125742 S1 M5 CRF c4591001 1226 12262089

Document text

Page 1 of 434
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855382
Page 2 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/6/2020
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855383
Page 3 of 434
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12262089]
2.Birth Date: 1975
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
WHITE
6.Racial Designation:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0855384
Page 4 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855385
Page 5 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855386
Page 6 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855387
Page 7 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral tubal ligation]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855388
Page 8 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855389
Page 9 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
2.Weight: [56.0]
3.Unit: kg
4.Height: [161.0]
5.Unit: cm
6.Body Mass Index: [21.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855390
Page 10 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
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:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855391
Page 11 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/6/2020
2.Randomization Number: [103777]
3.Randomization Group: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855392
Page 12 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BPWZ3D]
5.bSample ID [BRVC5K]
5.cSample ID [BRVC5J]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855393
Page 13 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BPVZ36]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855394
Page 14 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: Oct/6/2020 11:40
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
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855395
Page 15 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855396
Page 16 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855397
Page 17 of 434
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855398
Page 18 of 434
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/6/2020
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:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855399
Page 19 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BR690Z]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855400
Page 20 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: Nov/6/2020 10:16
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
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855401
Page 21 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855402
Page 22 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
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 [BRGTGH]
5.bSample ID [BSF1YT]
5.cSample ID [BSF1YV]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855403
Page 23 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855404
Page 24 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855405
Page 25 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855406
Page 26 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855407
Page 27 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855408
Page 28 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855409
Page 29 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855410
Page 30 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom Started: Oct/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855411
Page 31 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855412
Page 32 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855413
Page 33 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855414
Page 34 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:[swab collection performed at the site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855415
Page 35 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWZF1]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855416
Page 36 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855417
Page 37 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855418
Page 38 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855419
Page 39 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855420
Page 40 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855421
Page 41 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855422
Page 42 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855423
Page 43 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855424
Page 44 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855425
Page 45 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855426
Page 46 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855427
Page 47 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855428
Page 48 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855429
Page 49 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855430
Page 50 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855431
Page 51 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855432
Page 52 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855433
Page 53 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855434
Page 54 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Oct/9/2020 Record Identifier: Systolic: Diastolic:
1  128  82 Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855435
Page 55 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [128]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [56]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855436
Page 56 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Oct/9/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855437
Page 57 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855438
Page 58 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855439
Page 59 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855440
Page 60 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855441
Page 61 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
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
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855442
Page 62 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855443
Page 63 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855444
Page 64 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855445
Page 65 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/28/2020
2.Date of First Symptom Started: Dec/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855446
Page 66 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Coryza]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855447
Page 67 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855448
Page 68 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855449
Page 69 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 was collected on site, recorded at swab pfe]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0855450
Page 70 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP990J]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855451
Page 71 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855452
Page 72 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855453
Page 73 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855454
Page 74 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855455
Page 75 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855456
Page 76 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855457
Page 77 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855458
Page 78 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855459
Page 79 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855460
Page 80 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855461
Page 81 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/28/2020 Record Identifier: Systolic: Diastolic:
1  131  77 Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855462
Page 82 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [131]
Diastolic: [77]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [76]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855463
Page 83 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
 1.Dec/28/2020 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855464
Page 84 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855465
Page 85 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855466
Page 86 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855467
Page 87 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855468
Page 88 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855469
Page 89 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855470
Page 90 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855471
Page 91 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855472
Page 92 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BR691S]
5.bSample ID [BS2XCB]
5.cSample ID [BS2XCC]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855473
Page 93 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/27/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855474
Page 94 of 434
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRH0HD]
5.bSample ID [BSF3ZM]
5.cSample ID [BSF3ZN]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855475
Page 95 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855476
Page 96 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855477
Page 97 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855478
Page 98 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855479
Page 99 of 434
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855480
Page 100 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855481
Page 101 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855482
Page 102 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855483
Page 103 of 434
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855484
Page 104 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855485
Page 105 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855486
Page 106 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855487
Page 107 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855488
Page 108 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855489
Page 109 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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 [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855490
Page 110 of 434
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855491
Page 111 of 434
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855492
Page 112 of 434
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855493
Page 113 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Urinary tract infec
tion Oct/18/2020 06
:00 NO
End Date Time:
Oct/22/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Pain at injection si
te Nov/6/2020 21:
00 NO
End Date Time:
Nov/7/2020 UNK:UNK
 Repeating
Pages
 3.ADVERSE EVE
NT 3  Malaise  Nov/6/2020 21:
00 NO
End Date Time:
Nov/6/2020 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVE
NT 4  Chills  Nov/6/2020 21:
00 NO
End Date Time:
Nov/6/2020 UNK:UNK
 Repeating
Pages
 5.ADVERSE EVE
NT 5  Muscle pain  Nov/6/2020 21:
00 NO
End Date Time:
Nov/6/2020 UNK:UNK
 Repeating
Pages
 6.ADVERSE EVE
NT 6  Nausea  Nov/6/2020 21:
00 NO
End Date Time:
Nov/6/2020 UNK:UNK
 Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855494
Page 114 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Urinary tract infection]
4.Start Date Time: Oct/18/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/22/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855495
Page 115 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[urinary infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437602]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855496
Page 116 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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)[Pain at injection site]
4.Start Date Time: Nov/6/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855497
Page 117 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855498
Page 118 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Malaise]
4.Start Date Time: Nov/6/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855499
Page 119 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855500
Page 120 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Nov/6/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855501
Page 121 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855502
Page 122 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle pain]
4.Start Date Time: Nov/6/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855503
Page 123 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855504
Page 124 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Nov/6/2020 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855505
Page 125 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855506
Page 126 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855507
Page 127 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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[ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855508
Page 128 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855509
Page 129 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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: //
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855510
Page 130 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855511
Page 131 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855512
Page 132 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855513
Page 133 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
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?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855514
Page 134 of 434
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855515
Page 135 of 434
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855516
Page 136 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855517
Page 137 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855518
Page 138 of 434
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855519
Page 139 of 434
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855520
Page 140 of 434
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855521
Page 141 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855522
Page 142 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855523
Page 143 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-04-2021 12:12:52 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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.
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4)
FDA-CBER-2021-5683-0855524
Page 144 of 434
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-06-2020 13:20:41 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855525
Page 145 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855526
Page 146 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855527
Page 147 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855528
Page 148 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855529
Page 149 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855530
Page 150 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855531
Page 151 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855532
Page 152 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855533
Page 153 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855534
Page 154 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Oct-09-2020 16:39:09 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855535
Page 155 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855536
Page 156 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855537
Page 157 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855538
Page 158 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855539
Page 159 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855540
Page 160 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855541
Page 161 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Oct-09-2020 16:40:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855542
Page 162 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:41:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855543
Page 163 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:41:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855544
Page 164 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:41:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855545
Page 165 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:41:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855546
Page 166 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:41:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855547
Page 167 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855548
Page 168 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855549
Page 169 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855550
Page 170 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855551
Page 171 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855552
Page 172 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855553
Page 173 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855554
Page 174 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855555
Page 175 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855556
Page 176 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855557
Page 177 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855558
Page 178 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855559
Page 179 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855560
Page 180 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855561
Page 181 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855562
Page 182 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855563
Page 183 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855564
Page 184 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855565
Page 185 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855566
Page 186 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855567
Page 187 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855568
Page 188 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855569
Page 189 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855570
Page 190 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855571
Page 191 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855572
Page 192 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855573
Page 193 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855574
Page 194 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855575
Page 195 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855576
Page 196 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855577
Page 197 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855578
Page 198 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855579
Page 199 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:42 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855580
Page 200 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855581
Page 201 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855582
Page 202 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855583
Page 203 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855584
Page 204 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855585
Page 205 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855586
Page 206 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855587
Page 207 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855588
Page 208 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855589
Page 209 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855590
Page 210 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855591
Page 211 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855592
Page 212 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855593
Page 213 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855594
Page 214 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855595
Page 215 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855596
Page 216 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855597
Page 217 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855598
Page 218 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855599
Page 219 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855600
Page 220 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855601
Page 221 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855602
Page 222 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855603
Page 223 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855604
Page 224 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855605
Page 225 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855606
Page 226 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855607
Page 227 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855608
Page 228 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 fOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855609
Page 229 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855610
Page 230 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855611
Page 231 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855612
Page 232 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855613
Page 233 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 hOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855614
Page 234 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 hOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855615
Page 235 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 hOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855616
Page 236 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5 hOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855617
Page 237 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855618
Page 238 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855619
Page 239 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855620
Page 240 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855621
Page 241 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855622
Page 242 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855623
Page 243 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855624
Page 244 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jOct-09-2020 16:41:57 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855625
Page 245 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:42:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855626
Page 246 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:42:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855627
Page 247 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:42:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855628
Page 248 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:42:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855629
Page 249 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855630
Page 250 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855631
Page 251 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855632
Page 252 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855633
Page 253 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855634
Page 254 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855635
Page 255 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Oct-09-2020 16:42:59 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855636
Page 256 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormOct-09-2020 16:43:12 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855637
Page 257 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Oct-09-2020 16:43:12 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855638
Page 258 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Oct-09-2020 16:43:12 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855639
Page 259 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Oct-09-2020 16:43:12 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855640
Page 260 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Oct-09-2020 16:43:12 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855641
Page 261 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855642
Page 262 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855643
Page 263 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855644
Page 264 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855645
Page 265 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855646
Page 266 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855647
Page 267 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855648
Page 268 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855649
Page 269 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855650
Page 270 of 434
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Dec/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Dec-29-2020 10:15:53 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855651
Page 271 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cristiano
Zerbini Approved Mar-04-2021 12:12:52 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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-17-2021 15:31:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Jan-30-2021 11:10:10 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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-27-2021 15:50:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0855652
Page 272 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Cristiano
Zerbini Approved Jan-23-2021 08:42:00 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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-10-2020 16:50:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Cristiano
Zerbini Approved Nov-13-2020 11:36:00 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CristianoZerbini, 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.
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0855653
Page 273 of 434
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-06-2020 13:17:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-06-2020 13:17:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855654
Page 274 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-06-2020 13:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/6/2020Initial Entry
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855655
Page 275 of 434
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-06-2020 13:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12262089Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-06-2020 13:17:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-06-2020 13:20:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-06-2020 13:20:00
(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
Oct-06-2020 13:20:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERI
CAN
WHITEInitial Entry
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855656
Page 276 of 434
***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 13:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae4061\Final\Final On: 01-Apr-2021 05:38 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0855657
Page 277 of 434
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12262089 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-06-2020 13:20:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2. Phase of Dispos
…[truncated]