Document text
Page 1 of 565
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980897
Page 2 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/18/2020
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980898
Page 3 of 565
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161253]
2.Birth Date: /1958
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:
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980899
Page 4 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980900
Page 5 of 565
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980901
Page 6 of 565
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980902
Page 7 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ERECTILE DYSFUNCTION]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asymptomatic Tachycardia]
Start Date: Sep/18/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prostate Cancer]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980903
Page 8 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prostatectomy]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Eye Radial Keratotomy]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1981
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980904
Page 9 of 565
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980905
Page 10 of 565
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [253.1]
3.Unit: LB
4.Height: [72.75]
5.Unit: in
6.Body Mass Index: [33.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980906
Page 11 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [262160]
3.Randomization Group: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980907
Page 12 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BPTYK5]
5.bSample ID [BPTYK6]
5.cSample ID [BLBFPZ]
5.dSample ID [BLBFR0]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980908
Page 13 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP41BN]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980909
Page 14 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/18/2020 17:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980910
Page 15 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980911
Page 16 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980912
Page 17 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980913
Page 18 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP418K]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980914
Page 19 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980915
Page 20 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980916
Page 21 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [BR633X]
5.bSample ID [BR633Y]
5.cSample ID [BSN5ZX]
5.dSample ID [BSN5ZY]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980917
Page 22 of 565
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980918
Page 23 of 565
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980919
Page 24 of 565
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980920
Page 25 of 565
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980921
Page 26 of 565
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980922
Page 27 of 565
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980923
Page 28 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980924
Page 29 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/28/2020
2.Date of First Symptom Started: Sep/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/6/2020
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? YES
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
Symptoms - Other
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980925
Page 30 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.Symptoms - Other Text: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980926
Page 31 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/26/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980927
Page 32 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/26/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [The trade name of swab was not in the medical report. CRC called and was given
name below.]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980928
Page 33 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Swab Collected In Clinic] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980929
Page 34 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BP4158]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980930
Page 35 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: YES
Number of Visits or Contacts:
[1]
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980931
Page 36 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980932
Page 37 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980933
Page 38 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Covid-19]
Date of Diagnosis:
Sep/26/2020
3.Toxicity Grade: 3
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980934
Page 39 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980935
Page 40 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980936
Page 41 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980937
Page 42 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980938
Page 43 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980939
Page 44 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980940
Page 45 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980941
Page 46 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980942
Page 47 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980943
Page 48 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980944
Page 49 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980945
Page 50 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980946
Page 51 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980947
Page 52 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980948
Page 53 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Sep/28/2020 Record Identifier: Systolic: Diastolic:
1 118 84 Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980949
Page 54 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [118]
Diastolic: [84]
Respiratory Rate in
respirations/minute:[28]
Heart Rate in beats/minute: [137]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980950
Page 55 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Sep/28/2020 Record Identifier: Oxygen Saturation
1 96.0 Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980951
Page 56 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980952
Page 57 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980953
Page 58 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980954
Page 59 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980955
Page 60 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980956
Page 61 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980957
Page 62 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980958
Page 63 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980959
Page 64 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/27/2020
2.Date of First Symptom Started: Oct/25/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/12/2020
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
Symptoms - Other
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980960
Page 65 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.aSymptoms - Other Text: [Body Aches]
5.bSymptoms - Other Text: [Headache, Initiated with cough]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980961
Page 66 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980962
Page 67 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980963
Page 68 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Swab Collected In Clinic] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980964
Page 69 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BR62TC]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980965
Page 70 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980966
Page 71 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980967
Page 72 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980968
Page 73 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980969
Page 74 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980970
Page 75 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980971
Page 76 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980972
Page 77 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980973
Page 78 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980974
Page 79 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980975
Page 80 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980976
Page 81 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980977
Page 82 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980978
Page 83 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980979
Page 84 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980980
Page 85 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980981
Page 86 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980982
Page 87 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980983
Page 88 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Oct/27/2020 Record Identifier: Systolic: Diastolic:
1 125 91 Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980984
Page 89 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125]
Diastolic: [91]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [108]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980985
Page 90 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Oct/27/2020 Record Identifier: Oxygen Saturation
1 98.0 Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980986
Page 91 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980987
Page 92 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980988
Page 93 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980989
Page 94 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980990
Page 95 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980991
Page 96 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980992
Page 97 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980993
Page 98 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980994
Page 99 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPMF3C]
5.bSample ID [BPMF3D]
5.cSample ID [BPTYXM]
5.dSample ID [BPTYXN]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980995
Page 100 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980996
Page 101 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980997
Page 102 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980998
Page 103 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980999
Page 104 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981000
Page 105 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981001
Page 106 of 565
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981002
Page 107 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981003
Page 108 of 565
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medicatio
nStart DateForm Instanc
e
1.1 VACCINATIONS NO Moderna COVID 19
vaccine Jan/UNK/2
021 Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981004
Page 109 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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).[Moderna COVID 19 vaccine]
5.Date: Jan/UNK/2021
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981005
Page 110 of 565
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
1. DELETED Repeating
Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981006
Page 111 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981007
Page 112 of 565
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981008
Page 113 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981009
Page 114 of 565
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981010
Page 115 of 565
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981011
Page 116 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/28/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Patient was symptomatic and tested positive for COVID-19 between Vaccine 1 and
Vaccine 2]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981012
Page 117 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981013
Page 118 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981014
Page 119 of 565
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981015
Page 120 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981016
Page 121 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981017
Page 122 of 565
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981018
Page 123 of 565
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981019
Page 124 of 565
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981020
Page 125 of 565
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981021
Page 126 of 565
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/29/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: PROTOCOL DEVIATION
4.Specify Status: [Subject received outside EAU vaccine]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981022
Page 127 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981023
Page 128 of 565
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981024
Page 129 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Subject requested to be unblided but then received vaccination from an outside
source.]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981025
Page 130 of 565
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981026
Page 131 of 565
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981027
Page 132 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/29/2021
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981028
Page 133 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981029
Page 134 of 565
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Matherne Approved Mar-12-2021 12:26:37 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0981030
Page 135 of 565
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-21-2020 14:20:34 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981031
Page 136 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine,
but is to continue in the study per clarification sent
on 08SEP2020.
Not Done
FormOct-13-2020 12:23:44 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine,
but is to continue in the study per clarification sent
on 08SEP2020.
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981032
Page 137 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981033
Page 138 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981034
Page 139 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981035
Page 140 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
4Oct-13-2020 12:24:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981036
Page 141 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981037
Page 142 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
6Oct-13-2020 12:25:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981038
Page 143 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981039
Page 144 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981040
Page 145 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981041
Page 146 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
10Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981042
Page 147 of 565
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
11Oct-14-2020 16:18:58 (UTC-06:00) Central Time
(US & Canada)Subject tested positive between first and second
visit. This means he can not get second vaccine, but
is to continue in the study per clarification sent on
08SEP2020.
Not Done
11Oct-13-2020 12:26:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0981043
Page 148 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-09-2020 11:42:52 (UTC-06:00) Central Time
(US & Canada)
FormOct-01-2020 14:33:17 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981044
Page 149 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-09-2020 11:42:52 (UTC-06:00) Central Time
(US & Canada)
1Oct-01-2020 14:33:17 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981045
Page 150 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-09-2020 11:42:52 (UTC-06:00) Central Time
(US & Canada)
2Oct-01-2020 14:33:17 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981046
Page 151 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-09-2020 11:42:52 (UTC-06:00) Central Time
(US & Canada)
3Oct-01-2020 14:33:17 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981047
Page 152 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-09-2020 11:42:52 (UTC-06:00) Central Time
(US & Canada)
4Oct-01-2020 14:33:17 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981048
Page 153 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981049
Page 154 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981050
Page 155 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981051
Page 156 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981052
Page 157 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981053
Page 158 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981054
Page 159 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-11-2020 08:23:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981055
Page 160 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:24:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981056
Page 161 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:24:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981057
Page 162 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:24:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981058
Page 163 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:24:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981059
Page 164 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:24:21 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981060
Page 165 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981061
Page 166 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981062
Page 167 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981063
Page 168 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981064
Page 169 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981065
Page 170 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981066
Page 171 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981067
Page 172 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981068
Page 173 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981069
Page 174 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981070
Page 175 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981071
Page 176 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981072
Page 177 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981073
Page 178 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981074
Page 179 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981075
Page 180 of 565
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981076
Page 181 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981077
Page 182 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981078
Page 183 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981079
Page 184 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981080
Page 185 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981081
Page 186 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981082
Page 187 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981083
Page 188 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981084
Page 189 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981085
Page 190 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981086
Page 191 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981087
Page 192 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981088
Page 193 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981089
Page 194 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981090
Page 195 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981091
Page 196 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981092
Page 197 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:24:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981093
Page 198 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981094
Page 199 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981095
Page 200 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981096
Page 201 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981097
Page 202 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981098
Page 203 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981099
Page 204 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981100
Page 205 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981101
Page 206 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981102
Page 207 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981103
Page 208 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981104
Page 209 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981105
Page 210 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981106
Page 211 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981107
Page 212 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981108
Page 213 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981109
Page 214 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981110
Page 215 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981111
Page 216 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981112
Page 217 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981113
Page 218 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981114
Page 219 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981115
Page 220 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981116
Page 221 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981117
Page 222 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.eNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981118
Page 223 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981119
Page 224 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981120
Page 225 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981121
Page 226 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.fNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981122
Page 227 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981123
Page 228 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981124
Page 229 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981125
Page 230 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.gNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981126
Page 231 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981127
Page 232 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981128
Page 233 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981129
Page 234 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.hNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981130
Page 235 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981131
Page 236 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981132
Page 237 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981133
Page 238 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.iNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981134
Page 239 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981135
Page 240 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981136
Page 241 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981137
Page 242 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.jNov-11-2020 08:25:13 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981138
Page 243 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:25:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981139
Page 244 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:25:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981140
Page 245 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:25:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981141
Page 246 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:25:41 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981142
Page 247 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981143
Page 248 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981144
Page 249 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981145
Page 250 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981146
Page 251 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981147
Page 252 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981148
Page 253 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-11-2020 08:26:10 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981149
Page 254 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-11-2020 08:26:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981150
Page 255 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-11-2020 08:26:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981151
Page 256 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-11-2020 08:26:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981152
Page 257 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-11-2020 08:26:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981153
Page 258 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-11-2020 08:26:36 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981154
Page 259 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981155
Page 260 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981156
Page 261 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981157
Page 262 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981158
Page 263 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981159
Page 264 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981160
Page 265 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981161
Page 266 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981162
Page 267 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981163
Page 268 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Nov-02-2020 10:46:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981164
Page 269 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-09-2020 11:41:50 (UTC-06:00) Central Time
(US & Canada)
FormNov-03-2020 11:44:22 (UTC-06:00) Central Time
(US & Canada)Not Done
FormNov-02-2020 10:47:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981165
Page 270 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-09-2020 11:41:50 (UTC-06:00) Central Time
(US & Canada)
1Nov-03-2020 11:44:22 (UTC-06:00) Central Time
(US & Canada)Not Done
1Nov-02-2020 10:47:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981166
Page 271 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-09-2020 11:41:50 (UTC-06:00) Central Time
(US & Canada)
2Nov-03-2020 11:44:22 (UTC-06:00) Central Time
(US & Canada)Not Done
2Nov-02-2020 10:47:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981167
Page 272 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-09-2020 11:41:50 (UTC-06:00) Central Time
(US & Canada)
3Nov-03-2020 11:44:22 (UTC-06:00) Central Time
(US & Canada)Not Done
3Nov-02-2020 10:47:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981168
Page 273 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-09-2020 11:41:50 (UTC-06:00) Central Time
(US & Canada)
4Nov-03-2020 11:44:22 (UTC-06:00) Central Time
(US & Canada)Not Done
4Nov-02-2020 10:47:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981169
Page 274 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981170
Page 275 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981171
Page 276 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981172
Page 277 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981173
Page 278 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981174
Page 279 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981175
Page 280 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Nov-02-2020 10:51:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981176
Page 281 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-02-2020 10:52:28 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981177
Page 282 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-02-2020 10:52:28 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981178
Page 283 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-02-2020 10:52:28 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981179
Page 284 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-02-2020 10:52:28 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981180
Page 285 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-02-2020 10:52:28 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981181
Page 286 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981182
Page 287 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Nov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981183
Page 288 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Nov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981184
Page 289 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Nov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981185
Page 290 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Nov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981186
Page 291 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981187
Page 292 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981188
Page 293 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981189
Page 294 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.aNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981190
Page 295 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981191
Page 296 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981192
Page 297 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981193
Page 298 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.bNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981194
Page 299 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981195
Page 300 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981196
Page 301 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981197
Page 302 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.cNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981198
Page 303 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0981199
Page 304 of 565
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161253 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5.dNov-02-2020 10:52:51 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f2d\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
…[truncated]