Document text
Page 1 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984306
Page 2 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Aug/6/2020
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984307
Page 3 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11401066]
2.Birth Date: /1953
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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984308
Page 4 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/6/2020
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984309
Page 5 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984310
Page 6 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984311
Page 7 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:[hyperlipidemia]
Start Date: Aug/1/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[elevated (htn) blood pressure]
Start Date: Oct/1/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia (sleep disorder)]
Start Date: Oct/1/2017
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[erectile dysfunction]
Start Date: Oct/1/2016
Ongoing: YES
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984312
Page 8 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[umbilical hernia repair]
Start Date: Aug/1/2018
Ongoing: NO
End Date:
Aug/1/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic fatigue]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lymphadenopathy]
Start Date: May/UNK/2020
Ongoing: YES
1 hLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984313
Page 9 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/6/2020
2.Weight: [279.4]
3.Unit: LB
4.Height: [72.76]
5.Unit: in
6.Body Mass Index: [37.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984314
Page 10 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/6/2020
2.Randomization Number: [223449]
3.Randomization Group: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984315
Page 11 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:
Aug/6/2020
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 [BNB48D]
5.bSample ID [BNB48F]
5.cSample ID [BNB48G]
5.dSample ID [BPG5C5]
5.eSample ID [BPG5C6]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984316
Page 12 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:
Aug/6/2020
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 [BNB48H]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984317
Page 13 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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: Aug/6/2020 14:47
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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984318
Page 14 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984319
Page 15 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984320
Page 16 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984321
Page 17 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984322
Page 18 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984323
Page 19 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:
Aug/25/2020
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 [BNB4FL]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984324
Page 20 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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: Aug/25/2020 11:34
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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984325
Page 21 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984326
Page 22 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984327
Page 23 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984328
Page 24 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:
Sep/23/2020
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 [BPYZ74]
5.bSample ID [BPG5LZ]
5.cSample ID [BPG5M0]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984329
Page 25 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984330
Page 26 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 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:
Mar/9/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTWSRG]
5.bSample ID [BVV2CH]
5.cSample ID [BVV2CJ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984331
Page 27 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984332
Page 28 of 212
***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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984333
Page 29 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984334
Page 30 of 212
***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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984335
Page 31 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984336
Page 32 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984337
Page 33 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984338
Page 34 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984339
Page 35 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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?
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984340
Page 36 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 11401066 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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984341
Page 37 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984342
Page 38 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984343
Page 39 of 212
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984344
Page 40 of 212
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984345
Page 41 of 212
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984346
Page 42 of 212
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984347
Page 43 of 212
***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: 11401066 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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984348
Page 44 of 212
***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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984349
Page 45 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 thyroid cancer Aug/30/2020 1
1:00 YES Repeating
Pages
2. ADVERSE
EVENT 2 Total Thyroidecto
my Oct/30/2020 U
NK:UNK NO
End Date Time:
Oct/30/2020 UNK:
UNK
Repeating
Pages
3. ADVERSE
EVENT 3 Radioactive Iodin
e Treatment Feb/8/2021 UN
K:UNK NO
End Date Time:
Feb/8/2021 UNK:U
NK
Repeating
Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984350
Page 46 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[thyroid cancer ]
4.Start Date Time: Aug/30/2020 11:00
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).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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984351
Page 47 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[malignant mass ]
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?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020370603 ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984352
Page 48 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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)[Total Thyroidectomy]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Thyroid cancer]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984353
Page 49 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984354
Page 50 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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)[Radioactive Iodine Treatment]
4.Start Date Time: Feb/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/8/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Thyroid Cancer Treatment]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984355
Page 51 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984356
Page 52 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryMedication
ErrorStart DateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1.Not Applic
able Not Applicab
le Not Applic
able Not Applicable Not Applicable Repeating
Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984357
Page 53 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause
the subject to be discontinued
from the study?Not Applicable Comments
9.Was this medication error
associated with any adverse
events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984358
Page 54 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984359
Page 55 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984360
Page 56 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Applica
ble Repeating
Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984361
Page 57 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984362
Page 58 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatment Start Date Form Instance
1.Not Applica
ble Not Applicable Not Applicable Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984363
Page 59 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984364
Page 60 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984365
Page 61 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984366
Page 62 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984367
Page 63 of 212
***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: 11401066 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:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984368
Page 64 of 212
***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: 11401066 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?
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984369
Page 65 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984370
Page 66 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984371
Page 67 of 212
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984372
Page 68 of 212
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984373
Page 69 of 212
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984374
Page 70 of 212
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11401066 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 [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984375
Page 71 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984376
Page 72 of 212
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984377
Page 73 of 212
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984378
Page 74 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984379
Page 75 of 212
***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: 11401066 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: [ ]
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984380
Page 76 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/23/2020
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984381
Page 77 of 212
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984382
Page 78 of 212
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-11-2021 20:17:46 (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.
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0984383
Page 79 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-06-2020 15:41:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984384
Page 80 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984385
Page 81 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984386
Page 82 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984387
Page 83 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984388
Page 84 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984389
Page 85 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984390
Page 86 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984391
Page 87 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984392
Page 88 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984393
Page 89 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984394
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
FormOct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
1Oct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
2Oct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
3Oct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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ItemDate User Comment
4Oct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 13:24:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
10Oct-13-2020 13:24:28 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0984418
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Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Oct-13-2020 13:24:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0984419
Page 115 of 212
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Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormOct-13-2020 13:24:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Oct-13-2020 13:24:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Oct-13-2020 13:24:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0984422
Page 118 of 212
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Name Signature
MeaningDate Type Action
Stephen
Thomas Approved Mar-11-2021 20:17:46 (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 Feb-10-2021 14:34:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Oct-13-2020 20:09:30 (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 Oct-13-2020 13:23:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984423
Page 119 of 212
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Stephen
Thomas Approved Oct-12-2020 09:20:53 (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 Sep-24-2020 13:25:07 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-24-2020 11:17:15 (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 Sep-24-2020 10:13:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-23-2020 16:32:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984424
Page 120 of 212
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 Sep-23-2020 14:07:04 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Thomas Approved Sep-17-2020 20:19:28 (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.
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0984425
Page 121 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Aug-06-2020 15:37:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-06-2020 15:37:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984426
Page 122 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-06-2020 15:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/6/2020Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984427
Page 123 of 212
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-06-2020 15:37:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11401066Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-06-2020 15:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-06-2020 15:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-06-2020 15:41:33
(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
Aug-06-2020 15:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(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-2021-5683-0984428
Page 124 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-06-2020 15:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984429
Page 125 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Aug-06-2020 15:42:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-06-2020 15:42:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-06-2020 15:42:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984430
Page 126 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020 15:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hyperlipide
mia
Start Date: Aug/1/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:42:42
(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-08-2020 13:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Katherine
PuigQuery 1: Deleted Timeframe exceeded
for data correction
period. Data may
now be
refrozen/relocked.
Site may reach out
again if further data
corrections needed.
Sep-28-2020 22:44:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Katherine
PuigQuery 1: Candidate DM: Site request to
add Thyroid
Cancer/Thyroid
Mass. Please do not
raise query to site.
Candidate query
may be closed once
MH entered.
Aug-06-2020 15:42:42 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0984431
Page 127 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern
Time (US & Canada)hyperlipidemia
1.a Start Date:
Date Location User Value Reason
Aug-06-2020 15:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-06-2020 15:42:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-06-2020 15:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:elevated (htn) bl
ood pressure
Start Date: Oct/1/2017
Ongoing: YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984432
Page 128 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:43:12
(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
Aug-06-2020 15:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated (htn) blood pressureInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020 15:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020 15:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-06-2020 15:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:insomnia (sleep
disorder)
Start Date: Oct/1/2017
Ongoing: YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984433
Page 129 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:43:39
(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
Aug-06-2020 15:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
insomnia (sleep disorder)Initial Entry
1.c Start Date:
Date Location User Value Reason
Aug-06-2020 15:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-06-2020 15:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-06-2020 15:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:erectile dysfu
nction
Start Date: Oct/1/2016
Ongoing: YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984434
Page 130 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:44:05
(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
Aug-06-2020 15:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
erectile dysfunctionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-06-2020 15:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-06-2020 15:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-06-2020 15:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:umbilical hernia
repair
Start Date: Aug/1/2018
Ongoing: NO
End Date:
Aug/1/2018Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984435
Page 131 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:44:39
(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
Aug-06-2020 15:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
umbilical hernia repairInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-06-2020 15:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-06-2020 15:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Aug/1/2018Initial Entry
1.f
Date Location User Value Reason
Sep-29-2020 14:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:chronic fatig
ue
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984436
Page 132 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-29-2020 14:40:57
(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-02-2020 20:23:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-01-2020 13:26:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Reason unknown,
no definitive
diagnosis available
Sep-30-2020 20:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: chronic
fatigue: Please can
you update to
indicate a
diagnosis, if
known? Thanks
Sep-29-2020 14:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chronic fatigueInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-29-2020 14:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-29-2020 14:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984437
Page 133 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g
Date Location User Value Reason
Sep-29-2020 14:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:lymphadenop
athy
Start Date: May/UNK/20
20
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Sep-29-2020 14:41:33
(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
Sep-29-2020 14:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
lymphadenopathyInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-29-2020 14:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-29-2020 14:41:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984438
Page 134 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
279.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
72.76Initial Entry
5. Unit:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984439
Page 135 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
37.1Initial Entry
7.a
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984440
Page 136 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-06-2020 15:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984441
Page 137 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-06-2020 15:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-06-2020 15:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
223449Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984442
Page 138 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 15:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 15:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020 10:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-07-2020 04:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query:
'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-06-2020 15:45:33
(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.
Aug-06-2020 15:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0984443
Page 139 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug/6/2020
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-14-2020 01:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-11-2020 09:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered UPDATED PER
SD
Aug-11-2020 07:51:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Subject is listed to
have:3 serum
samples, which is
less than the 5
expected. Please
review and update
Q4 as appropriate,
else clarify.
5.a
Date Location User Value Reason
Aug-07-2020 10:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB48DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 10:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB48DInitial Entry
5.b
Date Location User Value Reason
Aug-07-2020 10:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB48FInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984444
Page 140 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Sample ID
Date Location User Value Reason
Aug-07-2020 10:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB48FInitial Entry
5.c
Date Location User Value Reason
Aug-07-2020 10:38:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB48GInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-07-2020 10:38:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB48GInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020 09:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5C5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-11-2020 09:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5C5Initial Entry
5.e
Date Location User Value Reason
Aug-11-2020 09:57:22
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BPG5C6Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984445
Page 141 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
5.e Sample ID
Date Location User Value Reason
Aug-11-2020 09:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5C6Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984446
Page 142 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 15:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 15:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 13:47:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-07-2020 04:27:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query:
'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-06-2020 15:45:39
(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.
Aug-06-2020 15:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0984447
Page 143 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug/6/2020
5.a
Date Location User Value Reason
Aug-10-2020 13:47:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNB48HInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 13:47:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB48HInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984448
Page 144 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/6/2020 14:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984449
Page 145 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-06-2020 15:50:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984450
Page 146 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Sep-09-2020 09:52:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
response.
Sep-08-2020 16:26:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject's Vax2 eDiary
was activated on the
day of the visit.
However, Subject has
not completed vax2
assessments.
Sep-03-2020 03:31:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sagaya Mythili Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 2
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-07-2020 15:50:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(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-2021-5683-0984451
Page 147 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 12:53:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984452
Page 148 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984453
Page 149 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984454
Page 150 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984455
Page 151 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.e
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984456
Page 152 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984457
Page 153 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984458
Page 154 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984459
Page 155 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984460
Page 156 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:53:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984461
Page 157 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2.a
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984462
Page 158 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 12:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984463
Page 159 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 16:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 12:53:56
(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.
Aug-25-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 16:33:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BNB4FLInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984464
Page 160 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 16:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNB4FLInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984465
Page 161 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 11:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984466
Page 162 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984467
Page 163 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 10:13:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984468
Page 164 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984469
Page 165 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984470
Page 166 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984471
Page 167 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.e
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984472
Page 168 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984473
Page 169 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984474
Page 170 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984475
Page 171 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984476
Page 172 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-24-2020 10:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984477
Page 173 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 10:14:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 10:14:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 10:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 10:14:20
(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.
Sep-24-2020 10:14:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 10:14:53
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Sample ID: BPYZ74Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984478
Page 174 of 212
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 10:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYZ74Initial Entry
5.b
Date Location User Value Reason
Sep-24-2020 10:15:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5LZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-24-2020 10:15:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5LZInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020 10:19:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG5M0Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-24-2020 10:19:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG5M0Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984479
Page 175 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-11-2021
01:16:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedClosed per SITE
response, added
to PD tracker for
Clinical Review.
Mar-10-2021
09:21:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dORIGINAL
DATE
RECORDED IS
CORRECT.
SUBJECT HAD
CALLED IN
AND
RESCHEDULED
DUE TO HIS AE
Mar-10-2021
06:14:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of
visit at
V4_MONTH6_L
is out of window
for 7 days from
V2_VAX2_L
DOV or V2
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
Mar-09-2021
12:32:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Mar/9
/2021Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0984480
Page 176 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 12:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 12:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 09:22:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 06:57:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-09-2021 12:32:38
(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.
Mar-09-2021 12:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984481
Page 177 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Mar-10-2021 09:22:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTWSRGInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 09:22:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTWSRGInitial Entry
5.b
Date Location User Value Reason
Mar-10-2021 09:22:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BVV2CHInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021 09:22:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BVV2CHInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021 09:22:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BVV2CJInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984482
Page 178 of 212
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Mar-10-2021 09:22:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BVV2CJInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984483
Page 179 of 212
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 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-06-2020 13:03:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Transcription Error
Sep-25-2020 10:40:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 10:40:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 10:40:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984484
Page 180 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-01-2020 13:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984485
Page 181 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984486
Page 182 of 212
***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: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984487
Page 183 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 14:07:04
(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
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
thyroid cancerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/30/2020 11:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984488
Page 184 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-23-2020 14:07:04
(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
Oct-02-2020
08:11:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Oct-01-2020
13:25:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Oct-01-2020
07:03:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020370603,event
Thyroid Cancer was invalidated
in SDB but still recorded in AE
CRF.Per email confirmation'The
PI confirmed with the subject
that the Thyroid Cancer occurred
prior to enrollment / 2018'.Please
confirm if event is for deletion
Sep-24-2020
13:25:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020
14:07:04
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE thyroid cancer: Response
to "Is the adverse event serious?"
is 'Yes' but "Serious Adverse
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0984489
Page 185 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Eastern Time (US &
Canada)Event Number" is blank.
Sep-23-2020
14:07:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bir
th defect?
NO
Did this serious even
t result in death?
NO
Did this serious even
t require or prolong h
ospitalization?
NO
Did this serious even
t result in persistent
or significant disabili
ty/incapacity?
NO
Is this serious event l
ife threatening?
NO
Other medically imp
ortant serious event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984490
Page 186 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep-23-2020 14:07:04
(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
Oct-02-2020 14:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-02-2020 10:30:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candida
teThank you
Oct-01-2020 13:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-30-2020
15:21:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened AE log is now
unfrozen. Thank you.
Sep-30-2020
15:21:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Placed on different
log.
Sep-30-2020
15:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened AE log is now
unfrozen. Thank you.
Sep-29-2020
14:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered SAE no longer
applicable since
event began prior to
consent. No
exclusion criteria met
with regard to
medications or
radiotherapy. Please
unlock row so SAE
can be deleted.
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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)
FDA-CBER-2021-5683-0984491
Page 187 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Updated form faxed
to DSU
Sep-28-2020
18:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Specific type or
treatment have not
been recorded. Since
"immunosuppressant
medications, or
radiotherapy, within
60 days before
enrollment through
conclusion of the
study" are prohibited,
please revise or
update with SAE
form if possible.
Thank you.
Sep-23-2020
14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
malignant massInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984492
Page 188 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 14:07:04
(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
Sep-23-2020 14:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 14:07:04
(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
Sep-24-2020 13:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020370603Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984493
Page 189 of 212
***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, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 12:34:48
(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
Mar-12-2021 15:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Procedures should
not be reported as
Adverse Events;
However the
underlying
condition should be
reported. Please
report the
underlying
condition along
with associated
information instead
of the procedure.
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Total ThyroidectomyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 12:34:48 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984494
Page 190 of 212
***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, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00) Eastern
Time (US & Canada)Oct/30/2020 UNK:UNK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984495
Page 191 of 212
***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, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Mar-12-2021
15:46:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Cand
idateOnce AE Term
is updated from
the total
Thyroidectomy
(procedure) to
an actual AE -
ensure the start
date and stop
date was
updated too for
the Thyroid
cancer that is
what it should
be. Thank you
3/12/21
Mar-12-2021
10:34:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redSubject was
diagnosed with
thyroid cancer
AFTER
enrollment, this
was not a
known
pre-existing
event.
Mar-12-2021
08:14:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [Thyroid
cancer]. Kindly
confirm this
condition is
related to any
pre existing
event, if so
please review
and update the
Medical
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0984496
Page 192 of 212
***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, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
History, else
clarify. "[ks66
SDQ=156781]"
Mar-09-2021
12:34:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
T
h
yr
oi
d
ca
n
ce
rInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 12:34:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984497
Page 193 of 212
***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, Queries
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 12:34:48
(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
Mar-09-2021 12:34:48
(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
Mar-09-2021 12:34:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984498
Page 194 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 12:36:47
(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
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Radioactive Iodine TreatmentInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/8/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/8/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984499
Page 195 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021 12:36:47
(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
Mar-12-2021
16:16:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Cand
idateClinical -
please review
this subject for
further
guidance as
treatment and
procedures
should not be
reported as
AE's - Thank
You!
Mar-12-2021
10:35:02ACV0PFEINFP6000 Query 1
: AnsweSubject was
diagnosed with
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984500
Page 196 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-05:00)
Eastern Time
(US &
Canada)red thyroid cancer
AFTER
enrollment, this
was not a
known
pre-existing
condition
Mar-12-2021
08:09:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [Thyroid
Cancer].Kindly
confirm this
condition is
related to any
pre existing
event, if so
please review
and update the
Medical
History, else
clarify. "[ks66
SDQ=156810]"
Mar-09-2021
12:36:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTHInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0984501
Page 197 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
ER
If O
ther
, sp
ecif
y:
T
h
yr
oi
d
C
an
ce
r
Tr
ea
t
m
en
t
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 12:36:47
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984502
Page 198 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021 12:36:47
(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
Mar-09-2021 12:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0984503
Page 199 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984504
Page 200 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-13-2020 13:23:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984505
Page 201 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-13-2020 13:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Oct-13-2020 13:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-13-2020 13:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s),
route, use, formulation).
Date Location User Value Reason
Oct-13-2020 13:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Oct-13-2020 13:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984506
Page 202 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s),
route, use, formulation).
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30f5\Final\Final On: 01-Apr-2021 04:21 (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-2021-5683-0984507
Page 203 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1140 Site Name: (1140) SUNY Upstate Medical University
Subject No: 11401066 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Dose Unit:
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Oct-13-2020 13:24:28
(UTC-0
…[truncated]