
Nov-14-2020 10:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020449153Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986239
Page 187 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
short term memory lossInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 16:42:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-23-2021 09:55:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Jan-25-2021 11:36:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Per progress note dated
13 Nov 2020, subject
noted that they had
Bilateral Eye Pain.
Please consider if
'Bilateral Eye Pain'
should be captured as a
separate AE. If so,
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986240
Page 188 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
please update AE Log
and update Inform and
upload source to
Florence. Thank you.
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/10/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:52:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Nov-19-2020 15:37:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Per SD subject was not
tested for COVID-19
when hospitalized.
Follow-up SAE has
been faxed.
Nov-19-2020 14:39:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened As per the request of
our Data Monitoring
Committee, please
include in a follow-up
SAE form whether
COVID testing was
conducted during
hospitalization – yes/no
including not
available/not
performed. If COVID
testing was performed,
include the results.
Nov-14-2020 10:59:41
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0986241
Page 189 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE short term
memory loss: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolo
ng hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious eve
nt
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), thisInitial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986242
Page 190 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
event is due to:
OTHER
If Other, specify:
unknown at this time
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 05:25:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed SDB action taken updated to
drug withdrawn
Nov-16-2020 13:35:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Closed Response satisfies query
Nov-16-2020 12:27:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered EOT has been updated
Nov-14-2020 11:06:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020449153<
short term memory
loss>,action taken was
reported as DRUG
WITHDRAWN in AE CRF
while NOT APPLICABLE
in Safety database.Please
confirm. If safety update is
required, please submit a
follow up form
Nov-14-2020 07:37:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Ahmed
HassanQuery 1: Opened Clin: This AE is listed to
have drug withdrawn,
however, the EOT page is
blank. please review and
update as appropriate. thanks
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986243
Page 191 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-17-2020 19:52:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per PSSR confirmation 'For this
SAE change in visual perception,
short term memory loss, we received
a new follow-up report with the
updated outcome (Recovered)'. issue
resolved
Nov-17-2020 00:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate pending SDB update
Nov-16-2020 12:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated SAE follow up is to be
faxed
Nov-14-2020 11:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020449153,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-13-2020 16:11:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 16:11:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-14-2020 10:59:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020449153Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986244
Page 192 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Change in Visual PerceptionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 14:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/9/2020 10:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986245
Page 193 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-17-2020 19:32:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Change in
Visual Perception:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with co
ngenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolon
g hospitalization?
YES
Did this serious event result in persiste
nt or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious even
t
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986246
Page 194 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Spontaneous resolution, cause is u
nknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986247
Page 195 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-03-2020 20:07:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 09:49:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Nov-23-2020 06:39:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Change in
Visual Perception: Is
listed to have caused
study discontinuation,
however, the FUP page
is blank. Please
review/update as
appropriate. Thanks
Nov-22-2020 19:51:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery: Change in
Visual Perception: Is
listed to have caused
study discontinuation,
however, the FUP page
is blank. Please
review/update as
appropriate. Thanks
Nov-17-2020 15:34:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-17-2020 19:32:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020449153Initial Entry
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986248
Page 196 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral Eye PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021
22:44:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Clo
sedAuto closed by Validation
Check: VC_AE001_10_AN
Mar-10-2021
14:47:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredFUP form updated
Mar-10-2021
06:54:47
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 1: Rei
ssued:Opene
dDM: Form unfrozen, Please
update per query response
provided.
090177e196ae30f4\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0986249
Page 197 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401306 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
Mar-09-2021
15:38:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredPlease unlock FUP CRF in
order to udpate the date
Mar-09-2021
13:53:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Rei
ssued:Opene
dthank you for your
response! Since resolution
date is provided and a
follow up took place, FUP
date should be updated
accordingly to reflect this
date 01JAN2021 or when
this information was
obtained actually per
source. Thank you!
Mar-08-2021
12:34:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredResolution date of
01Jan2021 matches source
and is correct, however
please advise if this date
should match disposition
date.
Feb-24-2021
07:12:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 1: Op
enedDMW7403063;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Feb-23-2021
09:55:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date T
ime:
Jan/1/202
1 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-23-2021 09:55:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prol
…[truncated]