Document text
Page 1 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871989
Page 2 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871990
Page 3 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12312982]
2.Birth Date: /1984
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0871991
Page 4 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871992
Page 5 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon
study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination,
and clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with
the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871993
Page 6 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871994
Page 7 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871995
Page 8 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871996
Page 9 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871997
Page 10 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [83.5]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [25.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871998
Page 11 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [61389]
3.Randomization Group: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0871999
Page 12 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHY61W]
5.bSample ID [BHY61X]
5.cSample ID [BHY61Y]
5.dSample ID [BJ4998]
5.eSample ID [BJ4999]
5 fSample ID [BJ4997]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872000
Page 13 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHY64K]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872001
Page 14 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 18:50
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
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872002
Page 15 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872003
Page 16 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872004
Page 17 of 349
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872005
Page 18 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1YWS]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872006
Page 19 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/9/2020 14:00
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
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872007
Page 20 of 349
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872008
Page 21 of 349
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872009
Page 22 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872010
Page 23 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872011
Page 24 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872012
Page 25 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872013
Page 26 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872014
Page 27 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872015
Page 28 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872016
Page 29 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/12/2020
2.Date of First Symptom Started: Sep/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/12/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872017
Page 30 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [nausea]
5.cSymptoms - Other Text: [dark urine]
5.dSymptoms - Other Text: [dizziness]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872018
Page 31 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/12/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872019
Page 32 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/12/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872020
Page 33 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872021
Page 34 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Not applicable]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872022
Page 35 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872023
Page 36 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Sep/12/2020 NO
Discharge Date:
Sep/13/2020
Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872024
Page 37 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/12/2020
4.Ongoing? NO
Discharge Date:
Sep/13/2020
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872025
Page 38 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872026
Page 39 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872027
Page 40 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872028
Page 41 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872029
Page 42 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872030
Page 43 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.CLINICAL
CHEMISTR
Y Hospital Aleman, Av. Pueyrredon
1640, C1118 AAT, Buenos Aires,
Argentina Sep/12/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Resu
lt:
Unknown Unknown Unk
now
n
Unknown Alanine Amino
transferase_PX
30 Unk
now
n
Unknown Aspartate Amin
otransferase_P
X28 Unk
now
n
Unknown Alkaline Phosp
hatase_PX35 Unk
now
n
Unknown Bilirubin_PX2
1 Unk
now
n
Unknown Blood Urea Nit
rogen_PX47 Unk
now
n
48 Creatinine_PX
48 1.21 Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872031
Page 44 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Hospital Aleman, Av. Pueyrredon 1640, C1118 AAT, Buenos Aires, Argentina]
3.Collection Date: Sep/12/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: Unknown
[ ]Comments
Test: C Reactive Protein_PX329
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872032
Page 45 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.bSponsor ID: Unknown
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Unknown
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872033
Page 46 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.dSponsor ID: Unknown
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Unknown
[ ]Comments
Test: Bilirubin_PX21
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872034
Page 47 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5 fSponsor ID: Unknown
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.21]
Not Done:
LNMT Low
[0.7]
High
[1.3]
Unit
mg/dL
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872035
Page 48 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.HEMATOL
OGY Hospital Aleman, Av. Pueyrredon 16
40, C1118 AAT, Buenos Aires, Arge
ntina Sep/12/2
020 BLOO
D Sponsor-Def
ined Identifi
erTest:Resu
lt:
Unknown Hemoglobi
n_PX1 Unkn
own
Unknown Hematocrit
_PX2 Unkn
own
Unknown Erythrocyt
es_PX3 Unkn
own
Unknown Platelets_P
X5 Unkn
own
Unknown Leukocyte
s_PX7 Unkn
own
Unknown Neutrophil
s_PX608 Unkn
own
Unknown Eosinophil
s_PX609 Unkn
own
Unknown Monocytes
_PX612 Unkn
own
Unknown Basophils_
PX610 Unkn
own
Unknown Lymphocy
tes_PX611
Unkn
own Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872036
Page 49 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Hospital Aleman, Av. Pueyrredon 1640, C1118 AAT, Buenos Aires, Argentina]
3.Collection Date: Sep/12/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: Unknown
[ ]Comments
Test: Hemoglobin_PX1
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872037
Page 50 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.bSponsor ID: Unknown
[ ]Comments
Test: Hematocrit_PX2
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Unknown
[ ]Comments
Test: Erythrocytes_PX3
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872038
Page 51 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.dSponsor ID: Unknown
[ ]Comments
Test: Platelets_PX5
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Unknown
[ ]Comments
Test: Leukocytes_PX7
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872039
Page 52 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5 fSponsor ID: Unknown
[ ]Comments
Test: Neutrophils_PX608
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Unknown
[ ]Comments
Test: Eosinophils_PX609
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872040
Page 53 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.hSponsor ID: Unknown
[ ]Comments
Test: Monocytes_PX612
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Unknown
[ ]Comments
Test: Basophils_PX610
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872041
Page 54 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.jSponsor ID: Unknown
[ ]Comments
Test: Lymphocytes_PX611
Result: Unknown
[ ]Comments
Not Done: Unknown Comments
LNMT Unknown
Low
[ ]
High
[ ]
UnitComments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872042
Page 55 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872043
Page 56 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872044
Page 57 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872045
Page 58 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872046
Page 59 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872047
Page 60 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: OXYGENATION PARAMETERS
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872048
Page 61 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872049
Page 62 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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.Start Date: //
6.Ongoing?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872050
Page 63 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Sep/12/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
right lung consolidation
Repeating Pages
2.Sep/12/2020 CHEST CT SCAN NORMAL Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872051
Page 64 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/12/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[right lung consolidation]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872052
Page 65 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/12/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872053
Page 66 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872054
Page 67 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872055
Page 68 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872056
Page 69 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872057
Page 70 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [The subject reports that the decision to stop participating in the study is of a personal
nature]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872058
Page 71 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Sep/23/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Withdrawal of consent for personal reasons]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872059
Page 72 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872060
Page 73 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872061
Page 74 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872062
Page 75 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872063
Page 76 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872064
Page 77 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872065
Page 78 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872066
Page 79 of 349
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872067
Page 80 of 349
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872068
Page 81 of 349
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872069
Page 82 of 349
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872070
Page 83 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872071
Page 84 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872072
Page 85 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Suspected COVID-19 Il
lness Sep/9/2020 21:0
0 NO
End Date Time:
Sep/14/2020 11:00
Repeating
Pages
2.ADVERSE EVE
NT 2 mild pain at the injectio
n site Aug/23/2020 11
:17 NO
End Date Time:
Aug/25/2020 14:47
Repeating
Pages
3.ADVERSE EVE
NT 3 severe anxiety Sep/23/2020 23:
00 NO
End Date Time:
Oct/14/2020 15:30
Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872073
Page 86 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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)[Suspected COVID-19 Illness]
4.Start Date Time: Sep/9/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/14/2020 11:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872074
Page 87 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020354694]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872075
Page 88 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[mild pain at the injection site]
4.Start Date Time: Aug/23/2020 11:17
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 14:47
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872076
Page 89 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872077
Page 90 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[severe anxiety]
4.Start Date Time: Sep/23/2020 23:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/14/2020 15:30
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[constitutive features]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872078
Page 91 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
11.Was a Concomitant Medication
given?NO Comments
12.Was a Non-Drug Treatment given? NO Comments
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872079
Page 92 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872080
Page 93 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872081
Page 94 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872082
Page 95 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: //
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872083
Page 96 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872084
Page 97 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872085
Page 98 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872086
Page 99 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872087
Page 100 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872088
Page 101 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872089
Page 102 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872090
Page 103 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872091
Page 104 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872092
Page 105 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/23/2020
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872093
Page 106 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872094
Page 107 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/23/2020
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872095
Page 108 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872096
Page 109 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 00:37:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872097
Page 110 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormAug-22-2020 09:27:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872098
Page 111 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:34:06 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872099
Page 112 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:34:06 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872100
Page 113 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:34:06 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872101
Page 114 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:34:06 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872102
Page 115 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:34:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872103
Page 116 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:34:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872104
Page 117 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:34:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872105
Page 118 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:34:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872106
Page 119 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:34:52 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872107
Page 120 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:34:52 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872108
Page 121 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:34:52 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872109
Page 122 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:34:52 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872110
Page 123 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:35:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872111
Page 124 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:35:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872112
Page 125 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:35:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872113
Page 126 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:35:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872114
Page 127 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:35:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872115
Page 128 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:35:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872116
Page 129 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:35:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872117
Page 130 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:35:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872118
Page 131 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:35:47 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872119
Page 132 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:35:47 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872120
Page 133 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:35:47 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872121
Page 134 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:35:47 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872122
Page 135 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:55:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872123
Page 136 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:55:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872124
Page 137 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:55:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872125
Page 138 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.aOct-29-2020 15:55:24 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872126
Page 139 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:55:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872127
Page 140 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:55:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872128
Page 141 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:55:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872129
Page 142 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.bOct-29-2020 15:55:34 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872130
Page 143 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:56:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872131
Page 144 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:56:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872132
Page 145 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:56:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872133
Page 146 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.cOct-29-2020 15:56:19 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872134
Page 147 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:56:32 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872135
Page 148 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:56:32 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872136
Page 149 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:56:32 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872137
Page 150 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.dOct-29-2020 15:56:32 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872138
Page 151 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:56:42 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872139
Page 152 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:56:42 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872140
Page 153 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:56:42 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872141
Page 154 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.eOct-29-2020 15:56:42 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872142
Page 155 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:56:57 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872143
Page 156 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:56:57 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872144
Page 157 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:56:57 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872145
Page 158 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.fOct-29-2020 15:56:57 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872146
Page 159 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.gOct-29-2020 15:57:09 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872147
Page 160 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.gOct-29-2020 15:57:09 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872148
Page 161 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.gOct-29-2020 15:57:09 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872149
Page 162 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.gOct-29-2020 15:57:09 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872150
Page 163 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.hOct-29-2020 15:57:35 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872151
Page 164 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.hOct-29-2020 15:57:35 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872152
Page 165 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.hOct-29-2020 15:57:35 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872153
Page 166 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.hOct-29-2020 15:57:35 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872154
Page 167 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.iOct-29-2020 15:57:46 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872155
Page 168 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.iOct-29-2020 15:57:46 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872156
Page 169 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.iOct-29-2020 15:57:46 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872157
Page 170 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.iOct-29-2020 15:57:46 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872158
Page 171 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.jOct-29-2020 15:58:03 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872159
Page 172 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.jOct-29-2020 15:58:03 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872160
Page 173 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.jOct-29-2020 15:58:03 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872161
Page 174 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
5.jOct-29-2020 15:58:03 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872162
Page 175 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
11Oct-29-2020 16:45:52 (UTC-03:00) City of Buenos
Aires
11Oct-08-2020 21:01:10 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0872163
Page 176 of 349
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
12Oct-29-2020 15:52:45 (UTC-03:00) City of Buenos
AiresAdolfo Gonzalez
12Oct-08-2020 21:07:21 (UTC-03:00) City of Buenos
AiresUnknown
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872164
Page 177 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormMar-01-2021 14:45:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0872165
Page 178 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
1Mar-01-2021 14:45:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0872166
Page 179 of 349
***Confidential***
Header Text: C4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
2Mar-01-2021 14:45:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0872167
Page 180 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 00:37:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-01-2021 14:44:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-25-2020 17:34:51 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-19-2020 15:35:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Nov-17-2020 08:26:57 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872168
Page 181 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 19:01:55 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Nov-16-2020 11:18:59 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 10:31:04 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-14-2020 12:11:23 (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.
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872169
Page 182 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
N/A Nov-12-2020 09:28:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-10-2020 18:04:54 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-10-2020 09:02:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-04-2020 16:52:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872170
Page 183 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-22-2020 09:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-22-2020 09:26:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872171
Page 184 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-22-2020 09:26:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/21/2020Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872172
Page 185 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-21-2020 17:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12312982Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 17:39:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-22-2020 09:27:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-22-2020 09:27:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-22-2020 09:27:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872173
Page 186 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 09:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Data updated
Aug-28-2020 04:08:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candidate Data updated
Aug-27-2020 11:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Electronic Sample
Tracking Nasal Swab
was collected and
form was completed.
Aug-25-2020 07:49:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM Query: Please
review and consider
to complete
“Electronic Sample
Tracking-Nasal
Swab” form. Thank
you.
Aug-22-2020 09:27:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872174
Page 187 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and 8
5 years, inclusive, or 18 and
85 years, inclusive, at rando
mization (dependent upon st
udy stage)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusive
, 65 and 85 years, inclusive, or 18 an
d 85 years, inclusive, at randomizatio
n (dependent upon study stage)Initial Entry
1.a Criterion met?
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872175
Page 188 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with a
ll scheduled visits, vaccinat
ion plan, laboratory tests, li
festyle considerations, and
other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872176
Page 189 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Inclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study p
roceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical his
tory, physical examination,
and clinical judgment of the
investigator to be eligible fo
r inclusion in the studyInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872177
Page 190 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclus
ion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872178
Page 191 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance w
ith the requirements and res
trictions listed in the ICD a
nd in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN04A00Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872179
Page 192 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed inf
ormed consent, which includes comp
liance with the requirements and rest
rictions listed in the ICD and in this p
rotocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatri
c condition incl. recent (wit
hin past year) or active suici
dal ideation/behavior/lab ab
normality that may increase
the risk of study participatio
nInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872180
Page 193 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or act
ive suicidal ideation/behavior/lab abn
ormality that may increase the risk of
study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872181
Page 194 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency vi
rus (HIV), hepatitis C vir
us (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872182
Page 195 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a va
ccine and/or severe allergic
reaction (eg, anaphylaxis) t
o any component of the stu
dy intervention(s)Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872183
Page 196 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction as
sociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-22-2020 09:27:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872184
Page 197 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresExclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclusi8Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872185
Page 198 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires on Nu
mber:
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or susp
ected immunodeficiency, a
s determined by history an
d/or laboratory/physical ex
amination
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872186
Page 199 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficie
ncy, as determined by history and/or
laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or condi
tion associated with prolon
ged bleeding that would, in
the opinion of the investiga
tor, contraindicate intramus
cular injectionInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872187
Page 200 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that w
ould, in the opinion of the investigato
r, contraindicate intramuscular injecti
onInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-22-2020 09:27:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872188
Page 201 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresExclusion Num
ber:11
Criterion Descr
iption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872189
Page 202 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion Des
cription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872190
Page 203 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agents
or systemic corticosteroi
ds
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppre
ssive therapy, such as cytotoxic agent
s or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872191
Page 204 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Desc
ription:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study i
ntervention administration
or planned receipt througho
ut the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX14A01Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872192
Page 205 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befor
e study intervention administration or
planned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872193
Page 206 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days prio
r to study entry and/or dur
ing study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872194
Page 207 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contai
ning lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872195
Page 208 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studie
s involving study intervention contai
ning lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872196
Page 209 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise sup
ervised by the investigator,
and their respective family
members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0872197
Page 210 of 349
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise supe
rvised by the investigator, and their r
espective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 09:27:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872198
Page 211 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-22-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-22-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-22-2020 09:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872199
Page 212 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
83.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
182.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.2Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872200
Page 213 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7.a
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-22-2020 09:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872201
Page 214 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-22-2020 09:28:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-22-2020 09:28:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
61389Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872202
Page 215 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020 18:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020 18:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-23-2020 18:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-23-2020 18:53:22
(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-23-2020 18:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-23-2020 18:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY61WInitial Entry
5.a Sample ID
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872203
Page 216 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-23-2020 18:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY61WInitial Entry
5.b
Date Location User Value Reason
Aug-23-2020 18:54:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY61XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-23-2020 18:54:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY61XInitial Entry
5.c
Date Location User Value Reason
Aug-23-2020 18:55:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY61YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-23-2020 18:55:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY61YInitial Entry
5.d
Date Location User Value Reason
Sep-04-2020 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4998Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872204
Page 217 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.d Sample ID
Date Location User Value Reason
Sep-04-2020 18:45:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4998Initial Entry
5.e
Date Location User Value Reason
Sep-04-2020 18:45:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4999Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-04-2020 18:45:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4999Initial Entry
5.f
Date Location User Value Reason
Sep-25-2020 12:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ4997Initial Entry
5.f Sample ID
Date Location User Value Reason
Sep-25-2020 12:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ4997Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (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-2021-5683-0872205
Page 218 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 13:54:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 13:54:17
(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-25-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 13:54:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY64KInitial Entry
5.a Sample ID
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872206
Page 219 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-25-2020 13:54:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY64KInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872207
Page 220 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/21/2020 18:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872208
Page 221 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7. Route:
Date Location User Value Reason
Aug-22-2020 09:28:36
(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-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-22-2020 09:28:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872209
Page 222 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-22-2020 09:28:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872210
Page 223 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 01:25:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Sep-22-2020 11:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered SAE was a febrile
syndrome secondary
to severe
reactogenicity related
to the investigational
product. Thank you.
Sep-14-2020 11:30:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Per PA-5 -
Sections 8.3.7. and
8.13., please
COVID-19 related
event PNEUMONIA
reported as a SAE to
Safety should trigger
a COVID Illness Visit
regardless of other
potential diagnosis
and a NASAL SWAB
needs to be collected
ASAP.
Sep-09-2020 17:07:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/9/2020Initial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872211
Page 224 of 349
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872212
Page 225 of 349
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-09-2020 17:07:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872213
Page 226 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 10:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 02:13:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-09-2020 17:08:04
(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-09-2020 17:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872214
Page 227 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-10-2020 10:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1YWSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 10:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1YWSInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872215
Page 228 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/9/2020 14:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872216
Page 229 of 349
***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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
7. Route:
Date Location User Value Reason
Sep-09-2020 17:08:20
(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-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-09-2020 17:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0872217
Page 230 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020 04:07:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Oct-30-2020 09:52:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered The subject needed
hospitalization and
the sample was taken
on September 12, by
his private medicine
service. No more data
is available. No home
visit was made by
protocol.Thanks you
Oct-30-2020 07:55:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Oct-28-2020 11:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Oct-27-2020 12:33:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 12:20:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-27-2020 12:17:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872218
Page 231 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Oct-27-2020 12:17:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Oct-27-2020 12:17:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-27-2020 12:17:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e71\Final\Final On: 01-Apr-2021 03:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0872219
Page 232 of 349
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312982 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-27-2020 12:20:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-27-2020 12:20:
…[truncated]