Document text
Page 1 of 486
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847510
Page 2 of 486
***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: 12261094 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
Aug/11/2020
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847511
Page 3 of 486
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Demography
1.Subject ID [12261094]
2.Birth Date: 1989
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0847512
Page 4 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847513
Page 5 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and
85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon
study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination,
and clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847514
Page 6 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847515
Page 7 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective family
members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847516
Page 8 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847517
Page 9 of 486
***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: 12261094 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:[Asthma]
Start Date: Sep/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to dipyrone]
Start Date: Jul/UNK/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nephrolithiasis]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847518
Page 10 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [81.0]
3.Unit: kg
4.Height: [158.6]
5.Unit: cm
6.Body Mass Index: [32.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847519
Page 11 of 486
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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: Aug/11/2020
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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847520
Page 12 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [46257]
3.Randomization Group: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847521
Page 13 of 486
***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: 12261094 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:
Aug/11/2020
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 [BP5H8Y]
5.bSample ID [BP5H8H]
5.cSample ID [BP5H8X]
5.dSample ID [BLCTF7]
5.eSample ID [BLCTF6]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847522
Page 14 of 486
***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: 12261094 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:
Aug/11/2020
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 [BP5H74]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847523
Page 15 of 486
***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: 12261094 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: Aug/11/2020 13:48
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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847524
Page 16 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847525
Page 17 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847526
Page 18 of 486
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/17/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/17/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847527
Page 19 of 486
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847528
Page 20 of 486
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: FOREHEAD
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847529
Page 21 of 486
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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: Sep/1/2020
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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847530
Page 22 of 486
***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: 12261094 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:
Sep/1/2020
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 [BP9DRG]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847531
Page 23 of 486
***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: 12261094 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: Sep/1/2020 14:15
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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847532
Page 24 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847533
Page 25 of 486
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847534
Page 26 of 486
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847535
Page 27 of 486
***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: 12261094 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:
Sep/30/2020
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 [BP7XM6]
5.bSample ID [BLC0HT]
5.cSample ID [BLC0HS]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847536
Page 28 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847537
Page 29 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/22/2020
2.Date of First Symptom Started: Sep/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/29/2020
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? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? YES
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847538
Page 30 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847539
Page 31 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847540
Page 32 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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 Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847541
Page 33 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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:[The nasal swab was performed on site. The barcode is attached on "SWAB PFE"
item.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847542
Page 34 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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:
Sep/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP7X7C]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847543
Page 35 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847544
Page 36 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847545
Page 37 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847546
Page 38 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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: 2
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847547
Page 39 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847548
Page 40 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847549
Page 41 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for L
ab TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able
Not Applicable Not Applic
able Not Applic
able Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847550
Page 42 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847551
Page 43 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847552
Page 44 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847553
Page 45 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847554
Page 46 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 Applicable
Not Applicable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847555
Page 47 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847556
Page 48 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847557
Page 49 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847558
Page 50 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847559
Page 51 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847560
Page 52 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847561
Page 53 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
1.Sep/22/2020 Record Identifier: Systolic: Diastolic:
1 107 67 Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847562
Page 54 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [107]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [79]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847563
Page 55 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Date: Vital Signs Details Form Instance
1.Sep/22/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847564
Page 56 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847565
Page 57 of 486
***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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847566
Page 58 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847567
Page 59 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847568
Page 60 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847569
Page 61 of 486
***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: 12261094 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 Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847570
Page 62 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 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 Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847571
Page 63 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847572
Page 64 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/15/2020
2.Date of First Symptom Started: Dec/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/15/2020
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? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847573
Page 65 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847574
Page 66 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Type Form Instance
1.Not Applicable Not Applicabl
e Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847575
Page 67 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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 Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847576
Page 68 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW90986]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847577
Page 69 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847578
Page 70 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847579
Page 71 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847580
Page 72 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847581
Page 73 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847582
Page 74 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847583
Page 75 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847584
Page 76 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847585
Page 77 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847586
Page 78 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847587
Page 79 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847588
Page 80 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847589
Page 81 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847590
Page 82 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847591
Page 83 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847592
Page 84 of 486
***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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847593
Page 85 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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): [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847594
Page 86 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847595
Page 87 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847596
Page 88 of 486
***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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847597
Page 89 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847598
Page 90 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847599
Page 91 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/11/2020Form: 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: 12261094 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/11/2020
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 [BR697H]
5.bSample ID [BS2XK0]
5.cSample ID [BS2XJZ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847600
Page 92 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/04/2021Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847601
Page 93 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/04/2021Form: 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: 12261094 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:
Feb/4/2021
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 [BR6867]
5.bSample ID [BSCW48]
5.cSample ID [BSCW47]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847602
Page 94 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847603
Page 95 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Unplanned Assessments
1.Assessments
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847604
Page 96 of 486
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847605
Page 97 of 486
***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: 12261094 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: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847606
Page 98 of 486
***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: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847607
Page 99 of 486
***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: 12261094 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 [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847608
Page 100 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847609
Page 101 of 486
***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: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847610
Page 102 of 486
***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: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847611
Page 103 of 486
***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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847612
Page 104 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847613
Page 105 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847614
Page 106 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847615
Page 107 of 486
***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, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847616
Page 108 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847617
Page 109 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/4/2021
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847618
Page 110 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847619
Page 111 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847620
Page 112 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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: Mar/11/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847621
Page 113 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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:
Mar/11/2021
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 [BRGZ3L]
5.bSample ID [BRXW7T]
5.cSample ID [BRXW7V]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847622
Page 114 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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:
Mar/11/2021
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 [BRGZ4D]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847623
Page 115 of 486
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/11/2021 10:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847624
Page 116 of 486
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847625
Page 117 of 486
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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:
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847626
Page 118 of 486
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 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 [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847627
Page 119 of 486
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847628
Page 120 of 486
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847629
Page 121 of 486
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847630
Page 122 of 486
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847631
Page 123 of 486
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847632
Page 124 of 486
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847633
Page 125 of 486
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847634
Page 126 of 486
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847635
Page 127 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Worsening of Nephroli
thiasis Dec/21/2020 UNK:
UNK NO
End Date Time:
Jan/22/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Urinary tract infection Dec/29/2020 UNK:
UNK NO
End Date Time:
Jan/5/2021 UNK:UNK
Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847636
Page 128 of 486
***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: 12261094 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)[Worsening of Nephrolithiasis]
4.Start Date Time: Dec/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 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
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:
[Nephrolithiasis]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847637
Page 129 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2021006926]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847638
Page 130 of 486
***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: 12261094 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)[Urinary tract infection]
4.Start Date Time: Dec/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Worsening of nephrolithiasis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847639
Page 131 of 486
***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: 12261094 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[ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847640
Page 132 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847641
Page 133 of 486
***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: 12261094 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[ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847642
Page 134 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847643
Page 135 of 486
***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: 12261094 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: //
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847644
Page 136 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847645
Page 137 of 486
***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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847646
Page 138 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847647
Page 139 of 486
***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: 12261094 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?
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847648
Page 140 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847649
Page 141 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847650
Page 142 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847651
Page 143 of 486
***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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847652
Page 144 of 486
***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: 12261094 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: [ ]
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847653
Page 145 of 486
***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: 12261094 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 Sep/30/2020
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847654
Page 146 of 486
***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: 12261094 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
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847655
Page 147 of 486
***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: 12261094 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-12-2021 09:27:11 (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.
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0847656
Page 148 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847657
Page 149 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847658
Page 150 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847659
Page 151 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847660
Page 152 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847661
Page 153 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847662
Page 154 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847663
Page 155 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847664
Page 156 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847665
Page 157 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Sep-22-2020 16:49:24 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847666
Page 158 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847667
Page 159 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847668
Page 160 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847669
Page 161 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847670
Page 162 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847671
Page 163 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847672
Page 164 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Sep-22-2020 16:55:25 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847673
Page 165 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:56:29 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847674
Page 166 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:56:29 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847675
Page 167 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:56:29 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847676
Page 168 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:56:29 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847677
Page 169 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:56:29 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847678
Page 170 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847679
Page 171 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847680
Page 172 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847681
Page 173 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847682
Page 174 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847683
Page 175 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847684
Page 176 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847685
Page 177 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847686
Page 178 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847687
Page 179 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847688
Page 180 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847689
Page 181 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847690
Page 182 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847691
Page 183 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847692
Page 184 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847693
Page 185 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847694
Page 186 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847695
Page 187 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847696
Page 188 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847697
Page 189 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847698
Page 190 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847699
Page 191 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847700
Page 192 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847701
Page 193 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847702
Page 194 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847703
Page 195 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847704
Page 196 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847705
Page 197 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847706
Page 198 of 486
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Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847707
Page 199 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847708
Page 200 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847709
Page 201 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847710
Page 202 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:56:44 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847711
Page 203 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847712
Page 204 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847713
Page 205 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847714
Page 206 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847715
Page 207 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847716
Page 208 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847717
Page 209 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847718
Page 210 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847719
Page 211 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.aSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847720
Page 212 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847721
Page 213 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847722
Page 214 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847723
Page 215 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.bSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847724
Page 216 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847725
Page 217 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847726
Page 218 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847727
Page 219 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.cSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847728
Page 220 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847729
Page 221 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847730
Page 222 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847731
Page 223 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.dSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847732
Page 224 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847733
Page 225 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847734
Page 226 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847735
Page 227 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.eSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b)
(b) (4)
FDA-CBER-2021-5683-0847736
Page 228 of 486
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847737
Page 229 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847738
Page 230 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847739
Page 231 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.fSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847740
Page 232 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847741
Page 233 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847742
Page 234 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847743
Page 235 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.gSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847744
Page 236 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847745
Page 237 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847746
Page 238 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847747
Page 239 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.hSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847748
Page 240 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847749
Page 241 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847750
Page 242 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847751
Page 243 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.iSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847752
Page 244 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847753
Page 245 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847754
Page 246 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847755
Page 247 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5.jSep-22-2020 16:57:48 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847756
Page 248 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:58:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847757
Page 249 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:58:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847758
Page 250 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:58:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847759
Page 251 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:58:54 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847760
Page 252 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847761
Page 253 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847762
Page 254 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847763
Page 255 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847764
Page 256 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847765
Page 257 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847766
Page 258 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Sep-22-2020 16:59:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847767
Page 259 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormSep-22-2020 16:59:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847768
Page 260 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Sep-22-2020 16:59:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847769
Page 261 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Sep-22-2020 16:59:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847770
Page 262 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Sep-22-2020 16:59:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847771
Page 263 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/22/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Sep-22-2020 16:59:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847772
Page 264 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847773
Page 265 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847774
Page 266 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
2Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847775
Page 267 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
3Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847776
Page 268 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
4Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847777
Page 269 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
5Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847778
Page 270 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
6Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847779
Page 271 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
7Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847780
Page 272 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
8Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847781
Page 273 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: 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: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
9Dec-17-2020 17:44:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847782
Page 274 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/15/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
FormDec-18-2020 14:01:52 (UTC-03:00) City of
Buenos Aires
FormDec-16-2020 17:44:20 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847783
Page 275 of 486
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e
Servicos Medicos Ltda
Subject No: 12261094 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:54
Back to Form
ItemDate User Comment
1.aDec-18-2020 14:01:52 (UTC-03:00) City of
Buenos Aires
1.aDec-16-2020 17:44:20 (UTC-03:00) City of
Buenos AiresUnknown
090177e196ae404f\Final\Final On: 01-Apr-2021 05:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0847784
Page 276 of 486
***Confi
…[truncated]