Document text
Page 1 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860566
Page 2 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/15/2020
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860567
Page 3 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311352]
2.Birth Date: 1974
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860568
Page 4 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860569
Page 5 of 588
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860570
Page 6 of 588
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion ID: (For Pfizer use only) EX01A00
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860571
Page 7 of 588
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860572
Page 8 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860573
Page 9 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2003
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic gastritis]
Start Date: UNK/UNK/2003
Ongoing: YES
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860574
Page 10 of 588
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [86.25]
3.Unit: kg
4.Height: [161.0]
5.Unit: cm
6.Body Mass Index: [33.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860575
Page 11 of 588
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860576
Page 12 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [51324]
3.Randomization Group: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860577
Page 13 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
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 [BLCVT7]
5.bSample ID [BLCV91]
5.cSample ID [BM8412]
5.dSample ID [BM8411]
5.eSample ID [BM8410]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860578
Page 14 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
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 [BM83TV]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860579
Page 15 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/15/2020 14:55
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860580
Page 16 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860581
Page 17 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860582
Page 18 of 588
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/23/2020
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/22/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/22/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860583
Page 19 of 588
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860584
Page 20 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860585
Page 21 of 588
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860586
Page 22 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP27BW]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860587
Page 23 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/4/2020 16:20
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860588
Page 24 of 588
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860589
Page 25 of 588
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860590
Page 26 of 588
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860591
Page 27 of 588
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BLBY0V]
5.bSample ID [BLBY0D]
5.cSample ID [BPXHHT]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860592
Page 28 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860593
Page 29 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/22/2020
2.Date of First Symptom Started: Aug/20/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860594
Page 30 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860595
Page 31 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Aug/22/20
20 Unknown Unknown SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Sep/1/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860596
Page 32 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Aug/22/2020
2.Specimen Type: Unknown Comments
3.Specimen Collection Location: Unknown Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860597
Page 33 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/1/2020
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: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860598
Page 34 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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:[the subject is hospitalized.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860599
Page 35 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[the subject is hospitalized.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2738]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860600
Page 36 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860601
Page 37 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Aug/21/2020 NO
Discharge Date:
Aug/22/2020
Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860602
Page 38 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Aug/21/2020
4.Ongoing? NO
Discharge Date:
Aug/22/2020
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860603
Page 39 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860604
Page 40 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860605
Page 41 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?YES
Respiratory Illness Diagnosis:
[Flu syndrome]
Date of Diagnosis:
Aug/22/2020
3.Toxicity Grade: 3
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860606
Page 42 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860607
Page 43 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860608
Page 44 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860609
Page 45 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860610
Page 46 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860611
Page 47 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860612
Page 48 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860613
Page 49 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860614
Page 50 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860615
Page 51 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860616
Page 52 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860617
Page 53 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860618
Page 54 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860619
Page 55 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860620
Page 56 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Aug/21/2020 CHEST X-RAY NORMAL Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860621
Page 57 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Aug/21/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860622
Page 58 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860623
Page 59 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/13/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860624
Page 60 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [NASAL CONGESTION]
5.cSymptoms - Other Text: [fatigue]
5.dSymptoms - Other Text: [yellowish expectoration]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860625
Page 61 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/9/2020
SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
2.Nov/3/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860626
Page 62 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/9/2020
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: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860627
Page 63 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/3/2020
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: [unknown]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860628
Page 64 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860629
Page 65 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/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 [BPXJTV]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860630
Page 66 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860631
Page 67 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1. DELETED Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860632
Page 68 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860633
Page 69 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860634
Page 70 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860635
Page 71 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860636
Page 72 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860637
Page 73 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860638
Page 74 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860639
Page 75 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860640
Page 76 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860641
Page 77 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860642
Page 78 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860643
Page 79 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860644
Page 80 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860645
Page 81 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860646
Page 82 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860647
Page 83 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860648
Page 84 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860649
Page 85 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860650
Page 86 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860651
Page 87 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: IMAGING
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860652
Page 88 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860653
Page 89 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/18/2020
2.Date of First Symptom Started: Nov/12/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/24/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860654
Page 90 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptoms - Other
5.aSymptoms - Other Text: [nasal congestion]
5.bSymptoms - Other Text: [headache]
5.cSymptoms - Other Text: [asthenia]
5.dSymptoms - Other Text: [rhinitis]
5.eSymptoms - Other Text: [right chest pain]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860655
Page 91 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/18/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860656
Page 92 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/18/2020
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: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860657
Page 93 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860658
Page 94 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
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 [BPW858]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860659
Page 95 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860660
Page 96 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860661
Page 97 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860662
Page 98 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860663
Page 99 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860664
Page 100 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860665
Page 101 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860666
Page 102 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860667
Page 103 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY Hospital General de Agudos Jose Maria
Ramos Mejia. Address: General Urquiza
609. Ciudad de Buenos Aires Nov/2
7/2020
BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive P
rotein_PX32
9 [ ]
30 Alanine Ami
notransferase
_PX30 12
28 Aspartate A
minotransfer
ase_PX28 [ ]
35 Alkaline Pho
sphatase_PX
35 86
21 Bilirubin_PX
21 0.3
7
47 Blood Urea
Nitrogen_PX
47 [ ]
48 Creatinine_P
X48 [ ] Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860668
Page 104 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Hospital General de Agudos Jose Maria Ramos Mejia. Address: General Urquiza
609. Ciudad de Buenos Aires]
3.Collection Date: Nov/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [12] Comments
Not Done: Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860669
Page 105 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [86]
Not Done:
LNMT Low
[35]
High
[105]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.37]
Not Done:
LNMT Low
[0.00]
High
[1.20]
Unit
mg/dL
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860670
Page 106 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860671
Page 107 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
1.HEMATO
LOGY Hospital General de Agudos Jose Maria Ra
mos Mejia. Address: General Urquiza 609.
Ciudad de Buenos Aires Nov/27
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
1 Hemoglo
bin_PX1 12.
50
2 Hematoc
rit_PX2 38.
0
3 Erythroc
ytes_PX3
4.5
2
5 Platelets_
PX5 292
.0
7 Leukocyt
es_PX7 7.8
5
608 Neutroph
ils_PX60
8 52.
7
609 Eosinoph
ils_PX60
9 0.0
8
612 Monocyt
es_PX61
2 7.3
610 Basophil
s_PX610
0.0
3
611 Lymphoc
ytes_PX6
11 3.0
0 Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860672
Page 108 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Hospital General de Agudos Jose Maria Ramos Mejia. Address: General Urquiza
609. Ciudad de Buenos Aires]
3.Collection Date: Nov/27/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.50]
Not Done:
LNMT Low
[11.20]
High
[15.70]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38.0]
Not Done:
LNMT Low
[34.1]
High
[44.9]
Unit
%
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860673
Page 109 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.52]
Not Done:
LNMT Low
[3.93]
High
[5.22]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [292.0]
Not Done:
LNMT Low
[182.0]
High
[369.0]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [7.85]
Not Done:
LNMT Low
[3.98]
High
[10.04]
Unit
10^9/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860674
Page 110 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [52.7]
Not Done:
LNMT Low
[34]
High
[71.1]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.08]
Not Done:
LNMT Low
[0.7]
High
[5.8]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [7.3]
Not Done:
LNMT Low
[4.7]
High
[12.5]
Unit
10^9/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860675
Page 111 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.03]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [3.00]
Not Done:
LNMT Low
[19.3]
High
[51.7]
Unit
10^9/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860676
Page 112 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Date: Vital Signs Details Form Instance
1.Nov/18/2020 Record Identifier: Systolic: Diastolic:
1 120 80 Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860677
Page 113 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [80]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [140]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860678
Page 114 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860679
Page 115 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860680
Page 116 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860681
Page 117 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860682
Page 118 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860683
Page 119 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860684
Page 120 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860685
Page 121 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: IMAGING
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860686
Page 122 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860687
Page 123 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/16/2021
2.Date of First Symptom Started: Jan/14/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/19/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860688
Page 124 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Asthenia]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860689
Page 125 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/16/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860690
Page 126 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/16/2021
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: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860691
Page 127 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860692
Page 128 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/16/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTC2G]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860693
Page 129 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860694
Page 130 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860695
Page 131 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860696
Page 132 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860697
Page 133 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860698
Page 134 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: 1
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860699
Page 135 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860700
Page 136 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860701
Page 137 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860702
Page 138 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860703
Page 139 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860704
Page 140 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860705
Page 141 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860706
Page 142 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860707
Page 143 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860708
Page 144 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860709
Page 145 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860710
Page 146 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860711
Page 147 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860712
Page 148 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860713
Page 149 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860714
Page 150 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: IMAGING
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860715
Page 151 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Sep/21/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860716
Page 152 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Sep/21/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BRVNP7]
5.bSample ID [BPW9L0]
5.cSample ID [BRVNP8]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860717
Page 153 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860718
Page 154 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/29/2020
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 [BRVNLW]
5.bSample ID [BRVNN8]
5.cSample ID [BPTBR0]
5.dSample ID [BRVNN9]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860719
Page 155 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Feb/13/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D1
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860720
Page 156 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 3 - Unscheduled
Visit on Feb/13/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/13/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM8ND]
5.bSample ID [BRYP8G]
5.cSample ID [BS1V8F]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860721
Page 157 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860722
Page 158 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860723
Page 159 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860724
Page 160 of 588
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860725
Page 161 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860726
Page 162 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860727
Page 163 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860728
Page 164 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860729
Page 165 of 588
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860730
Page 166 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860731
Page 167 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860732
Page 168 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860733
Page 169 of 588
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/13/2021
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860734
Page 170 of 588
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/13/2021
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860735
Page 171 of 588
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected in the convalescence visit today.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860736
Page 172 of 588
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/13/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM8N3]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860737
Page 173 of 588
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860738
Page 174 of 588
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMCRV]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860739
Page 175 of 588
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/08/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860740
Page 176 of 588
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR22BH]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860741
Page 177 of 588
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860742
Page 178 of 588
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860743
Page 179 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860744
Page 180 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/10/2021
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860745
Page 181 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860746
Page 182 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860747
Page 183 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/10/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860748
Page 184 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYXFR]
5.bSample ID [BR1P1S]
5.cSample ID [BRYF2S]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860749
Page 185 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1PMP]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860750
Page 186 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/10/2021 12:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860751
Page 187 of 588
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860752
Page 188 of 588
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860753
Page 189 of 588
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860754
Page 190 of 588
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860755
Page 191 of 588
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860756
Page 192 of 588
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860757
Page 193 of 588
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860758
Page 194 of 588
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860759
Page 195 of 588
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860760
Page 196 of 588
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860761
Page 197 of 588
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860762
Page 198 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Flu like syndrome Aug/20/2020 20:
00 NO
End Date Time:
Aug/28/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Vomiting Aug/29/2020 08:
30 NO
End Date Time:
Sep/1/2020 23:00
Repeating
Pages
3.ADVERSE EVE
NT 3 high urinary infect
ion Aug/20/2020 10:
00 NO
End Date Time:
Oct/29/2020 08:00
Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860763
Page 199 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Flu like syndrome]
4.Start Date Time: Aug/20/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 UNK:UNK
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
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860764
Page 200 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[2020327610]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860765
Page 201 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Vomiting]
4.Start Date Time: Aug/29/2020 08:30
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 23:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860766
Page 202 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860767
Page 203 of 588
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[high urinary infection]
4.Start Date Time: Aug/20/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860768
Page 204 of 588
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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[ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860769
Page 205 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860770
Page 206 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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[ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860771
Page 207 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860772
Page 208 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: //
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860773
Page 209 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860774
Page 210 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860775
Page 211 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860776
Page 212 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860777
Page 213 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860778
Page 214 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860779
Page 215 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860780
Page 216 of 588
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860781
Page 217 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860782
Page 218 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860783
Page 219 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860784
Page 220 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860785
Page 221 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-24-2020 08:59:00 (UTC-03:00) City of
Buenos Aires
FormAug-15-2020 19:41:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860786
Page 222 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Aug-31-2020 14:45:10 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860787
Page 223 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Aug-31-2020 14:47:49 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860788
Page 224 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Nov-04-2020 08:40:07 (UTC-03:00) City of
Buenos Aires
6Aug-31-2020 14:48:31 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860789
Page 225 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormOct-29-2020 14:51:44 (UTC-03:00) City of
Buenos AiresNot applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860790
Page 226 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormOct-30-2020 17:50:36 (UTC-03:00) City of
Buenos Airesnot applicable
Not Applicable
FormOct-30-2020 16:00:41 (UTC-03:00) City of
Buenos AiresTatiana Estrada not applicable
FormOct-30-2020 12:01:06 (UTC-03:00) City of
Buenos AiresChange information
FormOct-30-2020 11:08:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860791
Page 227 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Oct-30-2020 17:50:36 (UTC-03:00) City of
Buenos Airesnot applicable
Not Applicable
1Oct-30-2020 12:01:06 (UTC-03:00) City of
Buenos AiresChange information
1Oct-30-2020 11:08:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860792
Page 228 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Oct-30-2020 17:50:36 (UTC-03:00) City of
Buenos Airesnot applicable
Not Applicable
2Oct-30-2020 12:01:06 (UTC-03:00) City of
Buenos AiresChange information
2Oct-30-2020 11:08:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860793
Page 229 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Oct-30-2020 17:50:36 (UTC-03:00) City of
Buenos Airesnot applicable
Not Applicable
3Oct-30-2020 12:01:06 (UTC-03:00) City of
Buenos AiresChange information
3Oct-30-2020 11:08:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860794
Page 230 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/09/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Oct-30-2020 17:50:36 (UTC-03:00) City of
Buenos Airesnot applicable
Not Applicable
4Oct-30-2020 12:01:06 (UTC-03:00) City of
Buenos AiresChange information
4Oct-30-2020 11:08:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860795
Page 231 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-24-2020 08:43:03 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860796
Page 232 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-24-2020 08:43:03 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860797
Page 233 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-24-2020 08:43:03 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860798
Page 234 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-24-2020 08:43:03 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860799
Page 235 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-24-2020 08:43:03 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860800
Page 236 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5.bDec-16-2020 14:20:08 (UTC-03:00) City of
Buenos AiresLab normal range is under 41 UI/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860801
Page 237 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5.bDec-16-2020 14:20:08 (UTC-03:00) City of
Buenos AiresLab normal range is under 41 UI/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860802
Page 238 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5.bDec-16-2020 14:20:08 (UTC-03:00) City of
Buenos AiresLab normal range is under 41 UI/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860803
Page 239 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
5.bDec-16-2020 14:20:08 (UTC-03:00) City of
Buenos AiresLab normal range is under 41 UI/L
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860804
Page 240 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit on
Nov/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Queries
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormDec-18-2020 17:49:25 (UTC-03:00) City of
Buenos AiresSantiago
CorradettiWBC differentials are entered as percentages. No
absolute values are available in the source
document of the hematology lab test.
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860805
Page 241 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormJan-19-2021 13:10:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860806
Page 242 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Jan-19-2021 13:10:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860807
Page 243 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Jan-19-2021 13:10:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860808
Page 244 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Jan-19-2021 13:10:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860809
Page 245 of 588
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit on
Jan/16/2021Form: HOSPITALIZATION DETAILS - Comments
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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Jan-19-2021 13:10:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860810
Page 246 of 588
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormMar-10-2021 14:28:07 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860811
Page 247 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-26-2021 11:21:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana Estrada Approved Mar-16-2021 14:42:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, 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-10-2021 14:27:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-09-2021 16:54:23 (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.
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860812
Page 248 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
N/A Mar-09-2021 14:48:56 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-09-2021 14:14:21 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Alan Colombo N/A Mar-06-2021 11:15:34 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-05-2021 14:02:18 (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 Feb-26-2021 11:14:50 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860813
Page 249 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Approved Feb-18-2021 13:58:54 (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 Feb-13-2021 11:52:43 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Jan-22-2021 17:35:03 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-22-2021 12:27:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Jan-21-2021 22:36:42 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0860814
Page 250 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-16-2020 13:02:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-30-2020 15:41:20 (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-30-2020 08:14:34 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-27-2020 19:11:54 (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.
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860815
Page 251 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
N/A Nov-27-2020 14:31:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-25-2020 16:25:49 (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-22-2020 11:45:58 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-20-2020 09:48:49 (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-19-2020 13:16:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860816
Page 252 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Fernando
Polack Approved Nov-16-2020 11:11:53 (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 09:44:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-15-2020 18:06:42 (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-15-2020 10:36:29 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-08-2020 10:25:39 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860817
Page 253 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, SantiagoCorradetti, 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-06-2020 15:41:29 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-04-2020 16:46:44 (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-04-2020 08:40:07 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-30-2020 20:18:06 (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.
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860818
Page 254 of 588
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
N/A Oct-30-2020 16:30:19 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-30-2020 16:05:36 (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 Oct-29-2020 13:13:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 18:54:18 (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.
090177e196ae2eb4\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860819
Page 255 of 588
***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: 12311352 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Bac
…[truncated]