125742 S1 M5 CRF c4591001 1098 10981024

Document text

Page 1 of 885
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972902
Page 2 of 885
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972903
Page 3 of 885
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [10981024]
2.Birth Date: 1952
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0972904
Page 4 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972905
Page 5 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972906
Page 6 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972907
Page 7 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Feb/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: Aug/3/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 Diabetes]
Start Date: UNK/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cronary Artery Disease]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972908
Page 8 of 885
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COPD]
Start Date: UNK/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[A-Fib]
Start Date: UNK/UNK/2016
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1980
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHF]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972909
Page 9 of 885
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myocardial Infarction]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972910
Page 10 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [191.0]
3.Unit: LB
4.Height: [67.2]
5.Unit: in
6.Body Mass Index: [29.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972911
Page 11 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972912
Page 12 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [235390]
3.Randomization Group: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972913
Page 13 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BN5XBN]
5.bSample ID [BN5XBP]
5.cSample ID [BN5XBR]
5.dSample ID [BL9YN6]
5.eSample ID [BL9YN7]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972914
Page 14 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BN5XCD]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972915
Page 15 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 10:41
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972916
Page 16 of 885
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972917
Page 17 of 885
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972918
Page 18 of 885
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972919
Page 19 of 885
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BN666V]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972920
Page 20 of 885
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 09:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972921
Page 21 of 885
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972922
Page 22 of 885
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSMSN9]
5.bSample ID [BSMSNB]
5.cSample ID [BR8GX4]
5.dSample ID [BR8GX5]
5.eSample ID [BR8GX6]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972923
Page 23 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/4/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972924
Page 24 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.          Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972925
Page 25 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972926
Page 26 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972927
Page 27 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972928
Page 28 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972929
Page 29 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972930
Page 30 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972931
Page 31 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972932
Page 32 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972933
Page 33 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972934
Page 34 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972935
Page 35 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972936
Page 36 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972937
Page 37 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972938
Page 38 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972939
Page 39 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972940
Page 40 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972941
Page 41 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972942
Page 42 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972943
Page 43 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/04/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972944
Page 44 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972945
Page 45 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/7/2020
2.Date of First Symptom Started: Oct/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/9/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972946
Page 46 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972947
Page 47 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/7/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972948
Page 48 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/7/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT unknown] Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972949
Page 49 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [CV47551]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972950
Page 50 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[According to the protocol, its not needed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972951
Page 51 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972952
Page 52 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972953
Page 53 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972954
Page 54 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Community Acquired Pneumonia]
Date of Diagnosis:
Oct/7/2020
3.Toxicity Grade: 1
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972955
Page 55 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972956
Page 56 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972957
Page 57 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.CLINICAL CH
EMISTRY MDMC  Oct/7/202
0 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
329  C Reactive Protein_P
X329 <5 
30  Alanine Aminotransf
erase_PX30  
28  Aspartate Aminotran
sferase_PX28  
35  Alkaline Phosphatas
e_PX35 [ ] 
21  Bilirubin_PX21  [ ] 
47  Blood Urea Nitrogen
_PX47 32 
48  Creatinine_PX48  1.14 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972958
Page 58 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
 2.CLINICAL CH
EMISTRY MDMC
Lab Oct/9/202
0 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
329  C Reactive Protein_P
X329 [ ] 
30  Alanine Aminotransf
erase_PX30 51 
28  Aspartate Aminotran
sferase_PX28 32 
35  Alkaline Phosphatas
e_PX35 82 
21  Bilirubin_PX21  0.6 
47  Blood Urea Nitrogen
_PX47 33 
48  Creatinine_PX48  1.10 Repeating
Pages
 3.CLINICAL CH
EMISTRY MDMC
Lab Oct/8/202
0 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
329  C Reactive Protein_P
X329 [ ] 
30  Alanine Aminotransf
erase_PX30 58 
28  Aspartate Aminotran
sferase_PX28 38 
35  Alkaline Phosphatas
e_PX35 86 
21  Bilirubin_PX21  0.3 
47  Blood Urea Nitrogen
_PX47 29 
48  Creatinine_PX48  1.00 Repeating
Pages
 4.CLINICAL CH
EMISTRY MDMC  Oct/4/202
0 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
329  C Reactive Protein_P
X329 [ ] 
30  Alanine Aminotransf 19 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972959
Page 59 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
Sponsor-Define
d IdentifierTest:Res
ult:
erase_PX30 
28  Aspartate Aminotran
sferase_PX28 34 
35  Alkaline Phosphatas
e_PX35 93 
21  Bilirubin_PX21  0.6 
47  Blood Urea Nitrogen
_PX47 21 
48  Creatinine_PX48  1.15 
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972960
Page 60 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [MDMC]
3.Collection Date: Oct/7/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [<5]
Not Done:
LNMT Low
[n/a]
High
[10]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972961
Page 61 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972962
Page 62 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [32]
Not Done:
LNMT Low
[10]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.14]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972963
Page 63 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [MDMC Lab]
3.Collection Date: Oct/9/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [51]
Not Done:
LNMT Low
[n/a]
High
[50]
Unit
U/L
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972964
Page 64 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [32]
Not Done:
LNMT Low
[8]
High
[42]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [82]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.0]
High
[1.4]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972965
Page 65 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [33]
Not Done:
LNMT Low
[10]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.10]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972966
Page 66 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [MDMC Lab]
3.Collection Date: Oct/8/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [58]
Not Done:
LNMT Low
[n/a]
High
[50]
Unit
U/L
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972967
Page 67 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [38]
Not Done:
LNMT Low
[8]
High
[42]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [86]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[1.4]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972968
Page 68 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [29]
Not Done:
LNMT Low
[10]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.00]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972969
Page 69 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [MDMC]
3.Collection Date: Oct/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [19]
Not Done:
LNMT Low
[n/a]
High
[50]
Unit
U/L
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972970
Page 70 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [34]
Not Done:
LNMT Low
[8]
High
[42]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [93]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.6]
Not Done:
LNMT Low
[0.0]
High
[1.4]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972971
Page 71 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [21]
Not Done:
LNMT Low
[10]
High
[25]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.15]
Not Done:
LNMT Low
[0.70]
High
[1.40]
Unit
mg/dL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972972
Page 72 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.HEMATOLO
GY MDMC Lab  Oct/9/202
0 BLOOD Sponsor-Define
d IdentifierTest:Resu
lt:
1  Hemoglobin_
PX1 15.5 
2  Hematocrit_P
X2 49.8 
3  Erythrocytes_
PX3 5.22 
5  Platelets_PX
5 230 
7  Leukocytes_
PX7 8.7 
608  Neutrophils_
PX608 5.8 
609  Eosinophils_
PX609 0.3 
612  Monocytes_P
X612 0.9 
610  Basophils_P
X610 0.1 
611  Lymphocytes
_PX611 1.5 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972973
Page 73 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 2.HEMATOLO
GY MDMC lab  Oct/8/202
0 BLOOD Sponsor-Define
d IdentifierTest:Resu
lt:
1  Hemoglobin_
PX1 13.8 
2  Hematocrit_P
X2 43.8 
3  Erythrocytes_
PX3 4.61 
5  Platelets_PX
5 201 
7  Leukocytes_
PX7 10.4 
608  Neutrophils_
PX608 7.1 
609  Eosinophils_
PX609 0.1 
612  Monocytes_P
X612 1.1 
610  Basophils_P
X610 0.1 
611  Lymphocytes
_PX611 1.9 Repeating
Pages
 3.HEMATOLO
GY MDMC Lab  Oct/7/202
0 BLOOD Sponsor-Define
d IdentifierTest:Resu
lt:
1  Hemoglobin_
PX1 12.5 
2  Hematocrit_P
X2 39.3 
3  Erythrocytes_
PX3 4.14 
5  Platelets_PX
5 205 
7  Leukocytes_
PX7 10.7 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972974
Page 74 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
Sponsor-Define
d IdentifierTest:Resu
lt:
608  Neutrophils_
PX608 9.2 
609  Eosinophils_
PX609 0.0 
612  Monocytes_P
X612 0.6 
610  Basophils_P
X610 0.0 
611  Lymphocytes
_PX611 0.8 
 4.HEMATOLO
GY MDMC  Oct/4/202
0 BLOOD Sponsor-Define
d IdentifierTest:Resu
lt:
1  Hemoglobin_
PX1 13.5 
2  Hematocrit_P
X2 4.21 
3  Erythrocytes_
PX3 4.52 
5  Platelets_PX
5 205 
7  Leukocytes_
PX7 8.9 
608  Neutrophils_
PX608 5.9 
609  Eosinophils_
PX609 0.2 
612  Monocytes_P
X612 0.8 
610  Basophils_P
X610 0.1 
611  Lymphocytes
_PX611 1.8 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972975
Page 75 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [MDMC Lab]
3.Collection Date: Oct/9/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.5]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [49.8]
Not Done:
LNMT Low
[40.2]
High
[52.0]
Unit
%
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972976
Page 76 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [5.22]
Not Done:
LNMT Low
[4.50]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [230]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [8.7]
Not Done:
LNMT Low
[3.8]
High
[10.6]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972977
Page 77 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.8]
Not Done:
LNMT Low
[1.4]
High
[7.3]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.3]
Not Done:
LNMT Low
[n/a]
High
[0.6]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.9]
Not Done:
LNMT Low
[0.1]
High
[1.1]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972978
Page 78 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[n/a]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.5]
Not Done:
LNMT Low
[0.9]
High
[4.8]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972979
Page 79 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [MDMC lab]
3.Collection Date: Oct/8/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.8]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43.8]
Not Done:
LNMT Low
[40.2]
High
[52]
Unit
%
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972980
Page 80 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.61]
Not Done:
LNMT Low
[4.50]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [201]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [10.4]
Not Done:
LNMT Low
[3.8]
High
[10.6]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972981
Page 81 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [7.1]
Not Done:
LNMT Low
[1.4]
High
[7.3]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.1]
Not Done:
LNMT Low
[n/a]
High
[0.6]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [1.1]
Not Done:
LNMT Low
[0.1]
High
[1.1]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972982
Page 82 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[n/a]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.9]
Not Done:
LNMT Low
[0.9]
High
[4.8]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972983
Page 83 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [MDMC Lab]
3.Collection Date: Oct/7/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.5]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [39.3]
Not Done:
LNMT Low
[40.2]
High
[52.0]
Unit
%
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972984
Page 84 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.14]
Not Done:
LNMT Low
[4.50]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [205]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [10.7]
Not Done:
LNMT Low
[3.8]
High
[10.6]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972985
Page 85 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [9.2]
Not Done:
LNMT Low
[1.4]
High
[7.3]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[n/a]
High
[0.6]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.6]
Not Done:
LNMT Low
[0.1]
High
[1.1]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972986
Page 86 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[n/a]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.8]
Not Done:
LNMT Low
[0.9]
High
[4.8]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972987
Page 87 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [MDMC]
3.Collection Date: Oct/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.5]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [4.21]
Not Done:
LNMT Low
[40.2]
High
[52.0]
Unit
%
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972988
Page 88 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.52]
Not Done:
LNMT Low
[4.50]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [205]
Not Done:
LNMT Low
[130]
High
[400]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [8.9]
Not Done:
LNMT Low
[3.8]
High
[10.6]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972989
Page 89 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.9]
Not Done:
LNMT Low
[1.4]
High
[7.3]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.2]
Not Done:
LNMT Low
[n/a]
High
[0.6]
Unit
10^3/uL
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.8]
Not Done:
LNMT Low
[0.1]
High
[1.1]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972990
Page 90 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[n/a]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.8]
Not Done:
LNMT Low
[0.9]
High
[4.8]
Unit
10^3/uL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972991
Page 91 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Oct/9/2020 Record Identifier: Systolic: Diastolic:
1  132  75 Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972992
Page 92 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 2. Oct/8/2020 Record Identifier: Systolic: Diastolic:
1  163  84 Repeating Pages
 3. Oct/7/2020 Record Identifier: Systolic: Diastolic:
1  142  89 Repeating Pages
 4. Oct/4/2020 Record Identifier: Systolic: Diastolic:
1  162  98 Repeating Pages
 5. DELETED Oct/4/2020 Record Identifier: Systolic: Diastolic:
1  158  87 Repeating Pages
 6. DELETED Oct/4/2020 Record Identifier: Systolic: Diastolic:
1  159  107 Repeating Pages
 7. Oct/5/2020 Record Identifier: Systolic: Diastolic:
1  141  87 Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972993
Page 93 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [132]
Diastolic: [75]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [79]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972994
Page 94 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [163]
Diastolic: [84]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [63]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972995
Page 95 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [142]
Diastolic: [89]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [63]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972996
Page 96 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [162]
Diastolic: [98]
Respiratory Rate in
respirations/minute:[21]
Heart Rate in beats/minute: [64]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972997
Page 97 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [158]
Diastolic: [87]
Respiratory Rate in
respirations/minute:[21]
Heart Rate in beats/minute: [59]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972998
Page 98 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [159]
Diastolic: [107]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [64]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0972999
Page 99 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [141]
Diastolic: [87]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [69]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973000
Page 100 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Oct/9/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973001
Page 101 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 2. Oct/8/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
 3. Oct/4/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
 4. DELETED Oct/4/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 5. DELETED Oct/4/2020 Record Identifier: Oxygen Saturation
1  95.0 Repeating Pages
 6. Oct/5/2020 Record Identifier: Oxygen Saturation
1  100.0 Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973002
Page 102 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973003
Page 103 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973004
Page 104 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973005
Page 105 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973006
Page 106 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/4/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973007
Page 107 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973008
Page 108 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973009
Page 109 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973010
Page 110 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973011
Page 111 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973012
Page 112 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessmen
tLocation of Assessmen
tImaging Metho
dOverall Assessment Form Instance
 1.Oct/7/2020  CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
New bilateral basilar infiltrates
.
 Repeating Pages
 2.Oct/8/2020  CHEST  OTHER
If other, specify
:
echo
 NORMAL  Repeating Pages
 3.Nov/4/2020  CHEST  X-RAY  NORMAL  Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973013
Page 113 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/7/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[New bilateral basilar infiltrates.]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973014
Page 114 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Oct/8/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: OTHER
If other, specify:
[echo]
4.Assessment: NORMAL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973015
Page 115 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/4/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973016
Page 116 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973017
Page 117 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/5/2021
2.Date of First Symptom Started: Jan/2/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/6/2021
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? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973018
Page 118 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Runny Nose]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973019
Page 119 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973020
Page 120 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973021
Page 121 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
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 [CV60740]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973022
Page 122 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[According to the protocol, it is not needed to be done.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973023
Page 123 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973024
Page 124 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973025
Page 125 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973026
Page 126 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973027
Page 127 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973028
Page 128 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973029
Page 129 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973030
Page 130 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973031
Page 131 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973032
Page 132 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973033
Page 133 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973034
Page 134 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973035
Page 135 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973036
Page 136 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973037
Page 137 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973038
Page 138 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973039
Page 139 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973040
Page 140 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973041
Page 141 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973042
Page 142 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973043
Page 143 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973044
Page 144 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973045
Page 145 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973046
Page 146 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973047
Page 147 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973048
Page 148 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973049
Page 149 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973050
Page 150 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Jan/05/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973051
Page 151 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973052
Page 152 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSMSWM]
5.bSample ID [BSMSWN]
5.cSample ID [BR8H76]
5.dSample ID [BR8H77]
5.eSample ID [BR8H78]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973053
Page 153 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - 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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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_C1
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973054
Page 154 of 885
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - 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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BR30CC]
5.bSample ID [BR30CD]
5.cSample ID [BR30CF]
5.dSample ID [BPMH31]
5.eSample ID [BPMH32]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973055
Page 155 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973056
Page 156 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973057
Page 157 of 885
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973058
Page 158 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973059
Page 159 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973060
Page 160 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973061
Page 161 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  ChestPain  Oct/7/2020 1
9:30 NO
End Date Time:
Oct/9/2020 12:00
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  Fever  Oct/5/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  Cough  Oct/5/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  Chills  Oct/5/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 5. ADVERSE
EVENT 5  Shortness of Breath  Oct/1/2020
UNK:UNK NO
End Date Time:
Oct/7/2020 UNK:
UNK
 Repeating
Pages
 6. ADVERSE
EVENT 6  Community Acquired Pneumo
nia Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 7. ADVERSE
EVENT 7  Dizziness  Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/7/2020 UNK:
UNKRepeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973062
Page 162 of 885
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 
 8. ADVERSE
EVENT 8  fall  Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/7/2020 UNK:
UNK
 Repeating
Pages
 9. ADVERSE
EVENT 9  COPD with acute exacerbation  Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 10. ADVERSE
EVENT 10  Diastolic Congestive Heart Fail
ure with acute exacerbation Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 11. ADVERSE
EVENT 11  Unstable Angina Pectoris Mod
erate Oct/4/2020
UNK:UNK NO
End Date Time:
Oct/5/2020 UNK:
UNK
 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973063
Page 163 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[ChestPain]
4.Start Date Time: Oct/7/2020 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973064
Page 164 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
[Community Acquired Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020397526]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973065
Page 165 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever]
4.Start Date Time: Oct/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[n/a]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973066
Page 166 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973067
Page 167 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cough]
4.Start Date Time: Oct/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[n/a]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973068
Page 168 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973069
Page 169 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chills]
4.Start Date Time: Oct/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[n/a]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973070
Page 170 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973071
Page 171 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Shortness of Breath]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pneomonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973072
Page 172 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973073
Page 173 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Community Acquired Pneumonia]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973074
Page 174 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
[uknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
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[2020397526]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973075
Page 175 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Community Acquired Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973076
Page 176 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973077
Page 177 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Community Acquired Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973078
Page 178 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973079
Page 179 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[COPD with acute exacerbation]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[COPD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973080
Page 180 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973081
Page 181 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diastolic Congestive Heart Failure with acute exacerbation]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973082
Page 182 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973083
Page 183 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Unstable Angina Pectoris Moderate]
4.Start Date Time: Oct/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/5/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment: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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973084
Page 184 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973085
Page 185 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973086
Page 186 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973087
Page 187 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  Flu vaccine  Sep/9/20
20 Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973088
Page 188 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Flu vaccine]
5.Date: Sep/9/2020
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applica
ble Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973090
Page 190 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973091
Page 191 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973092
Page 192 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973093
Page 193 of 885
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973094
Page 194 of 885
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973095
Page 195 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973096
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***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973097
Page 197 of 885
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973098
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***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973099
Page 199 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973100
Page 200 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973101
Page 201 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973102
Page 202 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973103
Page 203 of 885
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973104
Page 204 of 885
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973105
Page 205 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973106
Page 206 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/3/2021
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973107
Page 207 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973108
Page 208 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973109
Page 209 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Blood draw was done 5 days ago for the convalascent visit. According to the
protocol, it s not needed to be done again.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973110
Page 210 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BR30FC]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973111
Page 211 of 885
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/3/2021 08:48
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
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973112
Page 212 of 885
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973113
Page 213 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973114
Page 214 of 885
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973115
Page 215 of 885
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973116
Page 216 of 885
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973117
Page 217 of 885
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973118
Page 218 of 885
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973119
Page 219 of 885
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973120
Page 220 of 885
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973121
Page 221 of 885
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973122
Page 222 of 885
***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973123
Page 223 of 885
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973124
Page 224 of 885
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Salma Saiger  Approved Mar-04-2021 13:08:50 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SalmaSaiger, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0973125
Page 225 of 885
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormAug-26-2020 13:31:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973126
Page 226 of 885
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Aug-26-2020 14:32:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973127
Page 227 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Nov-03-2020 07:38:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973128
Page 228 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-28-2020 14:57:38 (UTC-06:00) Central
Time (US & Canada)
FormOct-15-2020 08:08:12 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-13-2020 16:09:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973129
Page 229 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
1Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
1Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973130
Page 230 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
2Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
2Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973131
Page 231 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
3Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
3Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973132
Page 232 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
4Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
4Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973133
Page 233 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
5Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
5Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973134
Page 234 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
6Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
6Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973135
Page 235 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
7Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
7Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973136
Page 236 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
8Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
8Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
8Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973137
Page 237 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
9Oct-28-2020 14:57:38 (UTC-06:00) Central Time
(US & Canada)
9Oct-15-2020 08:08:12 (UTC-06:00) Central Time
(US & Canada)Not Done
9Oct-13-2020 16:09:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973138
Page 238 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormNov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973139
Page 239 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973140
Page 240 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973141
Page 241 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973142
Page 242 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973143
Page 243 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973144
Page 244 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Nov-16-2020 09:00:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973145
Page 245 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormNov-16-2020 09:01:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973146
Page 246 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Nov-16-2020 09:01:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973147
Page 247 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Nov-16-2020 09:01:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973148
Page 248 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Nov-16-2020 09:01:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973149
Page 249 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Nov-16-2020 09:01:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973150
Page 250 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormNov-16-2020 09:01:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973151
Page 251 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Nov-16-2020 09:01:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973152
Page 252 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Nov-16-2020 09:01:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973153
Page 253 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Nov-16-2020 09:01:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973154
Page 254 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormNov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973155
Page 255 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973156
Page 256 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973157
Page 257 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973158
Page 258 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973159
Page 259 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973160
Page 260 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic
Subject No: 10981024 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Nov-16-2020 09:01:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30f0\Final\Final On: 01-Apr-2021 04:20 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0973161
Page 261 of 885
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 
…[truncated]