Document text
Page 1 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020650
Page 2 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/1/2020
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020651
Page 3 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10851018]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0020652
Page 4 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/1/2020
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020653
Page 5 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020654
Page 6 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020655
Page 7 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020656
Page 8 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020657
Page 9 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020658
Page 10 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Ventricle Hypertrophy]
Start Date: May/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: UNK/UNK/2000
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020659
Page 11 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tubal Ligation]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020660
Page 12 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/1/2020
2.Weight: [230.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [36.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020661
Page 13 of 423
***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, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/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:
Not Done: NOT DONE
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020662
Page 14 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/1/2020
2.Randomization Number: [41321]
3.Randomization Group: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020663
Page 15 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP5BT5]
5.bSample ID [BP5BT6]
5.cSample ID [BP5BT7]
5.dSample ID [BLD1V0]
5.eSample ID [BLD1V1]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020664
Page 16 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP5BSZ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020665
Page 17 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/1/2020 11:56
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020666
Page 18 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020667
Page 19 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/22/2020
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020668
Page 20 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?YES
Ongoing?
NO
Stop Date:
Aug/7/2020
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020669
Page 21 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020670
Page 22 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020671
Page 23 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020672
Page 24 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMD7R4]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020673
Page 25 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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/22/2020 11:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020674
Page 26 of 423
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020675
Page 27 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020676
Page 28 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020677
Page 29 of 423
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9N66]
5.bSample ID [BNVT8N]
5.cSample ID [BNVT8P]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020678
Page 30 of 423
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020679
Page 31 of 423
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
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 [BLD2GR]
5.bSample ID [BLD2GS]
5.cSample ID [BR6WJX]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020680
Page 32 of 423
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020681
Page 33 of 423
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020682
Page 34 of 423
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020683
Page 35 of 423
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020684
Page 36 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020685
Page 37 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/10/2020
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? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020686
Page 38 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020687
Page 39 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020688
Page 40 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020689
Page 41 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV10949]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020690
Page 42 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020691
Page 43 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020692
Page 44 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020693
Page 45 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020694
Page 46 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020695
Page 47 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020696
Page 48 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020697
Page 49 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Id
entifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020698
Page 50 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020699
Page 51 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020700
Page 52 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020701
Page 53 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020702
Page 54 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020703
Page 55 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020704
Page 56 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020705
Page 57 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020706
Page 58 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020707
Page 59 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020708
Page 60 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020709
Page 61 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
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FDA-CBER-2021-5683-0020710
Page 62 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Page 63 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020712
Page 64 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020713
Page 65 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020714
Page 66 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020715
Page 67 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020716
Page 68 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020717
Page 69 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020718
Page 70 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020719
Page 71 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020720
Page 72 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/8/2020
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 [BNZL2F]
5.bSample ID [BS7WBP]
5.cSample ID [BS7WBR]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020721
Page 73 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/08/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/8/2020
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020722
Page 74 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/08/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020723
Page 75 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/08/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/8/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [Reaction resolved the afternoon of 08Aug2020 per subject.]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020724
Page 76 of 423
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020725
Page 77 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020726
Page 78 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020727
Page 79 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020728
Page 80 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020729
Page 81 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020730
Page 82 of 423
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020731
Page 83 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020732
Page 84 of 423
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020733
Page 85 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020734
Page 86 of 423
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020735
Page 87 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020736
Page 88 of 423
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020737
Page 89 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020738
Page 90 of 423
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020739
Page 91 of 423
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020740
Page 92 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020741
Page 93 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020742
Page 94 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020743
Page 95 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020744
Page 96 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020745
Page 97 of 423
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020746
Page 98 of 423
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020747
Page 99 of 423
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020748
Page 100 of 423
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020749
Page 101 of 423
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020750
Page 102 of 423
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020751
Page 103 of 423
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020752
Page 104 of 423
***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: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020753
Page 105 of 423
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020754
Page 106 of 423
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020755
Page 107 of 423
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/21/2020
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020756
Page 108 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020757
Page 109 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020758
Page 110 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020759
Page 111 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Aug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020760
Page 112 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Aug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020761
Page 113 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Aug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020762
Page 114 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Aug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020763
Page 115 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Aug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020764
Page 116 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020765
Page 117 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020766
Page 118 of 423
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-22-2020 12:38:04 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020767
Page 119 of 423
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FormNov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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1Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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FDA-CBER-2021-5683-0020769
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2Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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3Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
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4Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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FDA-CBER-2021-5683-0020772
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
5Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
6Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
7Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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FDA-CBER-2021-5683-0020775
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
8Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
9Nov-10-2020 15:57:06 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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FormNov-10-2020 15:57:44 (UTC-06:00) Central
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Subject No: 10851018 Subject Initials: ---
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1Nov-10-2020 15:57:44 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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2Nov-10-2020 15:57:44 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
3Nov-10-2020 15:57:44 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Telehealth visit
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Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
4Nov-10-2020 15:57:44 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
FormNov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
1Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020784
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020785
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020786
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-10-2020 15:58:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-11-2020 16:06:30 (UTC-06:00) Central
Time (US & Canada)Claudia Alonzo
(pfe.calonzo)
3Nov-10-2020 15:58:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 15:59:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 15:59:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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FDA-CBER-2021-5683-0020792
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-10-2020 15:59:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-10-2020 15:59:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-10-2020 15:59:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020795
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
2Nov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
3Nov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
4Nov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
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5.aNov-10-2020 15:59:45 (UTC-06:00) Central
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5.bNov-10-2020 15:59:45 (UTC-06:00) Central
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.bNov-10-2020 15:59:45 (UTC-06:00) Central
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.cNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.cNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.cNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.dNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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5.dNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
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5.dNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
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5.dNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.eNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.eNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
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5.eNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
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5.eNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5 fNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5 fNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5 fNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5 fNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.gNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.gNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.gNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Back to Form
ItemDate User Comment
5.gNov-10-2020 15:59:45 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Back to Form
ItemDate User Comment
FormNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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ItemDate User Comment
1Nov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
2Nov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
3Nov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
4Nov-10-2020 16:00:39 (UTC-06:00) Central
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5.aNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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5.aNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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5.aNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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5.aNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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5.bNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.bNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.bNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.bNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.cNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.cNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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ItemDate User Comment
5.cNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
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Back to Form
ItemDate User Comment
5.cNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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Back to Form
ItemDate User Comment
5.dNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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FDA-CBER-2021-5683-0020851
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
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Site No: 1085 Site Name: (1085) Ventavia Research Group
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5.iNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.iNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.iNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
5.iNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
5.jNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
5.jNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
5.jNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
5.jNov-10-2020 16:00:39 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10851018 Subject Initials: ---
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ItemDate User Comment
FormNov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
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090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
1Nov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020875
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aNov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aNov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aNov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
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Page 230 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
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ItemDate User Comment
2.aNov-10-2020 16:01:10 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020879
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 16:01:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020880
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 16:01:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020881
Page 233 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aNov-10-2020 16:01:25 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020882
Page 234 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 16:01:47 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020883
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 16:01:47 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020884
Page 236 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-10-2020 16:01:47 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020885
Page 237 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-10-2020 16:01:47 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020886
Page 238 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020887
Page 239 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020888
Page 240 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020889
Page 241 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020890
Page 242 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020891
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020892
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-10-2020 16:02:07 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020893
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
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Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-10-2020 16:02:28 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020894
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-10-2020 16:02:28 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020895
Page 247 of 423
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-10-2020 16:02:28 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020896
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-10-2020 16:02:28 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020897
Page 249 of 423
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-10-2020 16:02:28 (UTC-06:00) Central
Time (US & Canada)Banika Ervin
(pfe.bervin)Not Done
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020898
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Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
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Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-01-2021 15:17:30 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020899
Page 251 of 423
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-01-2021 15:17:30 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020900
Page 252 of 423
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-01-2021 15:17:46 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020901
Page 253 of 423
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-01-2021 15:17:46 (UTC-06:00) Central
Time (US & Canada)Chyann Stewart
(pfe.cstewart)Not Applicable
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020902
Page 254 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Chyann Stewart N/A Mar-01-2021 15:17:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Dec-10-2020 15:55:18 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Claudia Alonzo N/A Dec-08-2020 10:23:29 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Nov-17-2020 14:06:58 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020903
Page 255 of 423
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Banika Ervin N/A Nov-10-2020 15:56:05 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Oct-12-2020 14:05:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
Angi Cox N/A Sep-21-2020 09:57:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Gregory Fuller Approved Sep-11-2020 16:13:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GregoryFuller, 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.
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020904
Page 256 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-01-2020 16:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-01-2020 16:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020905
Page 257 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-01-2020 16:52:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/1/2020Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020906
Page 258 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 01:26:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Closed Response satisfies
query
Aug-17-2020 20:02:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Query 1: Answered Unplanned Visit CFR
has been updated
Aug-17-2020 01:34:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Reissued:Opened PDQ: Requery:
Thank you for
response. As per
section 8.43 of CRF
Completion
Requirements, please
consider updating
"Was contact made?"
as 'Yes' and select the
appropriate Contact
Outcome option
present on
UNPLANNED VISIT
(UNPL) form.
Aug-14-2020 15:50:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Query 1: Answered Please clarify page to
address query
Aug-14-2020 07:51:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Reissued:Opened PDQ: Requery:
Thank you for
confirming Subject
was contacted via
phone. As per section
8.43 of CRF
Completion
Requirements, please
consider updating
"Was contact made?"
as 'Yes' and select the
appropriate Contact
Outcome option
present on Form.
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020907
Page 259 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-13-2020 08:23:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Query 1: Answered Subject was contacted
via phone. Symptoms
resolved. No
unplanned visit
required.
Aug-12-2020 05:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Opened PDQ: Subject has
reported Severe
symptoms/reaction in
eDiary data on
07Aug2020. Please
confirm if an
UNPLANNED
contact was made and
update the data as
appropriate
Aug-01-2020 16:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10851018Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-01-2020 16:52:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-01-2020 16:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-01-2020 16:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
(b) (6)
FDA-CBER-2021-5683-0020908
Page 260 of 423
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-01-2020 16:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
WHITEInitial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020909
Page 261 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-01-2020 16:53:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Aug/1/2020Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020910
Page 262 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive,
at randomization (depende
nt upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at rando
mization (dependent upon study staInitial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020911
Page 263 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
ge)
1.a Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proced
ures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020912
Page 264 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Participants who are willing and ab
le to comply with all scheduled visi
ts, vaccination plan, laboratory test
s, lifestyle considerations, and othe
r study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020913
Page 265 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Healthy participants who
are determined by medical
history, physical examinat
ion, and clinical judgment
of the investigator to be el
igible for inclusion in the
study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020914
Page 266 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
1.c Inclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020915
Page 267 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the
ICD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020916
Page 268 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
1.d Inclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Capable of giving personal signed i
nformed consent, which includes c
ompliance with the requirements an
d restrictions listed in the ICD and i
n this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020917
Page 269 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active s
uicidal ideation/behavior/l
ab abnormality that may i
ncrease the risk of study p
articipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Other medical or psychiatric condit
ion incl. recent (within past year) o
r active suicidal ideation/behavior/l
ab abnormality that may increase th
e risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020918
Page 270 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatiti
s B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020919
Page 271 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
2.b Exclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Known infection with human immu
nodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus
(HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component of
the study intervention(s)Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020920
Page 272 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or sev
ere allergic reaction (eg, anaphylaxi
s) to any component of the study in
tervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
EX03A00Initial Entry
2.d
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020921
Page 273 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
EX04A00Initial Entry
2.e
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020922
Page 274 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physi
cal examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020923
Page 275 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
2.e Exclusion Number:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examina
tionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-01-2020 16:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Banika
Ervin
(pfe.bervin)Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae3d8e\Final\Final On: 01-Apr-2021 04:37 (GMT)
FDA-CBER-2021-5683-0020924
Page 276 of 423
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1085 Site Name: (1085) Ventavia Research Group
Subject No: 10851018 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Bleeding diathesis or con
…[truncated]