Document text
Page 1 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137034
Page 2 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137035
Page 3 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131190]
2.Birth Date: 1974
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:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137036
Page 4 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137037
Page 5 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137038
Page 6 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137039
Page 7 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MIGRAINE HEADACHES]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TARLOV CYST]
Start Date: Dec/UNK/2019
Ongoing: YES
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137040
Page 8 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [65.7]
3.Unit: kg
4.Height: [167.6]
5.Unit: cm
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137041
Page 9 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137042
Page 10 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [49018]
3.Randomization Group: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137043
Page 11 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BPYWD2]
5.bSample ID [BPYWD3]
5.cSample ID [BPYWD4]
5.dSample ID [BNWHHW]
5.eSample ID [BNWHHX]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137044
Page 12 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BM8S4N]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137045
Page 13 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/17/2020 10:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137046
Page 14 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
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FDA-CBER-2021-5683-0137047
Page 15 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137048
Page 16 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137049
Page 17 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137050
Page 18 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137051
Page 19 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137052
Page 20 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPC2SS]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137053
Page 21 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 14:07
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137054
Page 22 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137055
Page 23 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137056
Page 24 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137057
Page 25 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPC2HL]
5.bSample ID [BPC2HM]
5.cSample ID [BPC2HN]
5.dSample ID [BS6ZBY]
5.eSample ID [BS6ZBZ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137058
Page 26 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137059
Page 27 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Recorded with convalescent visit.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137060
Page 28 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137061
Page 29 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137062
Page 30 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137063
Page 31 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137064
Page 32 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137065
Page 33 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/8/2021
2.Date of First Symptom Started: Jan/24/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/10/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137066
Page 34 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137067
Page 35 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/8/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137068
Page 36 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/8/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT UNKNOWN] Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137069
Page 37 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV08947]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137070
Page 38 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[visit conducted via telehealth]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137071
Page 39 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137072
Page 40 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137073
Page 41 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137074
Page 42 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[CLOSTRIDIUM DIFFICLE INFECTION]
Date of Diagnosis:
Jan/27/2021
3.Toxicity Grade: 3
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137075
Page 43 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137076
Page 44 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137077
Page 45 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137078
Page 46 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category f
or Lab Te
stVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
2.CLINICA
L CHEMI
STRY ORLANDO REGIONAL MEDIC
AL CENTER, 1414 KUHL AVE.
ORLANDO, FL 32806 Mar/9/
2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 1.0
30 Alanine Ami
notransferase
_PX30 15
28 Aspartate Am
inotransferase
_PX28 21
35 Alkaline Phos
phatase_PX3
5 92
21 Bilirubin_PX
21 0.5
47 Blood Urea N
itrogen_PX47
15
48 Creatinine_P
X48 0.7
6 Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137079
Page 47 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137080
Page 48 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137081
Page 49 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137082
Page 50 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137083
Page 51 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL AVE.
ORLANDO, FL 32806]
3.Collection Date: Mar/9/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [1.0]
Not Done:
LNMT Low
[ ]
High
[9.9]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [15]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137084
Page 52 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [21]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [92]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137085
Page 53 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [15]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.76]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137086
Page 54 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137087
Page 55 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category
for Lab T
estVendor Name (DERIVED)Collecti
on Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
2.HEMATO
LOGY ORLANDO REGIONAL MEDICAL
CENTER, 1414 KUHL AVE. ORLA
NDO, FL 32806 Mar/9/2
021 BLOO
D Sponsor-D
efined Iden
tifierTest:Res
ult:
1 Hemoglo
bin_PX1 13.
4
2 Hematocr
it_PX2 46.
1
3 Erythrocy
tes_PX3 4.0
6
5 Platelets_
PX5 273
7 Leukocyt
es_PX7 10.
9
608 Neutroph
ils_PX60
8 6.8
609 Eosinoph
ils_PX60
9 0.3
612 Monocyt
es_PX61
2 0.5
610 Basophils
_PX610 0.1
611 Lymphoc
ytes_PX6
11 3.3 Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137088
Page 56 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137089
Page 57 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137090
Page 58 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137091
Page 59 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137092
Page 60 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137093
Page 61 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137094
Page 62 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [ORLANDO REGIONAL MEDICAL CENTER, 1414 KUHL AVE.
ORLANDO, FL 32806]
3.Collection Date: Mar/9/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.4]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [46.1]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137095
Page 63 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.06]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [273]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [10.9]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137096
Page 64 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [6.8]
Not Done:
LNMT Low
[1.5]
High
[7.5]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.5]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137097
Page 65 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 20-Feb-2021 02:18 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [3.3]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137098
Page 66 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
1 Not Applicable Not Applicable Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
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Page 67 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
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Page 68 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137101
Page 69 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137102
Page 70 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137103
Page 71 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137104
Page 72 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137105
Page 73 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137106
Page 74 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137107
Page 75 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137108
Page 76 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137109
Page 77 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BV0XKZ]
5.bSample ID [BV0XL0]
5.cSample ID [BV0XL1]
5.dSample ID [BVSYRG]
5.eSample ID [BVSYRH]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137110
Page 78 of 431
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137111
Page 79 of 431
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137112
Page 80 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137113
Page 81 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0137114
Page 82 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137115
Page 83 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137116
Page 84 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 kidney stones Jan/4/2021 U
NK:UNK NO
End Date Time:
Jan/5/2021 UNK:U
NK
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 CLOSTRIDIUM DIFFI
CILE INFECTION Jan/27/2021
11:25 YES Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137117
Page 85 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[kidney stones]
4.Start Date Time: Jan/4/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137118
Page 86 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[kidney stone]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021018675]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137119
Page 87 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CLOSTRIDIUM DIFFICILE INFECTION ]
4.Start Date Time: Jan/27/2021 11:25
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[C-DIFF]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137120
Page 88 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137121
Page 89 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137122
Page 90 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137123
Page 91 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137124
Page 92 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: //
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137125
Page 93 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137126
Page 94 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137127
Page 95 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
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FDA-CBER-2021-5683-0137128
Page 96 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137129
Page 97 of 431
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137130
Page 98 of 431
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137131
Page 99 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137132
Page 100 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137133
Page 101 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137134
Page 102 of 431
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137135
Page 103 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137136
Page 104 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137137
Page 105 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137138
Page 106 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137139
Page 107 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137140
Page 108 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137141
Page 109 of 431
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137142
Page 110 of 431
***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, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137143
Page 111 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137144
Page 112 of 431
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137145
Page 113 of 431
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137146
Page 114 of 431
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137147
Page 115 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137148
Page 116 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia Brown Approved Mar-12-2021 11:18:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, 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.
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137149
Page 117 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-17-2020 14:37:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137150
Page 118 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe.mstephens)
FormFeb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137151
Page 119 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
1Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137152
Page 120 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
2Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137153
Page 121 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
3Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137154
Page 122 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
4Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137155
Page 123 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
5Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137156
Page 124 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
6Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137157
Page 125 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
7Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137158
Page 126 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
8Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137159
Page 127 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Mar-01-2021 15:19:48 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)
9Feb-09-2021 10:44:19 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137160
Page 128 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137161
Page 129 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137162
Page 130 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137163
Page 131 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137164
Page 132 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137165
Page 133 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137166
Page 134 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-09-2021 10:41:17 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137167
Page 135 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:42:36 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137168
Page 136 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:42:36 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137169
Page 137 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:42:36 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137170
Page 138 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:42:36 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137171
Page 139 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:42:36 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137172
Page 140 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137173
Page 141 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137174
Page 142 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137175
Page 143 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137176
Page 144 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137177
Page 145 of 431
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137178
Page 146 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137179
Page 147 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137180
Page 148 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137181
Page 149 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137182
Page 150 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137183
Page 151 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137184
Page 152 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137185
Page 153 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137186
Page 154 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137187
Page 155 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137188
Page 156 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137189
Page 157 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137190
Page 158 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137191
Page 159 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137192
Page 160 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137193
Page 161 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137194
Page 162 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137195
Page 163 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137196
Page 164 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137197
Page 165 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137198
Page 166 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137199
Page 167 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137200
Page 168 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137201
Page 169 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137202
Page 170 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137203
Page 171 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137204
Page 172 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:04 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137205
Page 173 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137206
Page 174 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137207
Page 175 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137208
Page 176 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137209
Page 177 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137210
Page 178 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137211
Page 179 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137212
Page 180 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137213
Page 181 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137214
Page 182 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137215
Page 183 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137216
Page 184 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137217
Page 185 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137218
Page 186 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137219
Page 187 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137220
Page 188 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137221
Page 189 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137222
Page 190 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137223
Page 191 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137224
Page 192 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137225
Page 193 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137226
Page 194 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137227
Page 195 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137228
Page 196 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137229
Page 197 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137230
Page 198 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137231
Page 199 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137232
Page 200 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137233
Page 201 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137234
Page 202 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137235
Page 203 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137236
Page 204 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137237
Page 205 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137238
Page 206 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137239
Page 207 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137240
Page 208 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137241
Page 209 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137242
Page 210 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137243
Page 211 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137244
Page 212 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137245
Page 213 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137246
Page 214 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137247
Page 215 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137248
Page 216 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137249
Page 217 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-09-2021 10:46:24 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137250
Page 218 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
FormFeb-09-2021 10:47:11 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137251
Page 219 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137252
Page 220 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aFeb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137253
Page 221 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aFeb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137254
Page 222 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aFeb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137255
Page 223 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aFeb-10-2021 13:56:33 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Visit conducted via telehealth. No vital signs
done.
Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137256
Page 224 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:47:48 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137257
Page 225 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:47:48 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137258
Page 226 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aFeb-09-2021 10:47:48 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137259
Page 227 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:48:05 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137260
Page 228 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:48:05 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137261
Page 229 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:48:05 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137262
Page 230 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:48:05 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137263
Page 231 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137264
Page 232 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137265
Page 233 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137266
Page 234 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137267
Page 235 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137268
Page 236 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137269
Page 237 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-09-2021 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137270
Page 238 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-09-2021 10:48:37 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137271
Page 239 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-09-2021 10:48:37 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137272
Page 240 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-09-2021 10:48:37 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137273
Page 241 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-09-2021 10:48:37 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137274
Page 242 of 431
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-09-2021 10:48:37 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137275
Page 243 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia Brown Approved Mar-12-2021 11:18:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, 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.
Scott Salmon N/A Mar-11-2021 15:57:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Mar-11-2021 13:57:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Scott Salmon N/A Mar-11-2021 11:56:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137276
Page 244 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Michael Dever Approved Mar-11-2021 06:54:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Scott Salmon N/A Mar-09-2021 09:36:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Mar-05-2021 11:03:09 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Matthew
Stephens N/A Mar-04-2021 15:47:41 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Mar-04-2021 07:13:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137277
Page 245 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Scott Salmon N/A Feb-26-2021 10:03:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia Brown Approved Feb-25-2021 13:41:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, 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.
Scott Salmon N/A Feb-09-2021 10:38:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Jan-29-2021 06:43:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137278
Page 246 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Scott Salmon N/A Jan-26-2021 13:59:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Jan-21-2021 07:08:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Monica Cooper N/A Jan-12-2021 16:18:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Oct-21-2020 12:02:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137279
Page 247 of 431
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, 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.
Matthew
Stephens N/A Oct-06-2020 13:59:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dever Approved Oct-05-2020 12:44:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDever, 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.
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137280
Page 248 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 14:36:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020 14:36:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137281
Page 249 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 14:36:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/17/2020Initial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137282
Page 250 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 14:36:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131190Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 14:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 14:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 14:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020 14:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137283
Page 251 of 431
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 14:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Aug/17/2020Initial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137284
Page 252 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-17-2020 14:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 14:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 14:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137285
Page 253 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020 14:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:MIGRAINE HE
ADACHES
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020 14:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 14:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
MIGRAINE HEADACHESInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 14:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020 14:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137286
Page 254 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b
Date Location User Value Reason
Aug-17-2020 14:37:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:HYPERCHOLES
TEROLEMIA
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020 14:37:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 14:37:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020 14:37:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020 14:37:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137287
Page 255 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-23-2020 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:TARLOV C
YST
Start Date: Dec/UNK/20
19
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
TARLOV CYSTInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Dec/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YESInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137288
Page 256 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
65.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
167.6Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.4Initial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137289
Page 257 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020 14:38:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137290
Page 258 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137291
Page 259 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-17-2020 14:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137292
Page 260 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 15:11:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 15:11:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
49018Initial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137293
Page 261 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 14:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 14:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 17:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 14:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 14:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 17:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BPYWD2Initial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137294
Page 262 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 17:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BPYWD2Initial Entry
5.b
Date Location User Value Reason
Aug-17-2020 17:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BPYWD3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 17:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BPYWD3Initial Entry
5.c
Date Location User Value Reason
Aug-17-2020 17:02:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BPYWD4Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 17:02:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BPYWD4Initial Entry
5.d
Date Location User Value Reason
Aug-17-2020 17:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BNWHHWTranscription Error
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137295
Page 263 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020 17:02:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BNWHHRInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 17:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BNWHHWTranscription Error
Aug-17-2020 17:02:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BNWHHRInitial Entry
5.e
Date Location User Value Reason
Aug-17-2020 17:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BNWHHXTranscription Error
Aug-17-2020 17:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
Sample ID: BNWHHSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 17:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BNWHHXTranscription Error
Aug-17-2020 17:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe mstephens)Data Entry:
BNWHHSInitial Entry
090177e196ae2f5f\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137296
Page 264 of 431
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131190 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 14:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 14:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 17:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 14:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 14:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP60
…[truncated]