Document text
Page 1 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889123
Page 2 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/30/2020
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889124
Page 3 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315404]
2.Birth Date: 1941
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889125
Page 4 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/30/2020
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889126
Page 5 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889127
Page 6 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889128
Page 7 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial Hypertension]
Start Date: Aug/1/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arrhytmia. Origin unknown]
Start Date: Dec/1/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[partial thyroidectomy]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889129
Page 8 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depressive syndrome]
Start Date: UNK/UNK/2002
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hematuria]
Start Date: Jun/2/2020
Ongoing: YES
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889130
Page 9 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/30/2020
2.Weight: [82.0]
3.Unit: kg
4.Height: [151.0]
5.Unit: cm
6.Body Mass Index: [36.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889131
Page 10 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889132
Page 11 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/30/2020
2.Randomization Number: [246206]
3.Randomization Group: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889133
Page 12 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BP25D5]
5.bSample ID [BP25D6]
5.cSample ID [BP25D7]
5.dSample ID [BLBJ86]
5.eSample ID [BLBJ87]
5 fSample ID [BLBJ88]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889134
Page 13 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BPT8HR]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889135
Page 14 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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/30/2020 10:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889136
Page 15 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889137
Page 16 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889138
Page 17 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889139
Page 18 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889140
Page 19 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXWYX]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889141
Page 20 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/19/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/8/2020 18:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889142
Page 21 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889143
Page 22 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BJ4DVX]
5.bSample ID [BJ4DXV]
5.cSample ID [BP1P80]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889144
Page 23 of 178
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889145
Page 24 of 178
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889146
Page 25 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889147
Page 26 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889148
Page 27 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889149
Page 28 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889150
Page 29 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889151
Page 30 of 178
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889152
Page 31 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889153
Page 32 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889154
Page 33 of 178
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889155
Page 34 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889156
Page 35 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889157
Page 36 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889158
Page 37 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889159
Page 38 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889160
Page 39 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889161
Page 40 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889162
Page 41 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889163
Page 42 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889164
Page 43 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889165
Page 44 of 178
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889166
Page 45 of 178
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889167
Page 46 of 178
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889168
Page 47 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889169
Page 48 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889170
Page 49 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889171
Page 50 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889172
Page 51 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889173
Page 52 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889174
Page 53 of 178
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889175
Page 54 of 178
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889176
Page 55 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Uncomplicated urinary infec
tion Aug/31/2020
14:50 NO
End Date Time:
Oct/2/2020 08:00
Repeating
Pages
2.ADVERSE E
VENT 2 Exacerbation of gross hemat
uria Oct/11/2020
08:00 NO
End Date Time:
Dec/29/2020 17:59
Repeating
Pages
3.ADVERSE E
VENT 3 High grade infiltrating uroth
elial carcinoma Dec/29/2020
18:00 YES Repeating
Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889177
Page 56 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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)[Uncomplicated urinary infection]
4.Start Date Time: Aug/31/2020 14:50
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889178
Page 57 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[Urinary infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889179
Page 58 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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)[Exacerbation of gross hematuria]
4.Start Date Time: Oct/11/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/29/2020 17:59
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889180
Page 59 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[Unknow]
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[ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889181
Page 60 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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)[High grade infiltrating urothelial carcinoma]
4.Start Date Time: Dec/29/2020 18:00
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
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889182
Page 61 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2021001420]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889183
Page 62 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889184
Page 63 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889185
Page 64 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889186
Page 65 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889187
Page 66 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889188
Page 67 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889189
Page 68 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889190
Page 69 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889191
Page 70 of 178
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889192
Page 71 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889193
Page 72 of 178
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889194
Page 73 of 178
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889195
Page 74 of 178
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889196
Page 75 of 178
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889197
Page 76 of 178
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889198
Page 77 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889199
Page 78 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889200
Page 79 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889201
Page 80 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 13:05:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889202
Page 81 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889203
Page 82 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Aug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889204
Page 83 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Aug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889205
Page 84 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Aug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889206
Page 85 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Aug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889207
Page 86 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Aug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889208
Page 87 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889209
Page 88 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889210
Page 89 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aAug-30-2020 13:07:46 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889211
Page 90 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormSep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889212
Page 91 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Sep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889213
Page 92 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Sep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889214
Page 93 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Sep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889215
Page 94 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Sep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889216
Page 95 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Sep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889217
Page 96 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aSep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889218
Page 97 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aSep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889219
Page 98 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aSep-19-2020 11:02:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889220
Page 99 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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 Mar-24-2021 10:26:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-24-2021 10:13:11 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, 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 Mar-23-2021 15:57:13 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889221
Page 100 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
N/A
Approved Mar-09-2021 16:23:08 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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 Mar-09-2021 08:19:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 15:59:53 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-05-2021 11:21:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889222
Page 101 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Approved Nov-12-2020 18:19:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 09:17:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 15:03:06 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889223
Page 102 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-30-2020 13:04:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-30-2020 13:04:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889224
Page 103 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-30-2020 13:04:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/30/2020Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889225
Page 104 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-30-2020 09:31:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12315404Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-30-2020 09:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1941Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-30-2020 13:05:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-30-2020 13:05:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-30-2020 13:05:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889226
Page 105 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-30-2020 13:05:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889227
Page 106 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-30-2020 13:06:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-30-2020 13:06:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-30-2020 13:06:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889228
Page 107 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Aug-30-2020 13:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Arterial Hyper
tension
Start Date: Aug/1/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-30-2020 13:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-13-2021 02:11:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-07-2021 17:53:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Med Hx was
updated
Jan-07-2021 11:19:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL Per
SAE report,
subject had an
episode of
macroscopic
hematuria prior to
study entry
(02Jun2020);
however, this is not
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889229
Page 108 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
recorded on Med
Hx. Please review
for clinical
relevance to safety
event, and update
Med Hx as
applicable
Aug-30-2020 13:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Arterial HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-30-2020 13:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/1/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-30-2020 13:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-30-2020 13:07:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Arrhytmia. Origi
n unknown
Start Date: Dec/1/2019
Ongoing: YESInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889230
Page 109 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b Line/MH Number:
Date Location User Value Reason
Aug-30-2020 13:07:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-30-2020 13:07:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Arrhytmia. Origin unknownInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-30-2020 13:07:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/1/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-30-2020 13:07:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-04-2020 09:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Obesity
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889231
Page 110 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.c Line/MH Number:
Date Location User Value Reason
Nov-04-2020 09:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 09:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-04-2020 09:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-04-2020 09:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-04-2020 09:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:partial thyroide
ctomy
Start Date: UNK/UNK/19
75Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889232
Page 111 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Ongoing: NO
End Date:
UNK/UNK/
1975
1.d Line/MH Number:
Date Location User Value Reason
Nov-04-2020 09:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 09:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
partial thyroidectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-04-2020 09:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-04-2020 09:16:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
1.e
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889233
Page 112 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-04-2020 09:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:depressive syn
drome
Start Date: UNK/UNK/20
02
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Nov-04-2020 09:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 09:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
depressive syndromeInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-04-2020 09:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-04-2020 09:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889234
Page 113 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-08-2021 11:50:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Line/MH Number
:6
Medical History T
erm:hematuri
a
Start Date: Jun/2/20
20
Ongoing: YESInitial Entry
Jan-07-2021 17:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:hematur
ia
Start Date:
Ongoing:Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889235
Page 114 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.f Line/MH Number:
Date Location User Value Reason
Jan-07-2021 17:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-07-2021 17:52:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
hematuriaInitial Entry
1.f Start Date:
Date Location User Value Reason
Jan-11-2021 02:27:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-08-2021 11:50:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-08-2021 11:50:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Jun/2/2020Initial Entry
Jan-08-2021 02:58:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Start Date and
Ongoing" is
missing. Kindly
review and
update.
1.f Ongoing:
Date Location User Value Reason
Jan-08-2021 11:50:53
(UTC-03:00) City ofACV0PFEINFP6000 Santiago
CorradettiData Entry:
YESInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889236
Page 115 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889237
Page 116 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
82.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
151.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889238
Page 117 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.0Initial Entry
7.a
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889239
Page 118 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-30-2020 13:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889240
Page 119 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889241
Page 120 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-30-2020 13:07:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889242
Page 121 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-30-2020 13:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-30-2020 13:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
246206Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889243
Page 122 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 13:08:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 13:08:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 11:04:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 13:08:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-30-2020 13:08:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889244
Page 123 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 11:04:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25D5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 11:04:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25D5Initial Entry
5.b
Date Location User Value Reason
Aug-31-2020 11:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25D6Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 11:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25D6Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020 11:04:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25D7Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 11:04:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25D7Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889245
Page 124 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d
Date Location User Value Reason
Aug-31-2020 16:44:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBJ86Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 16:44:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ86Initial Entry
5.e
Date Location User Value Reason
Aug-31-2020 16:44:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBJ87Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 16:44:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ87Initial Entry
5.f
Date Location User Value Reason
Aug-31-2020 16:44:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBJ88Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889246
Page 125 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.f Sample ID
Date Location User Value Reason
Aug-31-2020 16:44:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBJ88Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889247
Page 126 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 13:08:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 13:08:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 13:08:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-30-2020 13:08:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889248
Page 127 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT8HRInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT8HRInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889249
Page 128 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020 10:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889250
Page 129 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-30-2020 13:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889251
Page 130 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-30-2020 13:08:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889252
Page 131 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 04:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-12-2020 11:14:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-12-2020 11:14:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/8/2020New Information
Sep-30-2020 09:42:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thank you
for the response.
Please keep this
query open at your
end. Once visit is
performed, kindly
update vaccination
details and rest of
the visit pages and
then respond to
the query.
Sep-29-2020 11:56:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered This subject is in a
temporary delay.
No new
information will
be available until
resuming visit.
Thank you.
Sep-26-2020 13:36:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete ‘Nasal
Swab form' at this
visit. Thank you.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889253
Page 132 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-19-2020 11:02:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889254
Page 133 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020 08:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 08:43:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/8/2020Transcription Error
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital Signs Date is
not same as
Vaccination Date in
the same visit.
Please review and
update as
appropriate or
clarify.
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889255
Page 134 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020 11:02:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889256
Page 135 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889257
Page 136 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-19-2020 11:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889258
Page 137 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 11:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 11:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 11:23:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 11:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 11:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889259
Page 138 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-12-2020 11:23:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPXWYXInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 11:23:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPXWYXInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889260
Page 139 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 12:45:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-08-2020 09:55:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered the subject did not
have a history of
hematuria. It
started a day after
V1. Information
loaded on AE form.
Oct-06-2020 13:57:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened CLINQUERY: Did
the subject have a
history or
hematuria prior to
entering the study?
Thank you.
Oct-05-2020 11:08:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Based on medical
history the
physician decided
to delay
vaccination due to
the AE, because it
is still ongoing.
Thank you.
Oct-01-2020 16:50:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened CLIN: Understood
but as noted in
previous query
temporary delay of
vaccination should
only be noted as
yes if one of the
conditions
described in
Section 5.5 are
met. Since
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889261
Page 140 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
haematuria is not
listed there please
update to indicate
there was NOT a
temp delay
Oct-01-2020 11:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Haematuria was
reported as an AE.
Yet undiagnosed.
Sep-30-2020 18:11:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINQUERY:
Temporary delay of
vaccination should
only be noted as
yes if one of the
conditions
described in
Section 5.5 are
met. Since
vaccination was
delayed due to
haematuria please
update to indicated
there was NOT a
temporary delay.
Thank you.
Sep-30-2020 15:13:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-30-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The reason for this
delay is due to
acute disease
"Hematuria", at the
moment he
continues to have a
scheduled
appointment with
urology on 28 Sep
2020. Thank you.
Sep-21-2020 16:56:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY:
temporary delay
due to FEVER OR
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889262
Page 141 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
ACUTE ILLNESS
is reported. In your
response to this
query, please
clarify if the
subject experienced
fever OR acute
illness, and please
include the
temperature and/or
acute illness
details. Thank you.
Sep-19-2020 11:03:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of First Delay:
Sep/19/2020
Reason(s) for Temporary D
elay of Vaccination
FEVER OR ACUTE ILL
NESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889263
Page 142 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/8/2020 18:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-12-2020 11:15:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889264
Page 143 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 09:17:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889265
Page 144 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 09:17:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 09:17:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 10:45:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 09:17:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-12-2020 09:17:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889266
Page 145 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-12-2020 10:45:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4DVXInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 10:45:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4DVXInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020 11:10:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4DXVInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 11:10:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4DXVInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020 12:02:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1P80Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889267
Page 146 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 12:02:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1P80Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889268
Page 147 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 09:17:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 09:17:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 09:17:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889269
Page 148 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889270
Page 149 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889271
Page 150 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889272
Page 151 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-05-2021 11:21:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Uncomplicated urinary infect
ionNew Information
Oct-16-2020 13:39:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
macroscopic haematuriaNew Information
Oct-12-2020 14:20:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-11-2020 21:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Query 1: Answered macroscopic
Oct-08-2020 15:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please clarify if
haematuria was
macroscopic (ie,
blood observed in
urine). Thank you.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889273
Page 152 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
haematuriaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/31/2020 14:50Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-06-2020 08:28:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 08:00New Information
Sep-27-2020 09:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020
04:07:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-11-2020
21:36:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-11-2020
21:36:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
1Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889274
Page 153 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-28-2020
11:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The response for
item#6,7,8,9,10,11,12,13,and
14 are missing? kindly
review and update.
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-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta 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
Oct-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-22-2020
11:13:56
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
Oct-21-2020
12:10:43
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 1
: Answe
redThe urinary
tract infection
was the cause
of haematuria
which is a
sign of the
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889275
Page 154 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
infection.
Both are part
of the same
illness. Thank
you
Oct-19-2020
18:36:45
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.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 [Urinary
infection].
Any
symptoms,
AEs or other
key data
should be
collected on
the adverse
event page.
Please review
and update as
necessary.
Oct-11-2020
21:36:50
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Mabel Berrueta Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent isInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889276
Page 155 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
due to:
OTH
ER
If
Oth
er,
spe
cify
:
U
ri
n
ar
y
in
fe
ct
io
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-11-2020 21:36:50 ACV0PFEINFP6000 Mabel Berrueta Data Entry: Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889277
Page 156 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos AiresNO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-11-2020 21:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NOInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889278
Page 157 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Jan-20-2021
16:47:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
3: Clo
sedResponse
satisfies query
Jan-19-2021
10:54:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredNew
Information
Jan-19-2021
10:54:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Exace
rbatio
n of gr
oss he
maturiNew
Information
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889279
Page 158 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
a
Jan-11-2021
03:52:35
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
3: Ope
nedThe AE Gross
hematuria was
reported but is
also listed in
Medical
History. Please
clarify if this is
a worsening of
the baseline
condition, and
if so, please
consider adding
"worsening" to
the AE term.
AE as baseline
conditions
should only be
reported as AEs
if they worsen.
Jan-10-2021
10:20:17
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Gross
hemat
uriaNew
Information
Jan-07-2021
11:20:59
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Clo
sedResponse
satisfies query
Jan-07-2021
10:48:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredNew
Information
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889280
Page 159 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-07-2021
10:48:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
High
grade
infiltr
ating
urothe
lial ca
rcino
maNew
Information
Jan-06-2021
12:57:51
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Ope
nedCLINICAL
SAE of Hi
grade
infiltrating
urothelial CA
was reported
(#2021001420);
please enter this
event on the AE
CRF log
Oct-28-2020
20:24:22
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedResponse
satisfies query
Oct-28-2020
10:53:02
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Ans
weredYes, the subject
is being
evaluated by a
urologist for
hematuria.
Thank you
Oct-27-2020
16:04:15
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Ope
nedCLINQUERY:
Is the subject
being evaluated
by a urologist
(cystoscopy)
for hematuria?
Thank you.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889281
Page 160 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-26-2020
09:11:45
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Gross
hemat
uriaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021 10:22:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed moving query to
malignancy SAE
event
Jan-13-2021 02:07:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Please
submit a SAE
safety update
containing the
event Start and
End dates in the
Event reporting
section; currently
SAE contains no
start or end date
Jan-10-2021 10:21:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Jan-10-2021 10:21:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-10-2021 10:21:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/11/2020 08:00New Information
Jan-10-2021 10:20:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For Gross
hematuria: Start
date 02/Jun/2020
is before
V1D1VX1L visit
date 30/Aug/2020.
Please review and
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889282
Page 161 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
update as
appropriate.
Jan-07-2021 17:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For High grade
infiltrating
urothelial
carcinoma: Start
date 02/Jun/2020
is before
V1D1VX1L visit
date 30/Aug/2020.
Please review and
update as
appropriate.
Jan-07-2021 17:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Start date is before
Consent Date
30/Aug/2020.
Jan-07-2021 17:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-07-2021 17:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jun/2/2020 UNK:UNKNew Information
Jan-07-2021 11:26:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical Please
submit a SAE
safety update
containing the
event Start and
End dates in the
Event reporting
section; currently
SAE contains no
start or end date
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/10/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889283
Page 162 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-15-2021 11:19:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/29/2020 17:59New Information
Jan-07-2021 15:41:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/21/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021 17:54:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-15-2021 11:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered It is clarified that
adverse event 2,
gross hematuria, is
considered
non-serious.
Jan-13-2021 10:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL
Hematuria
severity is 1
(therefore no
worsening from
past med hx of
hematuria) and
this grade 1 event
is reported as
Serious. Please
record serious
criteria based on
hematuria even
itself & not on
subsequent cancer
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889284
Page 163 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
diagnosis
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-17-2021 08:05:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Jan-15-2021 11:21:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Jan-15-2021 11:21:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NONew Information
Jan-13-2021 02:09:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-11-2021 09:19:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE RECON: Gross
hematuria(Onset
date:11Oct2020) is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889285
Page 164 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-11-2021 04:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Deleted Query can be
addressed internally
Jan-10-2021 10:20:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE Gross
hematuria: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-07-2021 15:40:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE High grade
infiltrating urothelial
carcinoma: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-07-2021 15:40:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-07-2021 15:40:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
NONew Information
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889286
Page 165 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt serious event
YES
Jan-07-2021 11:22:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL Per SAE
Report #2021001420,
the event Hi Grade
Infiltrating Urothelial
CA is a serious event
on the basis of
Medically
Important/Significant;
however, AE CRF
reports non-SAE.
Please harmonize
reporting, and update
where applicable.
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 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
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889287
Page 166 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021 02:13:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-07-2021 17:50:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered the cause remains
unknown
Jan-06-2021 12:59:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical - 'Other'
cause for event is
reported as
unknown; with
new diagnosis of
high grade
infiltrating
urothelial CA,
please review
'Other' cause and
update as
appropriate
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889288
Page 167 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to
:
OTHER
If Other, specify:
UnknowInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889289
Page 168 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-15-2021 12:19:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-15-2021 12:19:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DNew Information
Jan-15-2021 11:19:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Gross
hematuria:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Jan-07-2021 15:41:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT
RESOLVEDNew Information
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-26-2020 09:11:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889290
Page 169 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-24-2021
13:29:47 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-24-2021
10:26:23 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Mar-24-2021
10:26:23 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
High grade infiltrating urot
helial carcinomaTranscription Error
Mar-24-2021
09:01:27 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Erica Weaver Query 1: Closed Term coded, query
will be closed.
Mar-24-2021
08:09:09 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021001420,the
term was reported as
High grade
infiltrating urothelial
carcinomain Safety
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889291
Page 170 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
database while
updated to Bladder
cancer Stage T1 NX
MX in AE CRF.
Please confirm. If
safety update is
required, please
submit a follow-up
form.
Mar-23-2021
17:45:23 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Erica Weaver Query 1: Opened For coding purposes,
please can you
remove NX MX
abbreviation? Thank
you
Mar-23-2021
15:57:13 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
Bladder cancer Stage T1 N
X MXNew Information
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
High grade infiltrating urot
helial carcinomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 17:53:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies query
Jan-19-2021 07:19:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed onset date updated in
SDB
Jan-17-2021 07:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candid
atepending SDB update
Jan-15-2021 11:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered I clarify that the SAE
start is 29Dec2020
18:00 hs. SAE follow
up was sent.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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)
FDA-CBER-2021-5683-0889292
Page 171 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-15-2021 11:26:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered SAE start is 29Dec2020
18:00 hs. SAE follow
up form was sent.
Jan-13-2021 10:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical Please submit a
SAE safety update
containing the event
Start date. Start date is
29Dec20 (path report);
however, bladder mass
visually confirmed
when biopsied on
04Dec20. Please also
review start date for AE
& SAE.
Jan-13-2021 06:53:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021001420 ,onset
date was blank in Safety
database however,
recorded as 29Dec2020
on AE CRF. Please
confirm correct Onset
Date. If safety update is
required, please submit
a fffup form
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/29/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0889293
Page 172 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
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
Jan-11-2021 04:29:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE High grade
infiltrating
urothelial
carcinoma:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
NOInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0889294
Page 173 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous 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.
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889295
Page 174 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 08:19:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021
06:19:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed sdb updated
Feb-26-2021
04:09:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Reissued:
CandidatePending SDB update
Feb-25-2021
17:09:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered Serious adverse follow-up form is
sent today. I clarify that the status of
the serious adverse event is not
resolved / not recovered.
Feb-24-2021
01:15:54ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021001420,outcome
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (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-2021-5683-0889296
Page 175 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos Aireswas reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Jan-10-2021
10:27:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-10-2021 10:27:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-11-2021 04:29:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2021001420Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889297
Page 176 of 178
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020 09:17:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-30-2020 13:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-30-2020 13:06:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-08-2021 06:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Jan-07-2021 10:57:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered There is no syncope
episode reported as SAE,
on 30DEC2020 an SAE
was reported with the term:
high-grade infiltrating
urothelial carcinoma
Jan-04-2021 08:02:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021001420
syncopal episode(onset
date:0Dec2020)was
reported as 27serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889298
Page 177 of 178
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-12-2020
09:17:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Aug-30-2020
13:08:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
Aug-30-2020
13:06:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889299
Page 178 of 178
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12315404 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 15:02:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f16\Final\Final On: 01-Apr-2021 03:33 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889300