Document text
Page 1 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888550
Page 2 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/29/2020
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888551
Page 3 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315324]
2.Birth Date: /1961
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888552
Page 4 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/29/2020
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888553
Page 5 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888554
Page 6 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888555
Page 7 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888556
Page 8 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/29/2020
2.Weight: [71.65]
3.Unit: kg
4.Height: [157.0]
5.Unit: cm
6.Body Mass Index: [29.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888557
Page 9 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/29/2020
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:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888558
Page 10 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/29/2020
2.Randomization Number: [246078]
3.Randomization Group: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888559
Page 11 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BPTCPF]
5.bSample ID [BPTCPG]
5.cSample ID [BPTCPH]
5.dSample ID [BRXT57]
5.eSample ID [BRXT58]
5.fSample ID [BRXT59]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888560
Page 12 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BPT8F5]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888561
Page 13 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/29/2020 17:53
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
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888562
Page 14 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888563
Page 15 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888564
Page 16 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888565
Page 17 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
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:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888566
Page 18 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPW9PZ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888567
Page 19 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 09:21
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
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888568
Page 20 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888569
Page 21 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BNTWGG]
5.bSample ID [BPW5S8]
5.cSample ID [BNTWH7]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888570
Page 22 of 423
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888571
Page 23 of 423
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888572
Page 24 of 423
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888573
Page 25 of 423
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888574
Page 26 of 423
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888575
Page 27 of 423
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888576
Page 28 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888577
Page 29 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/26/2020
2.Date of First Symptom Started: Dec/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/31/2021
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? NO
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
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888578
Page 30 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
5.bSymptoms - Other Text: [headache]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888579
Page 31 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/26/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
2.Jan/15/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
3.Jan/2/2021
SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888580
Page 32 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/26/2020
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: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888581
Page 33 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/15/2021
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: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888582
Page 34 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/2/2021
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: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888583
Page 35 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_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 [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888584
Page 36 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/26/2020
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 [BPW8DW]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888585
Page 37 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[3]
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?
YES
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888586
Page 38 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Jan/5/2021 YES Repeating Pages
2.HOSPITALIZATION STATUS ICU Jan/14/2021 NO
Discharge Date:
Jan/31/2021
Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888587
Page 39 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/5/2021
4.Ongoing? YES
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888588
Page 40 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Jan/14/2021
4.Ongoing? NO
Discharge Date:
Jan/31/2021
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888589
Page 41 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES MECHANICAL VEN
TILATION MECHANICAL VEN
TILATION Jan/16/2
021 Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888590
Page 42 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: RESPIRATORY TREATMENT
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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: MECHANICAL VENTILATION
4.Treatment: [MECHANICAL VENTILATION]
5.Start Date: Jan/16/2021
6.Ongoing? YES
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888591
Page 43 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
[COVID-19]
Date of Diagnosis:
Jan/15/2021
3.Toxicity Grade: 5
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888592
Page 44 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category of Clinical Ev
ent:Subcategory of Clinical EventDiagnosis Obtaine
dToxicity Gr
adeForm Instanc
e
1.SEVERE COVID-19 IL
LNESS SIGNIFICANT ACUTE RENAL DYS
FUNCTION YES
Diagnosis:
Acute Kidney Fa
ilure
Start Date:
Jan/14/2021
Ongoing?:
NO
End Date:
Jan/31/2021
5 Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888593
Page 45 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE RENAL DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[Acute Kidney Failure]
Start Date:
Jan/14/2021
Ongoing?:
NO
End Date:
Jan/31/2021
4.Toxicity Grade: 5
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888594
Page 46 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY "Hospital Privado Modelo". 1811 Jul
io Argentino Roca st. Vicente Lopez.
Buenos Aires Province Jan/31/
2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 [ ]
30 Alanine Ami
notransferase
_PX30 222
28 Aspartate Am
inotransferase
_PX28 329
35 Alkaline Phos
phatase_PX3
5 545
21 Bilirubin_PX
21 3.8
7
47 Blood Urea N
itrogen_PX47
132
48 Creatinine_P
X48 3.4
9 Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888595
Page 47 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
2.CLINICA
L CHEMI
STRY "Hospital Privado Modelo". 1811 Jul
io Argentino Roca st. Vicente Lopez.
Buenos Aires Province Jan/22/
2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 [ ]
30 Alanine Ami
notransferase
_PX30 144
28 Aspartate Am
inotransferase
_PX28 77
35 Alkaline Phos
phatase_PX3
5 245
21 Bilirubin_PX
21 1.1
9
47 Blood Urea N
itrogen_PX47
244
48 Creatinine_P
X48 6.8
1 Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888596
Page 48 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address ["Hospital Privado Modelo". 1811 Julio Argentino Roca st. Vicente
Lopez. Buenos Aires Province]
3.Collection Date: Jan/31/2021 Comments
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]
Test: Alanine Aminotransferase_PX30
Result: [222]
Not Done:
LNMT Low
[5]
High
[41]
Unit
U/L
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888597
Page 49 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [329]
Not Done:
LNMT Low
[5]
High
[35]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [545]
Not Done:
LNMT Low
[65]
High
[300]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [3.87]
Not Done:
LNMT Low
[0.5]
High
[1.20]
Unit
mg/dL
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888598
Page 50 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [132]
Not Done:
LNMT Low
[10]
High
[50]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [3.49]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888599
Page 51 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address ["Hospital Privado Modelo". 1811 Julio Argentino Roca st. Vicente Lopez.
Buenos Aires Province]
3.Collection Date: Jan/22/2021
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]
Test: Alanine Aminotransferase_PX30
Result: [144]
Not Done:
LNMT Low
[5]
High
[41]
Unit
U/L
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888600
Page 52 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [77]
Not Done:
LNMT Low
[5]
High
[35]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [245]
Not Done:
LNMT Low
[65]
High
[300]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.19]
Not Done:
LNMT Low
[0.5]
High
[1.20]
Unit
mg/dL
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888601
Page 53 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [244]
Not Done:
LNMT Low
[10]
High
[50]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [6.81]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888602
Page 54 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category
for Lab T
estVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY "Hospital Privado Modelo". 1811 Juli
o Argentino Roca st. Vicente Lopez.
Buenos Aires Jan/31/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglo
bin_PX1 8.4
2 Hematocr
it_PX2 25
3 Erythrocy
tes_PX3 2.8
1
5 Platelets_
PX5 16
7 Leukocyt
es_PX7 6
608 Neutrophi
ls_PX608
609 Eosinophi
ls_PX609
[ ]
612 Monocyte
s_PX612 [ ]
610 Basophils
_PX610 [ ]
611 Lymphoc
ytes_PX6
11 Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888603
Page 55 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
2.HEMATO
LOGY "Hospital Privado Modelo". 1811 Julio
Argentino Roca st. Vicente Lopez. Buen
os Aires Province Jan/22/
2021 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
1 Hemoglo
bin_PX1 6.5
2 Hematocr
it_PX2 20
3 Erythrocy
tes_PX3 2.1
2
5 Platelets_
PX5 101
7 Leukocyt
es_PX7 22.
9
608 Neutroph
ils_PX60
8 [ ]
609 Eosinoph
ils_PX60
9 [ ]
612 Monocyt
es_PX61
2 [ ]
610 Basophils
_PX610 [ ]
611 Lymphoc
ytes_PX6
11 [ ] Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888604
Page 56 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address ["Hospital Privado Modelo". 1811 Julio Argentino Roca st. Vicente
Lopez. Buenos Aires]
3.Collection Date: Jan/31/2021 Comments
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.4]
Not Done:
LNMT Low
[11]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [25]
Not Done:
LNMT Low
[37]
High
[54]
Unit
%
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888605
Page 57 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [2.81]
Not Done:
LNMT Low
[3.5]
High
[5.5]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [16]
Not Done:
LNMT Low
[130]
High
[450]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6]
Not Done:
LNMT Low
[4]
High
[10]
Unit
10^9/L
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888606
Page 58 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888607
Page 59 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888608
Page 60 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address ["Hospital Privado Modelo". 1811 Julio Argentino Roca st. Vicente Lopez.
Buenos Aires Province]
3.Collection Date: Jan/22/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [6.5]
Not Done:
LNMT Low
[11]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [20]
Not Done:
LNMT Low
[37]
High
[54]
Unit
%
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888609
Page 61 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [2.12]
Not Done:
LNMT Low
[3.5]
High
[5.5]
Unit
10^12/L
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [101]
Not Done:
LNMT Low
[130]
High
[450]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [22.9]
Not Done:
LNMT Low
[4]
High
[10]
Unit
10^9/L
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888610
Page 62 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888611
Page 63 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888612
Page 64 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Date: Vital Signs Details Form Instance
1.Unknown Record Identifier: Systolic: Diastolic:
1 100 60 Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888613
Page 65 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [100]
Diastolic: [60]
Respiratory Rate in
respirations/minute:[19]
Heart Rate in beats/minute: [92]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888614
Page 66 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Date: Vital Signs Details Form Instance
1.Unknown Record Identifier: Oxygen Saturation
1 83.0 Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888615
Page 67 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Date: Vital Signs Details Form Instance
2.Unknown Record Identifier: Oxygen Saturation
1 90.0 Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888616
Page 68 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [83.0]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888617
Page 69 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Unknown
//Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [90.0]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888618
Page 70 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Unknown Not Done 0.80 Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888619
Page 71 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Unknown
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): [0.80]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888620
Page 72 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Define
d IdentifierCategory for MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart Dat
eForm Instan
ce
1.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
2.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
3.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
4.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
5.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
6.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
7.Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
8.8 GENERAL CONCOMITAN
T MEDICATIONS NO Norepinephri
ne Unknown
Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888621
Page 73 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888622
Page 74 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888623
Page 75 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888624
Page 76 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888625
Page 77 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888626
Page 78 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888627
Page 79 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888628
Page 80 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [8]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Norepinephrine]
5.Start Date: Unknown
//Comments
6.Ongoing? Unknown Comments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888629
Page 81 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Jan/5/2021 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
bilateral pneumonia
Repeating Pages
2.Jan/13/2021 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
viral pneumonia
Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888630
Page 82 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/5/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[bilateral pneumonia]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888631
Page 83 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: 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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/13/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[viral pneumonia]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888632
Page 84 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888633
Page 85 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888634
Page 86 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888635
Page 87 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888636
Page 88 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888637
Page 89 of 423
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/31/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888638
Page 90 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888639
Page 91 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888640
Page 92 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888641
Page 93 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888642
Page 94 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888643
Page 95 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888644
Page 96 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888645
Page 97 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888646
Page 98 of 423
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888647
Page 99 of 423
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888648
Page 100 of 423
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888649
Page 101 of 423
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888650
Page 102 of 423
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888651
Page 103 of 423
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888652
Page 104 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Septic shock Dec/25/2020 19
:00 NO
End Date Time:
Jan/31/2021 20:30
Repeating
Pages
2.ADVERSE EVE
NT 2 Severe Covid-19 ill
ness Dec/25/2020 19
:00 NO
End Date Time:
Jan/31/2021 20:30
Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888653
Page 105 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Septic shock]
4.Start Date Time: Dec/25/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/31/2021 20:30
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
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
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888654
Page 106 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Severe Covid Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021160289]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888655
Page 107 of 423
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Severe Covid-19 illness]
4.Start Date Time: Dec/25/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/31/2021 20:30
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
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
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888656
Page 108 of 423
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[COVID-19 infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021160289]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888657
Page 109 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888658
Page 110 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888659
Page 111 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888660
Page 112 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888661
Page 113 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888662
Page 114 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888663
Page 115 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888664
Page 116 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888665
Page 117 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888666
Page 118 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888667
Page 119 of 423
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888668
Page 120 of 423
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888669
Page 121 of 423
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888670
Page 122 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888671
Page 123 of 423
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Jan/31/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Multiple Organ Failure]
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888672
Page 124 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/31/2021
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888673
Page 125 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-0888674
Page 126 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:05 (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.
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888675
Page 127 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 19:16:30 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0888676
Page 128 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-29-2020 19:16:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0888677
Page 129 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-20-2021 17:51:58 (UTC-03:00) City of
Buenos Aires
3Feb-11-2021 10:30:20 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888678
Page 130 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-20-2021 17:39:16 (UTC-03:00) City of
Buenos Aires
3Feb-11-2021 10:36:45 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888679
Page 131 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 11:30:13 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888680
Page 132 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 11:31:46 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888681
Page 133 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-12-2021 13:17:33 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888682
Page 134 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-24-2021 15:43:33 (UTC-03:00) City of
Buenos Airesnot specified in the epicrisis
1Feb-24-2021 15:43:14 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888683
Page 135 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Mar-05-2021 17:55:55 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888684
Page 136 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888685
Page 137 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888686
Page 138 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888687
Page 139 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888688
Page 140 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888689
Page 141 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888690
Page 142 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:02:55 (UTC-03:00) City of
Buenos AiresNot Applicable
6Feb-11-2021 14:02:10 (UTC-03:00) City of
Buenos Aires
6Feb-11-2021 11:34:11 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888691
Page 143 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888692
Page 144 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888693
Page 145 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888694
Page 146 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888695
Page 147 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888696
Page 148 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888697
Page 149 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:03:49 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888698
Page 150 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888699
Page 151 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888700
Page 152 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888701
Page 153 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888702
Page 154 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888703
Page 155 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888704
Page 156 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:04:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888705
Page 157 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888706
Page 158 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888707
Page 159 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888708
Page 160 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888709
Page 161 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888710
Page 162 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888711
Page 163 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:04:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888712
Page 164 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888713
Page 165 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888714
Page 166 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888715
Page 167 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888716
Page 168 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888717
Page 169 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888718
Page 170 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:05:28 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888719
Page 171 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888720
Page 172 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888721
Page 173 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888722
Page 174 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888723
Page 175 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888724
Page 176 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888725
Page 177 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:06:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888726
Page 178 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888727
Page 179 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888728
Page 180 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888729
Page 181 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888730
Page 182 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888731
Page 183 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888732
Page 184 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:01:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888733
Page 185 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Feb-11-2021 14:06:44 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888734
Page 186 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Feb-11-2021 14:06:55 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888735
Page 187 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-24-2021 17:01:05 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-24-2021 11:34:53 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-19-2021 13:57:48 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Santiago
Corradetti N/A Mar-18-2021 14:29:10 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888736
Page 188 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Fernando
Polack Approved Mar-17-2021 18:41:36 (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 Mar-17-2021 17:33:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina Rivera Approved Mar-17-2021 16:18:40 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, 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-03-2021 08:22:30 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-29-2021 16:09:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888737
Page 189 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-26-2021 12:34:40 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 16:12:12 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-27-2020 18:03:29 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 22:52:45 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888738
Page 190 of 423
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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.
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888739
Page 191 of 423
***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: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-29-2020 19:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-29-2020 19:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888740
Page 192 of 423
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020 19:16:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/29/2020Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888741
Page 193 of 423
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020 16:56:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12315324Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020 16:56:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1961Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020 19:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-29-2020 19:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-29-2020 19:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888742
Page 194 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-29-2020 19:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888743
Page 195 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-29-2020 19:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020 19:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020 19:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888744
Page 196 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
71.65Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
157.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888745
Page 197 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.1Initial Entry
7.a
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888746
Page 198 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020 19:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888747
Page 199 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888748
Page 200 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-29-2020 19:17:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888749
Page 201 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020 19:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020 19:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
246078Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888750
Page 202 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 19:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 19:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 17:07:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 19:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 19:17:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 17:07:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTCPFInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888751
Page 203 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 17:07:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTCPFInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 17:07:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTCPGInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 17:07:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTCPGInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 17:07:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTCPHInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 17:07:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTCPHInitial Entry
5.d
Date Location User Value Reason
Aug-31-2020 18:29:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXT57Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888752
Page 204 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 18:29:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXT57Initial Entry
5.e
Date Location User Value Reason
Aug-31-2020 18:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXT58Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 18:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXT58Initial Entry
5.f
Date Location User Value Reason
Aug-31-2020 18:30:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXT59Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-31-2020 18:30:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXT59Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888753
Page 205 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 13:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-29-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-29-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/29/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 13:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT8F5Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888754
Page 206 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 13:40:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPT8F5Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888755
Page 207 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/29/2020 17:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888756
Page 208 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-29-2020 19:18:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888757
Page 209 of 423
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-29-2020 19:18:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888758
Page 210 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 04:09:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Per site
confirmation
activated his diary
by mistake.
Oct-04-2020 19:03:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered According to the
investigator in
charge, the subject
in question is
asymptomatic and
that he activated his
diary due to covid
disease by mistake.
Thank you.
Oct-03-2020 08:31:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced any
of the following?”
for the COVID-19
symptoms or
diagnosis on
05SEP2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Sep-18-2020 14:14:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/18/2020Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888759
Page 211 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Identifier:
:1
Temperature: 36.4
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888760
Page 212 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 14:14:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888761
Page 213 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888762
Page 214 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 14:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888763
Page 215 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 11:19:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 11:19:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 11:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 11:19:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 11:19:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 11:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPW9PZInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888764
Page 216 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 11:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPW9PZInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888765
Page 217 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sep/18/2020 09:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City ofACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888766
Page 218 of 423
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
7. Route:
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 14:15:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888767
Page 219 of 423
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 14:33:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/22/2020Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888768
Page 220 of 423
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 14:33:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 14:33:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 17:17:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 14:33:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 14:33:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 17:17:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTWGGInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888769
Page 221 of 423
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 17:17:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BNTWGGInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 18:06:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPW5S8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 18:06:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPW5S8Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020 18:29:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTWH7Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 18:29:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BNTWH7Initial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888770
Page 222 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021 07:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-08-2021 20:41:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Closed erroneous
Feb-08-2021 10:40:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered The patient did not
make the
convalescence visit
because she was
hospitalized, on
January 31 she died.
Feb-08-2021 10:35:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered Please clarify this
query. Thank you.
Feb-04-2021 08:02:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Opened Invalid query hence
closed
Feb-04-2021 07:36:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened PDQ: Convalescent
visit is missing and
35+ days (40) have
passed since
COVID Illness
Visit. If visit
occurred record the
data as a matching
CONVA visit; if the
visit did not occur
attempt to schedule
the visit and obtain
the CONVA sample
else clarify.
Dec-27-2020 18:06:06
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0888771
Page 223 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-27-2020 18:03:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-27-2020 18:03:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-27-2020 18:03:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/26/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-27-2020 18:03:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888772
Page 224 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/26/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/25/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-17-2021 14:59:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-17-2021 14:23:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-17-2021 14:23:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
NO
Date of Last Symptom Resol
ved:
Jan/31/2021New Information
Feb-16-2021 16:56:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please clarify
whether the reported
symptoms are still
ongoing? If
symptoms have
ended, please
update ‘Symptoms
Ongoing’ on to
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888773
Page 225 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
‘NO’ and add Date
of Last Symptom
Resolved on the
CRF.
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Jan-26-2021 14:25:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESNew Information
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGHInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888774
Page 226 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Symptom
Present:NO
4.b Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:44:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 14:25:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021 14:25:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
YESNew Information
Jan-26-2021 12:34:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source
subject had cough,
please reconcile
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS OF
BREATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888775
Page 227 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.c Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-26-2021 14:25:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Symptoms: CHILLS
Symptom Present: YESNew Information
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888776
Page 228 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.d Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-26-2021 14:44:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 14:25:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021 14:25:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
YESNew Information
Jan-26-2021 12:35:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source
subject had chills ,
please reconcile
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREA
SED MUSCLE PAI
N
Symptom
Present:NOInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888777
Page 229 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.e Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888778
Page 230 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888779
Page 231 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4.h Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-27-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888780
Page 232 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Dec-27-2020 18:04:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: fatigueInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-26-2021 14:44:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 14:26:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Query 1: Answered Changed data per
query
Jan-26-2021 12:36:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source
subject also had
headache, please
reconcile
Dec-27-2020 18:04:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
5.b
Date Location User Value Reason
Jan-26-2021 14:26:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Symptoms - Other: headacheInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Jan-26-2021 14:26:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
headacheInitial Entry
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888781
Page 233 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Dec-27-2020 18:05:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0888782
Page 234 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Jan-20-2021 12:52:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888783
Page 235 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315324 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Jan-21-2021 15:10:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiForm Created
090177e196ae2edb\Final\Final On: 01-Apr-2021 03:25 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0888784
Page 236 of 423
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/26/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Tr
…[truncated]