Document text
Page 1 of 133
***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: 12314987 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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886742
Page 2 of 133
***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: 12314987 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/28/2020
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886743
Page 3 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12314987]
2.Birth Date: /1973
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886744
Page 4 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886745
Page 5 of 133
***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: 12314987 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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886746
Page 6 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886747
Page 7 of 133
***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: 12314987 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: Mar/14/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Smoking]
Start Date: Jan/1/1993
Ongoing: YES
1.cLine/MH Number: [3] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity] Comments
Start Date: UNK/UNK/2012 Comments
Ongoing: YES Comments
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886748
Page 8 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [128.0]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [42.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886749
Page 9 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [73181]
3.Randomization Group: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886750
Page 10 of 133
***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: 12314987 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/28/2020
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 [BPWTDC]
5.bSample ID [BPWTDD]
5.cSample ID [BPWTDF]
5.dSample ID [BRXHSL]
5.eSample ID [BRXHSM]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886751
Page 11 of 133
***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: 12314987 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/28/2020
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 [BPT86G]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886752
Page 12 of 133
***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: 12314987 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/28/2020 20:30
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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886753
Page 13 of 133
***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: 12314987 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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886754
Page 14 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886755
Page 15 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886756
Page 16 of 133
***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: 12314987 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:
Sep/16/2020
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 [BP2BDT]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886757
Page 17 of 133
***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: 12314987 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: Sep/16/2020 13:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886758
Page 18 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886759
Page 19 of 133
***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: 12314987 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:
Oct/19/2020
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 [BLBKRP]
5.bSample ID [BLBGZP]
5.cSample ID [BPWDGC]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886760
Page 20 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886761
Page 21 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886762
Page 22 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886763
Page 23 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886764
Page 24 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886765
Page 25 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886766
Page 26 of 133
***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: 12314987 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:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886767
Page 27 of 133
***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: 12314987 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: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886768
Page 28 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886769
Page 29 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886770
Page 30 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886771
Page 31 of 133
***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: 12314987 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:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886772
Page 32 of 133
***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: 12314987 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:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886773
Page 33 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886774
Page 34 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886775
Page 35 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886776
Page 36 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886777
Page 37 of 133
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Dec/6/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886778
Page 38 of 133
***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: 12314987 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:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886779
Page 39 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886780
Page 40 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886781
Page 41 of 133
***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: 12314987 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:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886782
Page 42 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886783
Page 43 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886784
Page 44 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886785
Page 45 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886786
Page 46 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886787
Page 47 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886788
Page 48 of 133
***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: 12314987 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 [ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886789
Page 49 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886790
Page 50 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886791
Page 51 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Non-traumatic cardiorespir
atory arrest Dec/5/2020
21:00 NO
End Date Time:
Dec/6/2020 07:00
Repeating
Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886792
Page 52 of 133
***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: 12314987 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)[Non-traumatic cardiorespiratory arrest]
4.Start Date Time: Dec/5/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/6/2020 07:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
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
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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886793
Page 53 of 133
***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: 12314987 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?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020483431]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886794
Page 54 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886795
Page 55 of 133
***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: 12314987 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[ ]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886796
Page 56 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886797
Page 57 of 133
***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: 12314987 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: //
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886798
Page 58 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886799
Page 59 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886800
Page 60 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886801
Page 61 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886802
Page 62 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886803
Page 63 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886804
Page 64 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886805
Page 65 of 133
***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: 12314987 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?
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886806
Page 66 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886807
Page 67 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886808
Page 68 of 133
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Dec/6/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Non-traumatic cardiorespiratory arrest]
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886809
Page 69 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/6/2020
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886810
Page 70 of 133
***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: 12314987 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
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886811
Page 71 of 133
***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: 12314987 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 Jan-25-2021 18:16:33 (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.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886812
Page 72 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-28-2020 22:25:44 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886813
Page 73 of 133
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1.cDec-17-2020 13:50:46 (UTC-03:00) City of
Buenos AiresAccording to medical records, the date of the
obesity diagnosis is unknown. Thank you.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886814
Page 74 of 133
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1.cDec-17-2020 13:50:46 (UTC-03:00) City of
Buenos AiresAccording to medical records, the date of the
obesity diagnosis is unknown. Thank you.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886815
Page 75 of 133
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1.cDec-17-2020 13:50:46 (UTC-03:00) City of
Buenos AiresAccording to medical records, the date of the
obesity diagnosis is unknown. Thank you.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886816
Page 76 of 133
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1.cDec-17-2020 13:50:46 (UTC-03:00) City of
Buenos AiresAccording to medical records, the date of the
obesity diagnosis is unknown. Thank you.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886817
Page 77 of 133
***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: 12314987 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 Jan-25-2021 18:16:33 (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.
Santiago
Corradetti N/A Jan-24-2021 12:11:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 08:55:14 (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 Dec-07-2020 19:58:58 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (4), (b)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886818
Page 78 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Approved Oct-26-2020 19:58:47 (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.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886819
Page 79 of 133
***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: 12314987 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-28-2020 22:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 22:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886820
Page 80 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 22:25:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/28/2020Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886821
Page 81 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 19:42:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12314987Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 19:41:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 22:25:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 22:25:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 22:25:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886822
Page 82 of 133
***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: 12314987 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-28-2020 22:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/28/2020Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886823
Page 83 of 133
***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: 12314987 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-28-2020 22:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 22:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 22:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886824
Page 84 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 22:26:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Arterial hypert
ension
Start Date: Mar/14/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 22:26:23
(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
Aug-28-2020 22:26:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Arterial hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 22:26:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Mar/14/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 22:26:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886825
Page 85 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.b
Date Location User Value Reason
Aug-28-2020 22:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Smoking
Start Date: Jan/1/199
3
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 22:26:46
(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-28-2020 22:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
SmokingInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 22:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/1/1993Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 22:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.c
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886826
Page 86 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Dec-23-2020 12:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Line/MH Numb
er:3
Medical History
Term:obesity
Start Date: UNK/UNK/
2012
Ongoing: YESInitial Entry
Dec-18-2020 11:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History Ter
m:obesit
y
Start Date:
Ongoing: YESTranscription Error
Dec-17-2020 13:50:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:3
Medical History
Term:obesity
Start Date: UNK/UNK/
1934
Ongoing: YESInitial Entry
Dec-11-2020 12:15:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:obesit
y
Start Date:
Ongoing: YESInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886827
Page 87 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.c Line/MH Number:
Date Location User Value Reason
Dec-11-2020 12:15:03
(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
Dec-11-2020 12:15:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
obesityInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-23-2020 12:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
UNK/UNK/2012Initial Entry
Dec-18-2020 11:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Transcription Error
Dec-18-2020 01:28:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-17-2020 13:50:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1934Initial Entry
Dec-17-2020 13:49:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered According to
medical records on
15DIC2020 The
date of the obesity
diagnosis is
unknown. Thank
you.
Dec-14-2020 03:20:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Please
complete this item.
Thank you.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886828
Page 88 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
1.c Ongoing:
Date Location User Value Reason
Dec-11-2020 12:15:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886829
Page 89 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
128.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886830
Page 90 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
42.3Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Identifier
::1
Temperature: 37.0
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886831
Page 91 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-28-2020 22:27:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886832
Page 92 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 22:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 22:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
73181Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886833
Page 93 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 22:27:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 22:27:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 12:32:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 22:27:40
(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-28-2020 22:27:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 12:32:05
(UTC-03:00) City ofACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPWTDCInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886834
Page 94 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 12:32:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPWTDCInitial Entry
5.b
Date Location User Value Reason
Aug-29-2020 12:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPWTDDInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020 12:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPWTDDInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020 12:32:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BPWTDFInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-29-2020 12:32:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
BPWTDFInitial Entry
5.d
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886835
Page 95 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 15:00:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRXHSLInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-29-2020 15:00:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRXHSLInitial Entry
5.e
Date Location User Value Reason
Aug-29-2020 15:00:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BRXHSMInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-29-2020 15:00:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BRXHSMInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886836
Page 96 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 22:27:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 22:27:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020 12:02:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 22:27:47
(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-28-2020 22:27:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 12:02:02
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BPT86GInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886837
Page 97 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Aug-30-2020 12:02:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT86GInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886838
Page 98 of 133
***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: 12314987 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-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/28/2020 20:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886839
Page 99 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020 22:28:04
(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-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 22:28:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886840
Page 100 of 133
***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: 12314987 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-28-2020 22:28:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886841
Page 101 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020 09:36:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886842
Page 102 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.4
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (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-2021-5683-0886843
Page 103 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020 09:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886844
Page 104 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 16:57:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 16:57:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 16:57:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 16:57:36
(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.
Sep-16-2020 16:57:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 16:57:45
(UTC-03:00) City ofACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP2BDTInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886845
Page 105 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 16:57:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP2BDTInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886846
Page 106 of 133
***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: 12314987 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
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/16/2020 13:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886847
Page 107 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-19-2020 09:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886848
Page 108 of 133
***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: 12314987 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-19-2020 14:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886849
Page 109 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 14:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 14:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 16:05:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 14:23:47
(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-19-2020 14:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 16:05:17
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Sample ID: BLBKRPInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886850
Page 110 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 16:05:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKRPInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 16:19:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BLBGZPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 16:19:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BLBGZPInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 17:10:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWDGCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 17:10:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWDGCInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886851
Page 111 of 133
***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: 12314987 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
Oct-19-2020 14:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 14:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 14:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886852
Page 112 of 133
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314987 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
Dec-11-2020 13:41:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-11-2020 13:41:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Dec-11-2020 13:41:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886853
Page 113 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886854
Page 114 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-07-2020 19:58:58
(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 ValueReason
Mar-04-2021
18:53:10
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
4: Clo
sedResponse satisfies
query
Mar-02-2021
10:40:53
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
4: Ans
weredSeveral attempts
were made to
contact the subject's
son and his brother-
in-law to ask them
to deliver the
subject's autopsy
certificate and
medical history on
the day of his death,
without success. At
the moment there is
no more
information
available
Mar-01-2021
09:40:11ACV0PFEINFP6000 Query
4: OpClinical With
pending data lock,
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886855
Page 115 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of
Buenos Airesenedplease followup on
autopsy result one
additional time
Feb-15-2021
23:51:14
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Clo
sedQuery closed; will
follow for requested
autopsy
information.
Feb-14-2021
18:51:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Ans
weredA new attempt was
made to
communicate with
the participant's
family. Autopsy
results are not
available. If they
are obtained, a new
FUP will be sent.
Thank you.
Feb-10-2021
22:10:47
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Op
enedClinical Followup:
Please submit
autopsy results if
available
Jan-12-2021
23:05:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Clo
sedQuery closed; will
follow for SAE
update with the
requested
AUTOPSY report
info
Dec-28-2020
15:12:09
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Ans
weredIt will be updated
when it is available.
Thank you.
Dec-27-2020
13:15:06
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dCLINICAL Thank
you. Most recent
SAE update
(recorded 24Dec20)
updates event term
to Nontraumatic
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (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-2021-5683-0886856
Page 116 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
cardiac arrest,
which is the death
certificate diagnosis
after autopsy.
However, results of
autopsy are
reported pending;
please update when
available
Dec-26-2020
10:42:37
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Non-t
rauma
tic car
diores
pirato
ry arre
stNew Information
Dec-25-2020
21:14:05
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Ans
weredThis information
was sent on SAE
follow up form on
22DEC
Dec-23-2020
21:13:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dClinical Please
update the fatal
event term when
results of
post-mortem
(autopsy) are
reported; leave
query open until
available
Dec-23-2020
13:50:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredNew Information
Dec-23-2020
13:50:15
(UTC-03:00)ACV0PFEINFP6000 Data
Entry
:New Information
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886857
Page 117 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos AiresNon-t
rauma
tic car
diac a
rrest
Dec-21-2020
21:14:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Clo
sedClosing query until
postmortem
(autopsy) findings
are available.
Dec-21-2020
21:13:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Op
enedClinical Please
update the fatal
event term when
results of
post-mortem
(autopsy) are
reported; leave
query open until
available.
Dec-21-2020
10:54:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: Thank you for
the response,
however the cause
of death is still not
updated as the AE
term with an
outcome of FATAL,
please review and
update, else clarify.
Dec-09-2020
05:09:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Rei
ssued:
Candi
dateDM 1: Per site
response, Please
review cause of
death once CRF
updated. Thank
you.
Dec-08-2020
14:53:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Santiago Corradetti Query
1: Ans
weredAt the moment, the
cause of death is
unknown. CRF will
be updated if we get
any further
information as soon
as possible. Thnak
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886858
Page 118 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
you.
Dec-08-2020
09:17:18
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6394282;This
'Adverse Event'
contains the term
DEATH. If known,
please provide the
cause of death as
the AE term with an
outcome of FATAL
or clarify.
Dec-07-2020
19:58:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Sudde
n Deat
hInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 18:34:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed start date is now in
SAE
Jan-15-2021 12:01:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered The most recent
SAE report was
submitted on
22DEC20. Please
clarify. The start date
was clarified on FU
09DEC20. There
were no subsequent
changes.
Jan-12-2021 23:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened Clinical Thank you.
However most recent
SAE report
(31Dec20) for the
event Nontraumatic
Cardiac Arrest [in
Event section of
SAE] has ?? 2020
for Start Date/Time
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886859
Page 119 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
and no date for Stop
Date/Time. Please
update the Event
section of SAE with
dates.
Dec-28-2020 15:15:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered On 12/22, an event
update form was sent
to the sponsor.
Thank you.
Dec-27-2020 13:17:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened CLINICAL Most
recent SAE update
(24Dec20) states
start date (05Dec) &
death date (06Dec)
in narrative;
however, these dates
are not entered in the
Event section for
Nontraumatic
Cardiac Arrest,
under Onset Date
and Stop Date;
please enter &
submit.
Dec-17-2020 07:26:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-14-2020 03:53:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-12-2020 10:33:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The SAE start date
was Dec 5, 2020 at
9:00 p.m. Thank
you.
Dec-12-2020 10:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Added degree of
toxicity. Thank you
Dec-11-2020 08:22:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2020483431
,onset date was
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886860
Page 120 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
recorded as ---2020
in Safety database
however, recorded as
05Dec2020 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Dec-11-2020 04:24:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thank you for
response. Kindly
provide response to
‘Toxicity Grade’ on
this page.
Dec-10-2020 13:45:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-10-2020 13:45:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/5/2020 21:00New Information
Dec-09-2020 05:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: The response
for Data item#4,5
and 6 are missing.
Kindly review and
update.
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 18:33:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-19-2021 17:56:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered It is clarified that on
Dec 05, 2020 at 9:00
p m., the patient
presented abdominal
discomfort, an
episode of vomiting
and back pain.
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (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-2021-5683-0886861
Page 121 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death certificate:
cause non-traumatic
cardiorespiratory
arrest date and time
of death: 06 Dec
2020 07:00 hs
Jan-18-2021 14:05:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Clinical The most
recent SAE update
on 31Dec20 has the
SAE, without a
START date for the
SAE event (Under
the EVENT tab for
the SAE form).
Please report event
START/END dates.
Jan-15-2021 12:04:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The most recent
SAE report was
submitted on
22DEC20. Please
clarify, what is the
FU on 31DEC?. The
date of death was
clarified on FU
22DEC20.
Jan-12-2021 23:05:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank you.
However most
recent SAE report
(31Dec20) for the
event Nontraumatic
Cardiac Arrest [in
Event section of
SAE] has no date or
time reported for
Stop Date/Time.
Please update the
Event section of
SAE with the Stop
Date/Time date.
Dec-26-2020 10:41:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Information is
updated based on the
death certificate: the
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886862
Page 122 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
cause of death is
non-traumatic
cardiorespiratory
arrest, date and time
of death Dec 6, 2020
07:00 am. Event
update form sent to
sponsor. Thank you.
Dec-23-2020 21:15:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened CLINICAL Thank
you. However the
SAE section for the
Event Section for
SAE Non-traumatic
Cardiac Arrest does
not have an entry for
either Onset date or
Stop date; please
send a SAE
followup with this
information in the
event section.
Dec-23-2020 13:50:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/6/2020 07:00New Information
Dec-23-2020 13:49:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered SAE follow up form
was sent with this
information
Dec-21-2020 21:15:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical - SAE end
date is reported as
06Dec20; however,
SAE report has no
end date. Please
review, harmonize
reporting, and
update in the
applicable location
Dec-10-2020 13:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (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-2021-5683-0886863
Page 123 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Dec/6/2020 04:00
6. Toxicity Grade:
Date Location User Value Reason
Dec-12-2020 10:32:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-09-2020 06:59:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886864
Page 124 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Sudden
Death: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0886865
Page 125 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
NO
Other medically important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-07-2020 19:58:58 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0886866
Page 126 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos AiresNO
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-07-2020 19:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Dec-14-2020
10:14:40
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Dec-11-2020
13:42:23
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: An
swere
dDisposition form at
FUP was
completed. Thank
you.
Dec-11-2020
02:28:50
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dDisposition form at
FUP visit is still
blank. Please
complete as
required. Or
clarify.
Dec-11-2020
02:12:37
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Dec-10-2020
14:05:56
(UTC-03:00)ACV0PFEINFP6000 Query
2: An
swereThe CRF was
updated
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0886867
Page 127 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos
Airesd
Dec-10-2020
14:04:21
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dAnswer Auto
Query
Dec-09-2020
01:30:20
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW6394298;The
outcome of this AE
is selected as
FATAL, but there
are no Disposition
eCRFs with a
'Status' of DEATH.
Please review and
update as
appropriate.
Dec-08-2020
07:31:37
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM1: Per
response, kindly
update the details
once available on
the 'Date of
Collection /
Notification of
Death on the Death
Details form' and
later update the
query status to
Answered. Thank
you.
Dec-07-2020
20:01:04
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: An
swere
dAt the moment,
date and time of
death are unknown,
and no further
information is
available.
Dec-07-2020
19:58:58
(UTC-03:00)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedResponse to "What
was the outcome of
this adverse
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886868
Page 128 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos
Airesevent?" is 'Fatal'
but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
Dec-07-2020
19:58:58
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
FATA
LInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-11-2021 05:24:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Closing as data is
updated
Jan-08-2021 15:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-08-2021 15:37:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YESTranscription Error
Jan-08-2021 10:18:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Outcome is
reported as ‘Fatal’;
however, "Did the
event cause the
subject to be
discontinued from
the study" is not
YES. Please review
and update the CRF
Appropriately.
Dec-07-2020 19:58:58
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886869
Page 129 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-09-2020 06:59:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020483431Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886870
Page 130 of 133
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-25-2021 08:05:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-24-2021 12:11:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 1: Answered Changed data per
query
Jan-24-2021 00:28:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Please report
cause of death.
Dec-10-2020 14:04:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/6/2020Initial Entry
2.a
Date Location User Value Reason
Jan-24-2021 12:11:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Cause of D
eath Status
:PRIMARY CAU
SE OF DEATH
Cause of D
eath:Non-traumatic car
diorespiratory arr
estInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Jan-24-2021 12:11:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
PRIMARY CAUSE OF DEAT
HInitial Entry
2.a Cause of Death:
Date Location User Value Reason
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886871
Page 131 of 133
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-24-2021 12:11:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Non-traumatic cardiorespirator
y arrestInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886872
Page 132 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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1. Subject Status
Date Location User Value Reason
Dec-11-2020 13:41:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-19-2020 14:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 22:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 22:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-11-2020 13:41:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/6/2020Initial Entry
Oct-19-2020 14:24:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-28-2020 22:27:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 22:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886873
Page 133 of 133
***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: 12314987 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 19:58:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ec7\Final\Final On: 01-Apr-2021 03:22 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886874