125742 S1 M5 CRF c4591001 1013 10131786

Document text

Page 1 of 629
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139863
Page 2 of 629
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 10131786 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
Oct/21/2020
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139864
Page 3 of 629
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131786]
2.Birth Date: /1955
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:
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0139865
Page 4 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10131786 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/21/2020
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139866
Page 5 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139867
Page 6 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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/DeathOct/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139868
Page 7 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
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: 10131786 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:[OBESITY]
Start Date: UNK/UNK/1965
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBSTRUCTIVE SLEEP APNEA]
Start Date: UNK/UNK/1989
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MAJOR DEPRESSIVE DISORDER]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/1999
Ongoing: YES
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139869
Page 8 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/1999
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POSTMENOPAUSAL]
Start Date: UNK/UNK/1999
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE II DIABETES]
Start Date: UNK/UNK/2009
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2009
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139870
Page 9 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LOWER BACK PAIN (LUMBAR)]
Start Date: UNK/UNK/2013
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GOUT]
Start Date: UNK/UNK/2016
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GENERALIZED ANXIETY DISORDER]
Start Date: Jul/UNK/2016
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PERCUTANEOUS CURONARY INTERVENTION]
Start Date: May/1/2018
Ongoing: NO
End Date:
May/1/2018
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139871
Page 10 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[STENT PLACEMENT IN RIGHT CORONARY ARTERY]
Start Date: May/1/2018
Ongoing: NO
End Date:
May/1/2018
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MYOCARDIAL INFARCTION]
Start Date: Jun/23/2019
Ongoing: NO
End Date:
Jun/23/2019
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139872
Page 11 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139873
Page 12 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
2.Weight: [95.9]
3.Unit: kg
4.Height: [167.6]
5.Unit: cm
6.Body Mass Index: [34.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139874
Page 13 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139875
Page 14 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/21/2020
2.Randomization Number: [271797]
3.Randomization Group: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139876
Page 15 of 629
***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, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRC8M4]
5.bSample ID [BRC8M5]
5.cSample ID [BRC8M6]
5.dSample ID [BSHPKR]
5.eSample ID [BSHPKS]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139877
Page 16 of 629
***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, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
Oct/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9TH3]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139878
Page 17 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: Oct/21/2020 11:22
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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139879
Page 18 of 629
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139880
Page 19 of 629
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 10131786 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 Nov/12/2020
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139881
Page 20 of 629
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [35.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139882
Page 21 of 629
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139883
Page 22 of 629
***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, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
Nov/12/2020
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 [BR9TRG]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139884
Page 23 of 629
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: Nov/12/2020 15:03
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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139885
Page 24 of 629
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10131786 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 Dec/10/2020
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139886
Page 25 of 629
***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, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
Dec/10/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRHWPR]
5.bSample ID [BRHWPS]
5.cSample ID [BRHWPT]
5.dSample ID [BS3859]
5.eSample ID [BS385B]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139887
Page 26 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139888
Page 27 of 629
***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, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/8/2021 Comments
2.Date of First Symptom Started: Feb/2/2021 Comments
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/2/2021Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO Comments
4.dSymptoms: CHILLS
Was symptom present? NO Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO Comments
4.hSymptoms: DIARRHEA
Was symptom present? YES Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139889
Page 28 of 629
***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, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO Comments
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139890
Page 29 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139891
Page 30 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139892
Page 31 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139893
Page 32 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139894
Page 33 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139895
Page 34 of 629
***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: 10131786 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 Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139896
Page 35 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139897
Page 36 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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?NO
3.Toxicity Grade: 3
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139898
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***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139899
Page 38 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139900
Page 39 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139901
Page 40 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139902
Page 41 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139903
Page 42 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139904
Page 43 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139905
Page 44 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139906
Page 45 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139907
Page 46 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139908
Page 47 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139909
Page 48 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139910
Page 49 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139911
Page 50 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139912
Page 51 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139913
Page 52 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139914
Page 53 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139915
Page 54 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139916
Page 55 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139917
Page 56 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139918
Page 57 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139919
Page 58 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139920
Page 59 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139921
Page 60 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139922
Page 61 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139923
Page 62 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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/26/2021
2.Date of First Symptom Started: Jan/30/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/26/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139924
Page 63 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139925
Page 64 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139926
Page 65 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139927
Page 66 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[COLLECTED AT SITE VISIT]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139928
Page 67 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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:
Feb/26/2021
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 [BR64JC]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139929
Page 68 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
[2]
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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139930
Page 69 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139931
Page 70 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139932
Page 71 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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?NO
3.Toxicity Grade: 2
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139933
Page 72 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139934
Page 73 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139935
Page 74 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
 1.CLINICA
L CHEMIS
TRY ORLANDO REGIONAL MEDICA
L CENTER, 1414 KUHL AVE. OR
LANDO, FL 32806 Feb/26
/2021 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329  C Reactive Pr
otein_PX329 1.0 
30  Alanine Amin
otransferase_
PX30 12 
28  Aspartate Am
inotransferase
_PX28 15 
35  Alkaline Phos
phatase_PX3
5 70 
21  Bilirubin_PX
21 0.3 
47  Blood Urea N
itrogen_PX47
 17 
48  Creatinine_P
X48 1.1
3 Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139936
Page 75 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: Feb/26/2021
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: [12]
Not Done:
LNMT Low
[7]
High
[52]
Unit
U/L
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139937
Page 76 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [15]
Not Done:
LNMT Low
[13]
High
[39]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [70]
Not Done:
LNMT Low
[34]
High
[104]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.3]
High
[1.0]
Unit
mg/dL
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139938
Page 77 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [17]
Not Done:
LNMT Low
[7]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.13]
Not Done:
LNMT Low
[0.60]
High
[1.20]
Unit
mg/dL
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139939
Page 78 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY ORLANDO REGIONAL MEDICAL
CENTER, 1414 KUHL AVE. ORLAN
DO, FL 32806 Feb/26/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1  Hemoglo
bin_PX1 11.
8 
2  Hematocr
it_PX2 39.
4 
3  Erythrocy
tes_PX3 4.3
9 
5  Platelets_
PX5 210
 
7  Leukocyt
es_PX7 6.1 
608  Neutrophi
ls_PX608
 3.4 
609  Eosinophi
ls_PX609
 0.2 
612  Monocyte
s_PX612 0.4 
610  Basophils
_PX610 0.0 
611  Lymphoc
ytes_PX6
11 2.1 Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139940
Page 79 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: Feb/26/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.8]
Not Done:
LNMT Low
[11.4]
High
[14.7]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [39.4]
Not Done:
LNMT Low
[34.3]
High
[45.5]
Unit
%
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139941
Page 80 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.39]
Not Done:
LNMT Low
[3.75]
High
[5.00]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [210]
Not Done:
LNMT Low
[139]
High
[361]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.1]
Not Done:
LNMT Low
[4.4]
High
[10.5]
Unit
10^3/uL
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139942
Page 81 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [3.4]
Not Done:
LNMT Low
[1.5]
High
[7.5]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.5]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.4]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139943
Page 82 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.1]
Not Done:
LNMT Low
[1.0]
High
[4.8]
Unit
10^3/uL
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139944
Page 83 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1.Feb/26/2021 Record Identifier: Systolic: Diastolic:
1  128  82 Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139945
Page 84 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/26/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [128]
Diastolic: [82]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [61]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139946
Page 85 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1.Feb/26/2021 Record Identifier: Oxygen Saturation
1  99.0 Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139947
Page 86 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Feb/26/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139948
Page 87 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139949
Page 88 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139950
Page 89 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139951
Page 90 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139952
Page 91 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139953
Page 92 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/26/2021Form: 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139954
Page 93 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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/26/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139955
Page 94 of 629
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: 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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139956
Page 95 of 629
***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: 10131786 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:
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139957
Page 96 of 629
***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: 10131786 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 [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139958
Page 97 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  SYNCOPAL EPISO
DE Jan/30/2021 UNK:
UNK NO
End Date Time:
Feb/1/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  COVID-19 PNEUM
ONIA Feb/2/2021 UNK:
UNK NO
End Date Time:
Feb/6/2021 UNK:UNK
 Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139959
Page 98 of 629
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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)[SYNCOPAL EPISODE]
4.Start Date Time: Jan/30/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/1/2021 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139960
Page 99 of 629
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021101810]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139961
Page 100 of 629
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[COVID-19 PNEUMONIA]
4.Start Date Time: Feb/2/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/6/2021 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139962
Page 101 of 629
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021132689]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139963
Page 102 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139964
Page 103 of 629
***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: 10131786 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[ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139965
Page 104 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
 1. DELETED           Repeating
Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139966
Page 105 of 629
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
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: //
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139967
Page 106 of 629
***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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139968
Page 107 of 629
***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: 10131786 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?
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139969
Page 108 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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***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: 10131786 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?
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FDA-CBER-2021-5683-0139971
Page 110 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139972
Page 111 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139973
Page 112 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139974
Page 113 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139975
Page 114 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139976
Page 115 of 629
***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: 10131786 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:
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139977
Page 116 of 629
***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: 10131786 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:
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139978
Page 117 of 629
***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: 10131786 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?
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139979
Page 118 of 629
***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: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139980
Page 119 of 629
***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: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139981
Page 120 of 629
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
:Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139982
Page 121 of 629
***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: 10131786 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/18/2021
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139983
Page 122 of 629
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139984
Page 123 of 629
***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: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139985
Page 124 of 629
***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: 10131786 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/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139986
Page 125 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139987
Page 126 of 629
***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: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139988
Page 127 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139989
Page 128 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139990
Page 129 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139991
Page 130 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139992
Page 131 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139993
Page 132 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 10131786 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:
Jan/25/2021
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 [BRBR30]
5.bSample ID [BRBR31]
5.cSample ID [BRBR32]
5.dSample ID [BSLRHM]
5.eSample ID [BSLRHN]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139994
Page 133 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 10131786 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:
Jan/25/2021
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 [BRBRPM]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139995
Page 134 of 629
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139996
Page 135 of 629
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139997
Page 136 of 629
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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:
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139998
Page 137 of 629
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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 [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0139999
Page 138 of 629
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10131786 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?
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140000
Page 139 of 629
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140001
Page 140 of 629
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140002
Page 141 of 629
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140003
Page 142 of 629
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140004
Page 143 of 629
***Confidential***
 
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Visit: V105_MONTH18 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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140005
Page 144 of 629
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140006
Page 145 of 629
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140007
Page 146 of 629
***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: 10131786 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 Dec/10/2020
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140008
Page 147 of 629
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140009
Page 148 of 629
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140010
Page 149 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-21-2020 15:18:25 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140011
Page 150 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140012
Page 151 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140013
Page 152 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140014
Page 153 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Oct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140015
Page 154 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Oct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140016
Page 155 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Oct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140017
Page 156 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140018
Page 157 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140019
Page 158 of 629
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aOct-21-2020 15:23:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140020
Page 159 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140021
Page 160 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140022
Page 161 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140023
Page 162 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140024
Page 163 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140025
Page 164 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140026
Page 165 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140027
Page 166 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140028
Page 167 of 629
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aNov-12-2020 16:24:06 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140029
Page 168 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
FormMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140030
Page 169 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
1Mar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140031
Page 170 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
2Mar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140032
Page 171 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
3Mar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140033
Page 172 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.aMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.aMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140034
Page 173 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.bMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.bMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140035
Page 174 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.cMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.cMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140036
Page 175 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.dMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.dMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140037
Page 176 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.eMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.eMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140038
Page 177 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4 fMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4 fMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140039
Page 178 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.gMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.gMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140040
Page 179 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4 hMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4 hMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140041
Page 180 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Answered Queries
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4.iMar-03-2021 15:54:43 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)
4.iMar-02-2021 09:32:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140042
Page 181 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140043
Page 182 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140044
Page 183 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140045
Page 184 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140046
Page 185 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140047
Page 186 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140048
Page 187 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140049
Page 188 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140050
Page 189 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140051
Page 190 of 629
***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, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Feb-19-2021 14:31:40 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140052
Page 191 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-09-2021 16:17:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140053
Page 192 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-09-2021 16:17:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140054
Page 193 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-09-2021 16:17:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140055
Page 194 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-09-2021 16:17:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140056
Page 195 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-09-2021 16:17:23 (UTC-05:00) Eastern
Time (US & Canada)Matthew
Stephens
(pfe mstephens)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140057
Page 196 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-02-2021 09:26:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140058
Page 197 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-02-2021 09:26:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140059
Page 198 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-02-2021 09:26:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140060
Page 199 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-02-2021 09:26:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140061
Page 200 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-02-2021 09:26:21 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140062
Page 201 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140063
Page 202 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140064
Page 203 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140065
Page 204 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140066
Page 205 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140067
Page 206 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140068
Page 207 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Feb-19-2021 14:34:28 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140069
Page 208 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:35:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140070
Page 209 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-19-2021 14:35:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140071
Page 210 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-19-2021 14:35:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140072
Page 211 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-19-2021 14:35:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140073
Page 212 of 629
***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: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-19-2021 14:35:35 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Not Applicable
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140074
Page 213 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140075
Page 214 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140076
Page 215 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140077
Page 216 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140078
Page 217 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140079
Page 218 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140080
Page 219 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140081
Page 220 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140082
Page 221 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140083
Page 222 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140084
Page 223 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140085
Page 224 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140086
Page 225 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140087
Page 226 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140088
Page 227 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140089
Page 228 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140090
Page 229 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140091
Page 230 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140092
Page 231 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140093
Page 232 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140094
Page 233 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140095
Page 234 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140096
Page 235 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140097
Page 236 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140098
Page 237 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140099
Page 238 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140100
Page 239 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140101
Page 240 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140102
Page 241 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140103
Page 242 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140104
Page 243 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140105
Page 244 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140106
Page 245 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:07 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)Televisit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140107
Page 246 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140108
Page 247 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140109
Page 248 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140110
Page 249 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140111
Page 250 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140112
Page 251 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140113
Page 252 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140114
Page 253 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140115
Page 254 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140116
Page 255 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140117
Page 256 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140118
Page 257 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140119
Page 258 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140120
Page 259 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140121
Page 260 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140122
Page 261 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140123
Page 262 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140124
Page 263 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140125
Page 264 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140126
Page 265 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140127
Page 266 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.dFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140128
Page 267 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140129
Page 268 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140130
Page 269 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140131
Page 270 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.eFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140132
Page 271 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140133
Page 272 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140134
Page 273 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140135
Page 274 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 fFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140136
Page 275 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140137
Page 276 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140138
Page 277 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140139
Page 278 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.gFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140140
Page 279 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140141
Page 280 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140142
Page 281 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140143
Page 282 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5 hFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140144
Page 283 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140145
Page 284 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140146
Page 285 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140147
Page 286 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.iFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140148
Page 287 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140149
Page 288 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140150
Page 289 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140151
Page 290 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.jFeb-19-2021 14:36:39 (UTC-05:00) Eastern
Time (US & Canada)Scott Salmon
(pfe.ssalmon)tele-visit
Not Done
090177e196ae2f62\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0140152
Page 291 of 629
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/08/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131786 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
B
…[truncated]